List of Registered Drugs for January – December 2013

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DRUGS REGISTERED IN JANUARY 2013
DATE
37)
PRODUCT
GENERIC
DESIGNATION
MANUFACTURER
LOCAL AGENT CLASSIFICATION
STATUS
14.01.13 Health 2000
Enalapril maleate USP
Enalapril 10mg 10mg
Tablets
14.01.13 X’tor 10 film
Atorvastatin 10mg
coated tablets
S Kant Healthcare
Limited, India
Health Brands
Limited
Antihypertensive
List 4
Ipca Laboratories
Limited, India
Antihyperlipidemic
agent
List 4
39)
18.01.13 Cloprez 75mg
Film-Coated
Tablets
Clopidogrel 75 mg
MSN Laboratories
Limited, Andhra
Pradesh, India
Servi-Care
Distributors
Limited
Medical
Products
Limited
Antiplatelet Agent
List 4
40)
18.01.13 Xiomida
300mg Film
Coated Tablets
18.01.13 Glemont-CT4
Chewable
Tablets
18.01.13 Valsaden
320mg/25mg
Film Coated
Tablets
31.01.13 Valsacor
320mg Film
Coated Tablets
31.01.13 Valsacor
160mg Film
Coated Tablets
Oxcarbazepine 300mg
Jubilant Life Sciences
Limited, Uttarakhand,
India
Glenmark
Pharmaceuticals
Limited, India
Krka dd Novo
Mestro, Slovenia
Medical
Products
Limited
T. Geddes Grant
Distributors Ltd
Anticonvulsants
List 4
Servi-Care
Distributors Ltd
Antihypertensive
List 4
Valsartan 320mg
Krka dd Novo
Mestro, Slovenia
Servi-Care
Distributors Ltd
Antihypertensive
List 4
Valsartan 160mg
Krka dd Novo
Mestro, Slovenia
Servi-Care
Distributors Ltd
Antihypertensive
List 4
38)
41)
42)
43)
44)
Montelukast Sodium
equivalent to
Montelukast 4mg)
Valsartan 320mg &
Hydrochlorothiazide
25mg
Leukotriene modifiers List 4
14.01.13
45)
Boostrix
suspension for
injection in
prefilled
Syringepreservative
free monodose
31.01.13 Valsacor 80mg
Film Coated
Tablets
Each dose (0.5ml)
contains:Diphtheria
toxoid not less than 2IU,
Tetanu toxoid not less
than 20IU, Prtussis
toxoid 8mcg,
Filamentous
haemagglutinin 8mcg,
Pertactin 2.5mcg,
Adsorbed on aluminium
hydroxide (ALCOH3)
0.3mg A13+, and
aluminum phosphate
(ALPO4) 0.2MG A13+
Valsartan 80mg
GlaxoSmithKline
Biologicals S.A.,
Belgium
GlaxoSmithKline Toxoid
Caribbean
Limited
List 4
Krka dd Novo
Mestro, Slovenia
Servi-Care
Distributors Ltd
List 4
Antihypertensive
DRUGS REGISTERED IN JANUARY 2013
DATE
PRODUCT
GENERIC
DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
1)
28.01.13 Prostatin Premium Male Each capsule contains
Formula Capsules
vitamin B12 3mcg, Zinc
7.5mg, selenium 50mcg,
proprietary blend 250mg
Alfa Vitamins
Laboratories Inc, USA
Facey Commodity
Company Ltd
Vitamins &
Minerals
List 2
2)
28.01.13 Vision Support
Capsules
Alfa Vitamins
Laboratories Inc, USA
Facey Commodity
Company Ltd
Vitamins & Herbs
List 2
3)
28.01.13 Sleep Nice Capsules
Passion flower 100mg,
chamomile flowers 100mg
St. john’s wort herb 60mg
Alfa Vitamins
Laboratories Inc, USA
Facey Commodity
Company Ltd
Herbal
List 2
4)
28.01.13 Osteo X-1 tablets
Each tablet contains 100mg
ipriflavone, VitaminD3
equivalent to 133.33IU
Vitamin D
Alfa Vitamins
Laboratories Inc, USA
Facey Commodity
Company Ltd
Vitamins
List 2
-
DRUGS REGISTERED IN FEBRUARY 2013
DATE
5)
PRODUCT
05.02.13 Vitabiotics
PregnaCare His
and Her
ConceptionWellman
Conception
Tablets
GENERIC DESIGNATION
MANUFACTURER
Each tablet contains:Vitamin A, as
Thompson & Copper
Dry Vitamin A Acetate type
Ltd, Cheshire United
250CWS/A 750ug, Vitamin D3 100 Kingdom
CWS/AM {100,00iu/g} 15ug,
Vitamin C as L-Ascorbic acid DC
97% gran starch free 90mg,
Thiamin (vitamin B1) as Thiamin
Mononitrate DC 97% 12mg,
Vitamin B6 as Pyridoxine
Hydrochloride 97% 19mg,
Riboflavin (vitamin B2) as
Riboflavin 5mg, Vitamin B12 as
Cyanocobalamin {vitamin B12}
Crystalline 75ug, Biotin as D-Biotin
150ug, Folacin as Folic Acid 400mg,
Niacin {Vitamin B3} as
Nicotinamide 18mg, Pantothenic as
Calcium D-Pantothenate 10mg,
Vitamin E as Alpha Tocopheryl
Acid Succinate 30mg, L-Arginine
as L-Arginine Mono Hydrochloride
10mg, Iron as Ferrous Fumanate
6mg, Magnesium as Magnesium
Oxide 60mg, Zinc as Zinc Sulphate
Monohydrate 15mg, Manganese as
Manganese Sulphate Monohydrate
0.50mg, Copper as Copper
LOCAL AGENT
Cari-Med Limited
CLASSIFICATION
Vitamins &
Minerals
STATUS
List 2
Sulphate Dried 1mg, Chromium as
Chromium Trichloride 6H20 50ug,
Selenium as Sodium Selenate
Anhydrous 150ug, Siberian
Ginseng Extract as Siberian
Ginseng Extract 4:1 30mg, CoQ10
as Co-Enzyme Q10 2mg, LCarnitine Tartrate as L-Carnitine
Tartrate 50mg, Citrus
Bioflavonoids 60% as Citrus
Bioflavonoids 60% 10mg, LGlutathione as L-Glutathione
2.50mg, Maca as Maca Extract
250mg, Pine Bark Extract as Pine
Bark Extract 95%
Proanthocyanidins 30mg,
Octacosanol as Rice Bran 3mg,
Inositol as Inositol 40mg, Lycopene
Extract 5% as Lycopene
(Standardized Extract 5%) 1.5mg
DRUGS REGISTERED IN FEBRUARY 2013
DATE
6)
PRODUCT
05.02.13 Vitabiotics
Wellteen Plus
Omega 3Wellteen
Tablets
GENERIC DESIGNATION
MANUFACTURER
Each tablet contains:Vitamin A as
VitaminA acetate (dry type325) 400ug,
Natural Mixed Cartenoids as carocare nat.
betacarotene 20% V 2mg, Thiamin {vitamin
B1} as thiamin mononitrate DC 97% 6mg,
Riboflavin (vitamin B2) as Riboflavin 3mg,
Vitamin D3 as vitamin D3 100 CWS/AM
{100,00IU/g}20ug, Folacin (Flolic Acid) as
folic acid 400ug, Vitamin B12 as
Cyanocobalamin {vitamin B12} crystalline
15ug, Vitamin B6 as pyridoxine
hydrochloride 97% 8mg, Patothenic Acid
as Calcium D-Pantothenate 6mg, Biotin as
D-Biotin 75ug, Vitamin C as Ascorbic Acid
{vitamin C} DC 97% 80mg, Vitamin E as D
Alpha Tocopheryl Acid Succinate 8mg,
Niacin {vitamin B3} as Nicotinamide 18mg,
Zinc as Zinc Sulphate Monohydrate 15mg,
Iron as Ferrous Fumarate 12mg, Selenium
as Sodium Selenate Decahydrate 55ug,
Magnesium as Magnesium Oxide,
granulated USP 94mg, Manganese as
Manganese Sulphate Monohydrate 2mg,
Copper as Copper Sulphate Dried 1mg,
Iodine as Potassium Iodide 130ug,
Thompson & Copper Ltd,
Cheshire United Kingdom
LOCAL
AGENT
Cari-Med
Limited
CLASSIFICATION
Vitamins & Herbs
STATUS
List 2
Chromium as Chromium Trichloride 6H20
50ug, L-Carnitine Tartate as L-Carnitine
Tartrate 50mg, Green Tea Extract
{equivalent {as Green Tea Extract 8:1 40mg,
Cranberry {as Cranberry Extract 15:1 CRASTD 100mg, CoQ10 {as Co-Enzyme Q10
2mg
DRUGS REGISTERED IN FEBRUARY 2013
DATE
7)
8)
9)
10)
PRODUCT
05.02.13 Vitabiotics
Osteocare
Tablets
GENERIC DESIGNATION
Each tablet contains: Calcium {as
magnesium hydroxide) 800mg,
magnesium {as magnesium
hydroxide) 150mg, zinc (as zinc
sulphate monohydrate} 5mg,
vitamin D {as vitamin D3
(500IU/mg) EC) 5mcg
05.02.13 Health 2000 Each gel contains:Diclofenac
Diclofenac
diethylamine B.P., 1.16% w/v
Gel B.P.
(equivalent to diclofenac sodium
B.P. 1% w/w) in a gel base
06.02.13 Pectylin-C
Each tablet
Expectorant contains:Diphenhydramine
hydrochloride B.P., 14mg,
Ammonium Chloride B.P.,
135mg, Sodium Citrate P.p.,
1.1mg.
06.02.13 Clean and
Contains: Salicylic Acid 2%
Clear
Advantage
3-in-1
Foaming
Acne Wash
MANUFACTURER
LOCAL
AGENT
CLASSIFICATION
STATUS
Thompson &
Copper Ltd,
Cheshire United
Kingdom
Cari-Med
Limited
Minerals
List 2
M/S Tuton
Pharmaceuticals,
Gujarat, India
Health
Brands Ltd
Analgesic
List 2
Ipca Laboratories
Ltd, Sejavta, India
Servi-Care
Antihistamine,
Distributors Expectorant
Ltd,
Vee Pak Inc.,
Illinois, USA
Cari-Med
Limited
List 2
Keratolytic,bacteriocidal List 2
& comedolitic agent
DRUGS REGISTERED IN FEBRUARY 2013
DATE
11)
12)
PRODUCT
06.02.13 Neutrogena
Oil-Free
Acne Stress
Control
PowerCream
Wash
05.02.13 Vitabiotics
PregnaCare
His and
Her
ConceptionPregnacare
Conception
Tablets
GENERIC
DESIGNATION
Contains:
Salicylic Acid 2%
MANUFACTURER
Each tablet
contains:Natural
Mixed
Carotenoids as
Carocare Nat.
Betacarotene 20%
V 36mg, Thiamin
(vitamin B1) as
Thiamin
Mononitrate
8mg, Riboflavin
(vitamin B2) as
Riboflavin 5mg,
Vitamin D3 as
Vitamin D3 100
CWS/AM
{100,000 IU/g}
15ug, Folacin as
(Folic Acid) as
Folic Acid
Thompson &
Copper Ltd,
Cheshire United
Kingdom
Neutrogena
Corporation,
California, USA
LOCAL
CLASSIFICATION
STATUS
AGENT
Kirk
Keratolytic,bacteriocidal List 2
Distributors & comedolitic agent
Limited
Cari-Med
Limited
Vitamins & Minerals
List 2
400ug, Vitamin
B12 as Vitamin
B12 0.1% WS
{Cyanocobalamin
Prep.} 20ug,
Vitamin B6 as
Pyridoxine
Hydrochloride
10mg, Pyridoxine
Hydrochloride as
Calcium DPantothenate
6mg, Biotin as DBiotin 150ug,
Vitamin C as
Coated Ascorbic
Acid Type FC
90mg, Vitamin E
as D Alpha
Tocopheryl Acid
Succinate 30mg,
Niacin {Vitamin
B3} as
Nicotinamide
20mg, Zinc as
Zinc Sulphate
Monohydrate
15mg, Iron as
Ferrous
Fumarate 14mg,
Selenium as
Sodium Selenate
Anhydrous 50ug,
Magnesium as
Magnesium
Oxide
Granulated USP
60mg, Copper as
Copper Sulphate
Dried 1mg,
Iodine as
Potassium Iodide
140ug, Inositol as
Inositol 50mg, LArginine as LArginine Mono
Hydrochloride
{Veggie} 100mg,
N-Acetyl
Cysteine as NAcetyl Cysteine
IP 50mg
DRUGS REGISTERED IN FEBRUARY 2013
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
13)
05.02.13 Lergi Tablets
Cetirizine Hydrochloride B.P.
Tablets 10mg
Aurochem Laboratories (India),
Pvt. Ltd., India
Inter Commercial
Distributors
Limited
Antihistamine
List 2
14)
27.02.13 CO Q-10 30mg
Softgels
Coenzyme Q10
Alfa Vitamins Laboratories Inc,
USA
Facey Commodity
Company Ltd
Vitamins
List 2
15)
27.02.13 Aurovite-M
Syrup
Aurochem Laboratories (India),
Pvt. Ltd., India
Inter Commercial
Distributors
Limited
Vitamins
List 2
16)
27.02.13 Vitamin C
1000mg Tablets
Vitamin A Palmitate BP 3000IU,
Vitamin D³ BP 500IU, Vitamin B¹
BP 2mg, Riboflavin Sodium
Phosphate BP 1.2mg, Nicotinamide
BP 10mg, Vitamin B¹² BP 2.5mcg,
Vitamin C BP 40mg, Vitamin B6 BP
1mg, Flavoured Syrup Base q.s.,
per 5ml
Vitamin C 1000mg (Ascorbic acid)
Aurochem Laboratories (India),
Pvt. Ltd., India
Inter Commercial
Distributors
Limited
Vitamins
List 2
17)
27.02.13 Ultra B
Complex
Tablets
Facey Commodity
Company Ltd
Vitamins
List 2
Vitamin B¹ 100mg, Vitamin B²
Alfa Vitamins Laboratories Inc,
100mg, Vitamin B³ 100mg, Vitamin USA
B6 100mg, Folic Acid 800mcg,
Vitamin B¹² 100mcg, Biotin 500mcg,
Vitamin B5 100mg.
DRUGS REGISTERED IN FEBRUARY 2013
DATE
PRODUCT
18)
27.02.13 Triple Alflexil
Triple
Strength
Tablets
19)
27.02.13 Ginkgo Biloba
Capsules
20)
27.02.13 Ginseng with
Ginkgo Biloba
Tablets
21)
27.02.13 Relaxin
Capsules
22)
27.02.13 Senna Leaves
High Potency
Capsules
GENERIC
DESIGNATION
MANUFACTURER
LOCAL
AGENT
CLASSIFICATION
STATUS
Two tablets contain:
Glucosamine HCI
1500mg,Chondroitin
Complex 800mg, MSM
750mg)
Ginkgo biloba leaves
powder 300mg,Ginkgo
biloba leaves extract
60mg, 24%/6%
standardized
Ginseng root 150mg,
ginkgo biloba leaves
powder 50mg, ginkgo
biloba leaves extract 30mg
Each capsule contains:
Valerian root
100mg,Passion flower
100mg, chamomile flower
100mg)
Senna leaves 235mg
Alfa Vitamins
Laboratories Inc, USA
Facey
Commodity
Company Ltd
Herbal
List 2
Alfa Vitamins
Laboratories Inc, USA
Facey
Commodity
Company Ltd
Herbal
List 2
Alfa Vitamins
Laboratories Inc, USA
Facey
Commodity
Company Ltd
Herbal
List 2
Alfa Vitamins
Laboratories Inc, USA
Facey
Commodity
Company Ltd
Herbal
List 2
Alfa Vitamins
Laboratories Inc, USA
Facey
Commodity
Company Ltd
Herbal
List 2
DRUGS REGISTERED IN FEBRUARY 2013
DATE
PRODUCT
GENERIC
DESIGNATION
MANUFACTURER
Calcium carbonate
600mg,equivalent to
240mg of calcium}
Vitamin D 200IU
Black Cohosh 250mg
Alfa Vitamins
Laboratories Inc, USA
LOCAL
AGENT
CLASSIFICATION
STATUS
Facey
Commodity
Company Ltd
Vitamin & Mineral
List 2
Alfa Vitamins
Laboratories Inc, USA
Facey
Commodity
Company Ltd
Herbal
List 2
Herbal
List 2
23)
27.02.13 Calcium 600
+D Tablets
24)
27.02.13 Black Cohosh
250mg
Capsules
25)
27.02.13 Vitamin B¹²
1000mcg
Tablets
Vitamin B¹² 1000mcg
Alfa Vitamins
Laboratories Inc, USA
Facey
Commodity
Company Ltd
26)
27.02.13 Aminopep
Forte Liquid
Amino Acid,
Multivitamins & Mineral
Syrup
Indus
Pharmaceuticals,
Chennai, India
UniMed Health Vitamins & Minerals
Care Limited
List 2
27)
27.02.13 Alcof-C Cough Dextromethorphan
Syrup
Hydrobromide BP 10mg,
Cetirizine Hydrochloride
BP 5mg, Phenylephrine
Hydrochloride BP 5mg,
Menthol BP 1.5mg per
5ml.
Aurochem
Laboratories (India),
Pvt. Ltd., India
Inter
Commercial
Distributors
Limited
List 2
Cough suppresant,
Nasal Decogestant,
Antihistamine
DRUGS REGISTERED IN FEBRUARY 2013
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
28)
27.02.13 Alcof-D
Cough Syrup
Chlorpheniramine Maleate BP 4mg,
Aurochem Laboratories
Phenylephrine Hydrochloride BP 5mg, (India), Pvt. Ltd., India
Dextromethorphan Hydrobromide BP
10mg, Menthol BP 0.5mg per 5ml
Inter Commercial
Antihistamine, Nasal
Distributors Limited Decogestant, Cough
Suppressant
List 2
29)
27.02.13 Capsitop Gel
Capsaicin USP {as capsicum oleoresin}
0.025% w/w, Diclofenac diethylamine
BP 1.160% w/w, Levomenthol BP 1%
w/w, Methyl Salicylate BP 3% w/w.
Stedman
Pharmaceuticals, Pvt.
TamilNadu, India
UniMed Health
Care Limited
Topical Anesthetic
List 2
30)
27.02.13 Sanidex
Solution
(Activator
Powder)
Activated Glutaraldehyde Solution 2%
w/v & Activator Powder
Sirmaxo Chemicals, Pvt.
Ltd., Thane, India
Lasco Distributors
Limited
Sterilant
List 2
DRUGS REGISTERED IN FEBRUARY 2013
DATE
31)
PRODUCT
27.02.13 Herbal Life
Formula 2
Multivitamin
Complex
GENERIC DESIGNATION
MANUFACTURER
Each tablet contains:Calcium Carbonate
Manhattan Drug
(37% CA} with Maltodextrin FG
Company Inc., New
302.58mg, Potassium Gluconate 189.8mg, Jersey
Microcrystallin Cellulose NF/PH
EUR/JP 173.55mg, Magnesium Oxide
DC, Granular 125.06mg, Ascorbic Acid
{97%} DC 64.43mg, Niacinamide
USP/FCC 43.73mg, Zinc Gluconate
Granular 41.34mg, Croscarmellose
Sodium NF- NON-GMO 24mg, DLAlpha Tocopheryl Acetate {50%} 23mg,
Potassium Glycerphosphate 40% on rice
{10%K} 17mg, Magnesium Gluconate
Dihydrate 16.23mg, Beta Carotene
Beadlets {7.5%} 16mg, Pyridoxine
Hydrochloride USP 14.38mg, Biotin {1%
TRIT} in Microcrystalline Cellulose 12mg,
Stearic Acid {Vegetable grade} NF 12mg,
Tocopherols, natural mixed {30%} 12mg,
D-Calcium Pantothenate 10.12mg, Silicon
Dioxide NF 10mg, Magnesium Stearate
NF 10mg, Riboflavin 95%, fine granular
on HPMC 10.5mg, Betaine Hydrochloride
10mg, Hydoxypropyl Methlcellulose
8.95mg, Thiamine Mononitrate 8.55mg,
Lycopene Beadlets 5% VBAF 7.92mg,
LOCAL AGENT CLASSIFICATION
Herbalife
International of
America Inc
Vitamins, Minerals
& Herbs
STATUS
List 2
Ferrous Fumarate Powder 7.06mg,
Xangold Lutein 10% GFB 3.96mg,
Chromium Chloride {1% CR} on DCP
3.8005mg, Copper Gluconate 3.78mg, LSelenomethionine {0.5% SE on Calcium
Phosphate Dibasic} Kosher 3.57mg,
Vanadium Amino Acid Chelate {0.1%
Vanadium} 2mg, Inositol 2mg, Choline
Bitartrate Coated 2mg, Vitamin D³ GFP
{100.000 IU/G} 1.93mg, Potassium Iodide
3% TRIT on Calcium Phosphate Dibasic
1.92mg, Folic Acid {10% TRIT.} 1.66mg,
Carrot Powder 1mg, Vegetable Powder
1mg, Soinach Powder 1mg, Glycerine
USP {99%}, Kosher 0.99mg, Grape Skin
Powder 1mg, Pomegranate Polyphenol
Extract Blend 1mg, Citrus Bioflavonoids
Powder {25%} 1mg, Cyanocobalamin {1%
TRIT. IN DCP} 0.29mg
DRUGS REGISTERED IN FEBRUARY 2013
DATE
PRODUCT
32)
27.02.13 Male Factor
1000 Capsules
33)
27.02.13 Green Tea
300mg
Capsules
GENERIC
DESIGNATION
Each tablet
contains:Calcium
Carbonate (37% CA}
with Maltodextrin 0.125
258mg, Green Oat PE
5:1 150mg, Nettle Leaf
Extract 5:1 75mg,
Ascorbic Acid {99%}
55mg, Sea Buckthorn
Powder 50mg,
Eleutherococcus
Hydroalcoholic SprayDried 0.5% 2.5mg,
Ginseng Leaf Extract
Ginsenosides 30%
2.5mg.
Green tea leaves 300mg
per capsule
MANUFACTURER
Manhattan Drug
Company Inc., New
Jersey
LOCAL AGENT
CLASSIFICATION
STATUS
Herbalife
International of
America Inc
Herbal
List 2
Herbal
List 1
Alfa Vitamins
Facey
Laboratories Inc, USA Commodity
Company Ltd
DRUGS REGISTERED IN FEBRUARY 2013
DATE
PRODUCT
27.02.13 Alcof Cough
Expectorant
GENERIC
DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
Chlorpheniramine Maleate
BP 2.2mg, Ammonium
Chloride BP 110mg,
Sodium Citrate BP 50mg,
Menthol BP 1.1mg per 5ml.
Wheat Dextrin 100%
Powder 3g per serving
Aurochem Laboratories
(India), Pvt. Ltd., India
Inter Commercial
Distributors Limited
Expectorant,Antihistamine,
List 1
Novartis Consumer
Health Inc., Nebraska,
USA
Cari-Med Limited
Dietary Fibre
List 1
19.02.13 Incivo FilmCoated Tablets
375mg
Telaprevir 375 mg
Janssen_Cilag S.p.A., Via
C. Janssen, Latina, Italy
Cari-Med Ltd
Antiviral Agent
List 4
19.02.13 Valsaden
80mg/12.5mg
Film-coated
Tablets
27.02.13 Valsaden
160mg/12.5mg
Film-coated
Tablets
Valsartan 80mg,
hydrochlorothiazide
12.5mg
Krka d.d., Novo Mesto,
Slovenia
Servi-Care
Distributors Ltd.
Antihypertensive
List 4
Valsartan 160mg,
hydrochlorothiazide
12.5mg
Krka d.d., Novo Mesto,
Slovenia
Servi-Care
Distributors Ltd.
Antihypertensive
List 4
27.02.13 Benefibre
Wheat Dextrin
Powder
DRUGS REGISTERED IN MARCH 2013
DATE
PRODUCT
GENERIC
DESIGNATION
MANUFACTURER
LOCAL
AGENT
CLASSIFICATION
STATUS
13.03.13 Roswera 5mg
Film-coated
Tablets
Rosuvastatin Calcium
5mg
Krka d.d., Novo
Mesto, Slovenia
Servi-Care
Distributors
Ltd.
Antihyperlipidemic
agent
List 4
13.03.13 Health 2000
Simvastatin
40mg Tablets
Simvastatin 40mg USP
Skant Healthcare Ltd.,
India
Health Brands
Limited
Antihyperlipidemic
agent
List 4
14.03.13 Roswera 20mg
Film-coated
Tablets
Rosuvastatin Calcium
20mg
Krka d.d., Novo
Mesto, Slovenia
Servi-Care
Distributors
Ltd.
Antihyperlipidemic
agent
List 4
14.03.13 Roswera 10mg
Film-coated
Tablets
Rosuvastatin Calcium
10mg
Krka d.d., Novo
Mesto, Slovenia
Servi-Care
Distributors
Ltd.
Antihyperlipidemic
agent
List 4
14.03.13 Roswera 40mg
Film-coated
Tablets
Rosuvastatin Calcium
40mg
Krka d.d., Novo
Mesto, Slovenia
Servi-Care
Distributors
Ltd.
Antihyperlipidemic
agent
List 4
15.03.13 ApoRosuvastatin
10mg Tablets
Rosuvastatin Calcium
10mg
Apotex Incorporated,
Canada
Cari-Med
Limited
Antihyperlipidemic
agent
List 4
55)
15.03.13 ApoRosuvastatin
20mg Tablets
Rosuvastatin Calcium
20mg
Apotex Incorporated,
Canada
Cari-Med
Limited
Antihyperlipidemic
agent
List 4
56)
18.03.13 Lopinavir and
Ritonavir
200/50mg
Tablets
Lopinavir 200mg,
Ritonavir 50mg
Cipla Limited, India
Lasco
Distributors
Limited
Antiviral Agent
List 4
57)
18.03.13 Lamivudine and
Tenofovir
Disoproxil
Fumarate
Tablets
300mg/300mg
18.03.13 Abacavir Sulfate
and Lamivudine
Tablets
Lamivudine USP 300mg,
Tenofovir Disoproxil
Fumarate 300mg
{equivalent to Tenofovir
Disoproxil 245mg})
Cipla Limited, India
Lasco
Distributors
Limited
Antiviral Agent
List 4
Each uncoated tablet
Cipla Limited, India
contains:Abacavir sulfate
{equivalent to abacavir
60mg, Lamivudine USP
30mg})
Each film-coated tablet
Rottendorf Pharma
contains:250mg
GmbH, Germany
Levofloxacin {equivalent
to 256.23mg levofloxacin
hemihydrate})
Lasco
Distributors
Limited
Antiviral Agent
List 4
H.D. Hopwood
and Co. Ltd.
Antibiotic
List 4
58)
59)
19.03.13 Levo-Denk 250
Film-Coated
Tablets
DRUGS REGISTERED IN MARCH 2013
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
60)
19.03.13 Lancer 30
Delayed
Release
Capsules
Lansoprazole 30mg USP
Aurochem
Pharmaceuticals (India),
Pvt. Ltd.
Inter Commercial
Distributors, Ltd
Proton Pump
Inhibitor
List 4
61)
25.03.13 Saphris 5mg
Sublingual
Tablets
Contains: Asenapine maleate 7.03mg
equivalent to asenapine 5mg
Catalent UK Swindon
Zydis Ltd., UK
Health Brands
Limited
Antipsychotics
List 4
62)
25.03.13 Saphris 10mg
Sublingual
Tablets
Contains: Asenapine maleate 14.06mg Catalent UK Swindon
equivalent to 10mg asenapine
Zydis Ltd., UK
Health Brands
Limited
Antipsychotics
List 4
63)
25.03.13 Cortiflow
Inhaler CFC
Free
Each actuation delivers Anhydrous
Beclometasone Dipropionate B.P.,
50mcg, suspended in propellant HFA
134a (1,1,1,2 Tetrafluoroethane)
M/S Midas-Care
Unimed Limited
Pharmaceticals, Pvt., Ltd.,
Aurangabed, India
Steroid-inhaled
List 4
64)
25.03.13 Sodium
Chloride
Intravenous
Infusion B.P
.9% w/v) NS (Each 100ml contains:
Sodium Chloride B.P., 900mg
Ahlcon Parenterals
(India) Ltd., Rajasthan,
India
Medical Products
Limited
Parental Nutrition
List 4
65)
25.03.13 Cadigrel
Tablets 75mg
Each film-coated tablet contains:
Cadila Pharmaceuticals
Clopidogrel Bisulfate USP {equivalent Ltd., Gujarat, India
to Clopidogrel 75mg
New Vision
Distributors Limited
Antiplatelet Agent
List 4
DRUGS REGISTERED IN MARCH 2013
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
66)
25.03.13 Intacape 500
Tablets
Each contains: Capecitabine USP 500mg
Intas Pharmaceuticals
Ltd., India
67)
26.03.13 Implanon
Implant 68mg
Each implant contains: 68mg of etonogestrel
N.V. Organon, OSS, The
Netherlands
68)
27.03.13 Posicaine 100
Injection
Contains: Articaine HCI 4% with Epinephrine
1:100,000)
69)
27.03.13 Posicaine 200
Injection
Contains:Articaine HCI 4% with Epinephrine
1:200,000
70)
27.03.13 Broncochem
Flu Remedy
Caplets
Acetaminophen 500mg, Bromhexine HCL
8mg, Phenylephrine 5mg, Chlorphenirmine
71)
27.03.13 ApoEscitalopram
10mg Tablets
Contains: Escitalopram Oxalate 10mg
LOCAL
AGENT
CLASSIFICATION
STATUS
Lascelles
Laboratories
Ltd
Health Brands
Limited
Anitneoplastics
List 4
ContraceptiveProgestins
List 4
Novocol Pharmaceutical
of Canada Inc., Ontario,
Canada
Glenn Logan
Anaesthetic
List 4
Novocol Pharmaceutical
of Canada Inc., Ontario,
Canada
Magnachem
International
Laboratory, San
Cristobal, Dominican
Rep.
Apotex Research Private
Ltd., Bangalore, India
Glenn Logan
Anaesthetic
List 4
Qualcare
Limited
Antihistamine,Pain
reliever,Mucolytic
Agent
List 4
Cari-Med
Limited
Antidepressant
List 4
72)
28.03.13 Cisplatin
Injection B.P.,
50ml for I.V.
Infusion
Each 50ml vial contains: Cisplatin, B.P.50mg
Naprod Life Sciences
PVT. Ltd., Dist. Thane,
India
Inter
Commercial
Distributors
Ltd.
Antineoplastics
List 4
28.03.13 Etoposide
Injection U.S.P.
100mg/5ml
Each 5ml vial contains: Etoposide U.S.P,100mg
Naprod Life Sciences
PVT. Ltd., Dist. Thane,
India
Inter
Commercial
Distributors
Ltd
Antineoplastics
List 4
DRUGS REGISTERED IN APRIL 2013
DATE
5-4-13
5-4-13
5-4-13
5-4-13
5-4-13
PRODUCT
Zoteon Podhaler
28mg Inhalation
Powder Hard
Capsules
Ribomustin 25mg
powder for
concentrate for
solution for
infusion
Ribomustin 100
mg powder for
concentrate for
solution for
infusion
Triben Plus Ear
Drops
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
REQUIREMENTS
FOR USE
Adult use; children
age 6 and over
Tobramycin
Novartis
Pharmaceuticals
Corporation, USA
Cari-Med Limited Respiratory
List 4
Bendamustine Hydrochloride
Thissen Laboratories
SA, Belgium
Cari-Med Limited Alkylating Agents
List 4
Adult use only
Bendamustine Hydrochloride
Thissen Laboratories
SA, Belgium
Cari-Med Limited Alkylating Agents
List 4
Adult use only
Overleaf not seen
Jenburkt
Pharmaceuticals Ltd,
India
Apotex Inc, Canada
Pulse Medicine
and Surgicals
List 4
Adult use only
12-4-13
Apo-Letrozole 2.5 Letrozole USP
mg tablets
Telma 20 tablets
Telmisartan BP 20 mg
12-4-13
Telma 40 tablets
Telmisartan BP 40 mg
Otic Antibiotic
Cari-Med Limited Anti-Cancer Agent
Glenmark
T. Geddes Grant
Pharmaceuticals
Distributors
Limited, India
Limited
Glenmark
T. Geddes Grant
Pharmaceuticals
Distributors
Limited, India
Limited
DRUGS REGISTERED IN APRIL 2013
List 4
Adult use only
Anti-hypertension
List 4
Adult use only
Anti-hypertension
List 4
Adult use only
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
List 4
REQUIREMENTS
FOR USE
Adult use only
12-4-13
Telma 80 tablets
Telmisartan BP 80 mg
Glenmark
Pharmaceuticals
Limited, India
T. Geddes Grant
Distributors
Limited
Anti-hypertension
12-4-13
Multiplex Syrup
Indus Pharmaceuticals
Arlab (India) Pvt, Ltd,
Alathur, India
Unimed Health
Care Limited
Nutritional
List 2
Adult use only
12.4.13
Ardyss-LeVine
Green Dietary
Supplement
Aseptic Solutions,
California, USA
Uni-Med Health
Care Limited
Nutritional
List 2
Adult use only
12.4.13
Ardyss-Multiplus
Dietary
Supplement
Vitamin A Palmitate USP 1500 IU,
Vitamin D3 USP 200 IU, Vitamin
B1 BP 1.5mg, Vitamin B2 5’ Phos.
Sod. BP 1.75mg, Vitamin B6 BP
0.5mg, Vitamin B12 BP 2.5mcg,
Vitamin C BP 25mg, Niacinamide
BP 12.5mg, L.Lysine mono
Hydrochloride USP 100mg, Zinc
Sulphate USP 8.25mg, Vitamin E
USP 0.5mg, Dexpanthenol USP
1.00mg
Aloe vera juice (from concentrate)
7.5g, milk thistle extract 180mg,
alfalfa herb extract 120mg,
artichoke extract 120mg, senna leaf
extract 120mg, gamma oryzanol
120mg, licorice extract
deglycyrrihizinated 60mg,
schizandra berry extract 60mg,
ginger root extract 1.5mg, sodium
copper chlorophyllin (mulberry
leaf extract) 1.2mg; per 30ml
Vitamin A (50% as beta carotene
and 50% as vitamin A palmitate)
5,000 IU, vitamin C (as ascorbic
acid) 500mg, vitamin D (as
cholecalciferol) 200 IU, vitamin E
Aseptic Solutions,
California, USA
Uni-Med Health
Care Limited
Nutritional
List 2
Adult use only
DATE
PRODUCT
18-4-13
Ciprocip 500
tablets
18-4-13
Ranitidine 300mg
tablets (BP)
18-4-13
Ranitidine 150mg
tablets (BP)
(as d-alpha tocophreyl acetate) 30
IU, vitamin K (as phytonadione)
40mcg, thiamin (as thiamine
GENERIC DESIGNATION
phytonadione) 1.5mg, riboflavin
(as riboflavin-5 phosphate) 1.7mg,
niacin (as niacinamide) 20mg,
vitamin B6 (as pyridoxine
hydrochloride) 2mg, biotin (as dbiotin) 150mcg, pantothenic acid
(as calcium Pantothenate) 10mg,
calcium (as calcium chloride)
50mg, magnesium (as magnesium
sulfate) 20mg, zinc (as zinc sulfate)
15mg, selenium (as sodium
selenite) 70mcg, copper (as cupric
sulfate) 1mg, manganese (as
manganese chelate) 2mg,
chromium (as chromium
polynicotinate) 120mcg, potassium
(as potassium citrate) 75mg; per
30ml
Ciprofloxacin hydrochloride
equivalent to ciprofloxacin BP
500mg
Ranitidine hydrochloride 336
mg equivalent to ranitideine 300
mg
Ranitidine 150 mg
MANUFACTURER
Flagship Biotech
International, India
Flagship Biotech
International, India
Flagship Biotech
International, India
CLASSIFICATION
Uni-Med
Distributors
Limited
Uni-Med
Distributors
Limited
Uni-Med
Distributors
Limited
Antibiotic
List 4
Age 17 and over
H2RB
List 4
Adult use only
H2RB
List 4
Adult use only
DRUGS REGISTERED IN APRIL 2013
STATUS
REQUIREMENTS
FOR USE
LOCAL AGENT
19-4-13
DATE
Flogrel 75 mg
tablets
PRODUCT
Clopidogrel bisulphate 97.87
mg equivalent to clopidogrel 75
mg
GENERIC DESIGNATION
Flagship Biotech
International, India
MANUFACTURER
Uni-Med
Distributors
Limited
LOCAL AGENT
List 4
CLASSIFICATION
STATUS
Adult use
REQUIREMENTS
FOR USE
Adult use only
17-4-13
Thycarzole 5 mg
tablets
Carbimazole 5mg BP
Unicure Remedies PVT. Health Brands
Ltd India
Limited
AntiHyperthyroidism
List 4
17-4-13
Air-o-vent
Inhaler CFC Free
Overleaf not seen
M/S Midas-Care
Pharmaceuticals,
Aurangabad, India
UniMed
Distributors
Limited
Respiratory
List 4
Adult and children
use
19-4-13
Aprovasc
150mg/5mg film
coated tablets
Aprovasc
300mg/5mg film
coated tablets
Aprovasc
300mg/10mg
film coated
tablets
Aprovasc
150mg/10mg
film coated
tablets
Irbesartan 150mg/Amlodipine
besilate 5 mg
Sanofi Aventis De
Mexico, SA De CV
Ocayoacac, Mexico
Sanofi Aventis De
Mexico, SA De CV
Ocayoacac, Mexico
Sanofi Aventis De
Mexico, SA De CV
Ocayoacac, Mexico
H.D. Hopwood
Anit-hypertension
List 4
Adult use only
H.D. Hopwood
Anit-hypertension
List 4
Adult use only
H.D. Hopwood
Anit-hypertension
List 4
Adult use only
Sanofi Aventis De
Mexico, SA De CV
Ocayoacac, Mexico
H.D. Hopwood
Anit-hypertension
List 4
Adult use only
19-4-13
19-4-13
19-4-13
Irbesartan 300mg/Amlodipine
besilate 5 mg
Irbesartan 300mg/Amlodipine
besilate 10 mg
Irbesartan 150mg/Amlodipine
besilate 10 mg
DRUGS REGISTERED IN APRIL 2013
19-4-13
Intelence 200mg
tablets
Etravirine 200 mg
Janssen-Cilag S.p.A.
Latina, Italy
Cari-Med Limited Anti-viral
List 4
Age 6 and over
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
Doxorubicin hydrochloride BP
10 mg
Naprod Life Sciences
Pvt Ltd Dist Than India
Inter-Commercial
Distributors
Limited
Anti-Cancer
List 4
REQUIREMENTS
FOR USE
Adult use only
Doxorubicin
Hydrochloride
for injection BP
50mg/vial
Doxorubicin hydrochloride BP
50 mg
Naprod Life Sciences
Pvt Ltd Dist Than India
Inter-Commercial
Distributors
Limited
Anti-Cancer
List 4
Adult use only
22-4-13
Afinitor 5mg
tablets
Everloimus 5mg
Novartis Pharma Stein
AG Switzerland
Cari-Med Limited Anti-Cancer
List 4
Adult use only
24-4-13
Flucosyst-150
capsule
Fluconazole 150 mg USP
Indies Pharma
Anti-Fungal
List 4
Adult use only
23-4-13
Bioprist Atenolol- Atenolol 50 mg BP
50 tablets
Indies Pharma
Anti-hypertension
List 4
Adult use only
23-4-13
Neutrogena OilFree Acne Wash
Redness Soothing
Facial Cleanser
Liquid
Medicamen Biotech
Limited Rojasthan,
India
Medicamen Biotech
Limited Rojasthan,
India
Vee Pak Inc, USA
List 4
Adult use only
DATE
PRODUCT
GENERIC DESIGNATION
19-4-13
Doxorubicin
Hydrochloride
for injection BP
10mg/vial
19-4-13
Salicylic Acid 2% w/w
Cari-Med Limited
DRUGS REGISTERED IN APRIL 2013
18-4-13
DATE
23-4-13
Moxflag 500
Capsules
PRODUCT
Health 2000
Fexophen 180
tablets
Amoxicillin trihydrate BP
599.37mg equivalent to
amoxicillin 500mg BP
Flagship Biotech
International, India
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
Fexofenadine hydrochloride 180 Unicure Remedies PVT Health Brands
mg BP
LTD, India
Limited
29-4-13
Pantoking
Injection; for IV
use; 40 mg per
vial; lyophilized
Pantoprazole sodium USP
equivalent to pantoprazole
40mg
25-4-13
Health 2000
Doxorubicin
Hydrochloride
for Injection 10
mg
Doxorubicin hydrochloride USP M/S Health Biotech
10mg
Ltd, Dist Solan, India
15.04.13 Zoteon Podhaler
28mg Inhalation
Powder
UniMed
Distributors
Limited
Contains: Tobramycin
DRUGS REGISTERED IN MAY 2013
M/S Flagship Biotech
International, Gujarat,
India
Novartis Pharma
Schweiz, AG
Switzerland
Antibiotic
CLASSIFICATION
Antihistamine
List 4
STATUS
List 4
Age 6 and over
REQUIREMENTS
Adult
only
FORuse
USE
Unimed
Distributors
Limited
Proton pump
inbitor
List 4
Adult use only
Health Brands
Limited
Anti-Cancer
List 4
Adult use only
Cari-Med
Limited
Antibiotic
List 4
1-5-13
1-5-13
DATE
1-5-13
1-5-13
3-5-13
Efcure-600 tablets
Meropenem for
PRODUCT
injection USP
500mg; vials for
IV use
Dextrose injection
BP 5% w/v
(50g/1) for IV
use; 500ml plastic
bags
Sodium chloride
(0.9%w/v) and
Dextrose
(5%w/v)
injection BP for
IV use; 500ml
plastic bags
Famy-Depo
Contraceptive
Injection 1ml vial;
IM use only
Efavirenz 600 mg
M/S Emcure
Pharmaceuticals Ltd,
Pun, India
Meropenem
USP equivalent to MANUFACTURER
Mepromax Life
GENERIC
DESIGNATION
meropenem (anhydrous) 500
Sciences Private Ltd,
mg
Selaquil India
Servi-Care
Distributors
Limited
Anti-viral
T.Geddes
Grant CLASSIFICATION
Antibiotic
LOCAL
AGENT
Distributors
Limited
List 4
List 4
STATUS
Adult use only
REQUIREMENTS
Adult use only
FOR USE
Dextrose anhydrous BP 5gm;
water for injection BP QS
Ahlcon Parenterals (I)
Ltd Rajasthan, India
Medical Products
Limited
Parenteral
List 4
Adult use only
Overleaf not seen
Ahlcon Parenterals (I)
Ltd Rajasthan, India
Medical Products
Limited
Parenteral
List 4
Adult use only
Medroxyprogesterone acetate
USP 150mg
Famy Care Ltd,
Ahmedabad, India
Qualcare Limited
Contraceptive
List 4
Adult use only
DRUGS REGISTERED IN MAY 2013
3-5-13
Pirsec
Omeprazole 20mg; sodium
Norwich
GSK Caribbean
20mg/1100mg
bicarbonate 1100mg
Pharmaceuticals Inc,
Limited
DATE capsules
PRODUCT
GENERIC DESIGNATION USA MANUFACTURER
LOCAL AGENT
List 4
CLASSIFICATION
Adult use only
REQUIREMENTS
STATUS
FOR USE
3-5-13
Pirsec
40mg/1100mg
capsules
Omeprazole 40mg; sodium
bicarbonate 1100mg
Norwich
Pharmaceuticals Inc,
USA
GSK Caribbean
Limited
List 4
Adult use only
3-5-13
Edurant 25 mg
Film-coated
tablets
Rilpivirine
Janssen Cilag S.p.A.
Italy
Cari-Med Limited Anti-viral
List 4
Adult use only
3-5-13
Inlyta 1mg Filmcoated tablets
Axitimib 1mg
Pfizer Manufacturing
Deutschland, GmbH,
Germany
H.D. Hopwood
Biologic
List 4
Adult use only
3-5-13
Inlyta 5mg Filmcoated tablets
Axitimib 5mg
H.D. Hopwood
Biologic
List 4
Adult use only
7-5-13
ZincOra
Indies Pharma
Jamaica Limited
Oral Rehydration
Salts
List 2
Adult use only
7-5-13
Zinc Ora
Oral Rehydration Salts BP 20.8g,
sodium chloride 2.6g, potassium
chloride 1.5g, sodium citrate 2.9g,
anhydrous glucose 13.5g, orange
flavor (dry) 0.3g per sachet
Zinc sulphate 57 mg USP as
monohydrate equivalent to
elemental zinc 20 mg tablets
Pfizer Manufacturing
Deutschland, GmbH,
Germany
Medicamen Biotech
Limited, Rajasthan,
India
Medicamen Biotech
Limited, Rajasthan,
India
Indies Pharma
Jamaica Limited
Oral Rehydration
Salts
List 2
Adult use only
7-5-13
L-Montus tablets
Levocetirizine dihydrochloride Fourrts (India)
5mg and Montelukast sodium
Laboratories Pvt. Ltd,
equivalent to Montelukast 10mg Chehnai India
Inter-Commercial
Distributors
Limited
Respiratory
List 4
Adult use only
7-5-13
Infen-25 tablets
Dexketoprofen trometamol
equivalent to Dexketoprofen 25
mg tablets
Emcure
Pharmaceuticals Ltd,
Maharashtra, India
Servi-Care
Distributors
limited
NSAID
List 4
Adult use only
9-7-13
Kudose 0.4mg
Prolonged
Release Capsules
Tamsulosin hydrochloride as
modified release pellets 0.4 mg
BP
Genpharma
International PVT Ltd,
India
Medical Products
Limited
α- blocker
List 4
Adult use only
10-5-13
Firmagon 120mg
Powder and
Solvent for
Solution for
injection
Degarelix 120mg as acetate
Rentschler
Biotechnolagie GmbH,
Germany
New Vision
Distributors
Anti-Neoplastic
Agent
DRUGS REGISTERED IN MAY 2013
List 4
Adult use only
DRUGS REGISTERED IN JUNE 2013
DATE
PRODUCT
25-6-13
Jarrow Formulas
Choless Optimizer
Tablets
Jarrow Formulas, Inc.,
California, USA
25-6-13
Jarrow Formulas
Pressure Optimizer
Tablets
Sav-Laton
Antiseptic Liquid
Jarrow Formulas, Inc.,
California, USA
Leading Brands
Jamaica Limited
List 1
Shirlome Chemical
Corporation Ltd., 63
Hagley Park Rd., Kgn
10, Jamaica
Ayrtons
Distributors (Ja.)
Co. Ltd.
List 1
25-6-13
GENERIC DESIGNATION
Cetrimide BP 3% w/v,
Chlorhexidine gluconate
Solution BP 1.5% equivalent
to Chlorehexidine Gluconate
0.3% w/v, Isopropyl Alcohol
BP 2.84% w/v)
MANUFACTURER
LOCAL AGENT
Leading Brands
Jamaica Limited
CLASSIFICATION
STATUS
List 2
25-6-13
Jarrow Formulas
Skin Optimizer
Capsules
Jarrow Formulas, Inc.,
California, USA
25-6-13
Jarrow Formulas
Bone-Up Capsules
Jarrow Formulas, Inc.,
California, USA
Leading Brands
Jamaica Limited
List 2
Jarrow Formulas, Inc.,
California, USA
Leading Brands
Jamaica Limited
List 2
25-6-13
Jarrow Formulas
Vision Optimizer
Capsules
Leading Brands
Jamaica Limited
List 1
REQUIREMENTS
FOR USE
DRUGS REGISTERED IN JUNE 2013
DATE
25-6-13
25-6-13
25-6-13
25-6-13
25-6-13
25-6-13
PRODUCT
Jarrow Formulas
Neuro Optimizer
Capsules
Systane Gel Drops
Lubricant Eye Gel
(Sterile)
Health 2000
Fexophen 120
Tablets
Relcer Gel Vanilla
Flavour
GENERIC DESIGNATION
Jarrow Formulas, Inc.,
California, USA
LOCAL AGENT
CLASSIFICATION
STATUS
Leading Brands
Jamaica Limited
List 2
List 2
Polyethylene Glycol 400 NF,
0.4% w/v,Propylene Glycol
USP 0.3% w/v.
Alcon Laboratories,
Inc., Texas, USA
Cari-Med
Limited
(Fexofenadine Hydrochloride
120mg USP)
Unicure Remedies
Pvt. Ltd., Baroda, India
Health Brands
Limited
T. Geddes Grant
Limited
List 2
BioTech R&D
Institute Ltd.
List 2
Ground Muscadine Grape
Seed 100% [vitis rotundifolia]
650mg
Glenmark
Pharmaceuticals
Limited, Mumbai,
India
First Priority
Manufacturer’s,
Washington, USA
Nature’s Pearl
Corporation, North
Carolina, USA
Nature’s Pearl
Corporation
List 1
Diabetes Formula
Capsules
Nature’s Pearl
Premium
Muscadine Grape
Seed Capsules
MANUFACTURER
Histamine blocker
List 2
REQUIREMNTS
FOR USE
DRUGS REGISTERED IN JUNE 2013
DATE
PRODUCT
25-6-13
Vidatox 30CH
Homeopathic
Product Sublingual
Drops
Venom of rhopalurus
junceus 30CH/0.01ml
6-6-13
Zelboraf 240mg
film-coated tablets
Esmeron 10mg/ml;
10mls solution for
IV injection or IV
infusion – vials
Apo-Rosuvastatin
5mg Tablets
Vemurafenib
Business Groups for
Biopharmaceutical and
Chemical Production,
LABIOFAM Vimang
Laboratory for Herbal
Medicine, Havana, Cuba
Roche S.p.A., Italy
Each 10ml vial contains:
rocuronium bromide 100mg
Hameln Pharmaceuticals,
Germany
Rosuvastatin calcium
Apotex Incorporated,
Canada
Veltam 0.4
modified release
tablets
Olanzapine Sandoz
5mg film-coated
tablets
Olanzapine Sandoz
10mg film-coated
tablets
Tamsulosin hydrochloride
USP 0.4mg
Intas Pharmaceuticals, India Lascelles Limited
Olanzapine
Sandoz Ilac, Turkey
Qualcare Limited
Anti-psychotic Agent
List 4
Olanzapine
Sandoz Ilac, Turkey
Qualcare Limited
Anti-psychotic Agent
List 4
10-6-13
7-6-13
11-6-13
11-6-13
11-6-13
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
Business Groups for
Biopharmaceutical
and Chemical
Production, Havana,
Cuba.
Facey Commodity Co.
Ltd.
MSD Sharp & Dohme,
GmbH C/o Health
Brands
Car-Med Limited
STATUS
List 4
Anti-Neoplastic
Agent
Muscle Relaxant
List 4
AntiHypercholesterolemic
Agent
List 4
List 4
List 4
α- blocker
REQUIREMENTS FOR
USE
DRUGS REGISTERED IN JUNE 2013
DATE
PRODUCT
12-6-13
Beclate 250
inhaler CFC
Free
Singulair 4mg
Oral Granules
10-6-13
14-6-13
14-6-13
17-6-13
Flagmine 60mg
Film-Coated
Tablets
Moxflag Oral
Suspension
250mg/5ml;
100ml
Carbimazole
5mg Tablets
GENERIC DESIGNATION
Beclometasone dipropionate BP
250mcg per actuation
Montelukast sodium
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
Cipla Limited,
India
Lasco Distributors
Limited
Respiratory Agent
DSM
Pharmaceuticals
Inc, NC, USA
Pyridostigmine bromide BP
60mg
Bharat Parenterals
Limited, India
Each 5ml of suspension contains
Amoxicillin trihydrate BP
equivalent to Amoxicillin 250mg
Flagship Biotech
International Ltd.,
India
Carbimazole BP 5mg
Alvita Pharma
Private Limited,
India
Laboratories Poen
S.A.C.I.F.I.,
Bermudez,
Argentina
Brussels
Laboratories Pvt.,
Ltd., India
14-6-13
Neagel Sterile
Ophthalmic Gel
Ganciclovir 0.15% 150mg/100g
20-6-13
Health 2000
Losartan
Potassium 50mg
Tablets
Losartan Potassium USP 50mg
STATUS
List 4
Health Brands
Limited
Respiratory
Agent/Leukotriene
Receptor Antagonist
List 4
UniMed
Distributors
Limited
UniMed
Distributors
Limited
Acetylcholinesterase
Inhibitor
List 4
Anti-biotic
List 4
UniMed
Distributors
Limited
T. Geddes Grant
Distributors
Limited
Anti-thyroid Agent
List 4
Anti-viral Agent
List 4
Anti-hypertensive
Agent
List 4
Health Brands
Limited
REQUIREMENTS
FOR USE
DRUGS REGISTERED IN JUNE 2013
DATE
PRODUCT
20-6-13
Health 2000
Ciprofloxacin
250mg Tablets
Health 2000
Ciprofloxacin
500mg Tablets
Clinex Lotion
1%
20-6-13
25-6-13
25-6-13
Haloperidol
Injection BP;
Ampoules;
IV/IM use
26-6-13
Health 2000
Nifedipine
Sustained
Release Tablets
20mg
Health 2000
Amlodipine
5mg Tablets
Health 2000
Amlodipine
10mg Tablets
26-6-13
GENERIC DESIGNATION
MANUFACTURER
Ciprofloxacin hydrochloride USP
equivalent to Ciprofloxacin
250mg
Ciprofloxacin hydrochloride USP
equivalent to Ciprofloxacin
500mg
Each 1ml contains: Clindamycin
phosphate USP equivalent to
Clindamycin 10mg
Each 1ml contains: Haloperidol
BP, 5mg
S Kant Healthcare
Ltd., India
S Kant Healthcare
Ltd., India
LOCAL AGENT
Health Brands
Limited
Health Brands
Limited
CLASSIFICATION
STATUS
Anti-biotic
List 4
Anti-biotic
List 4
Anti-biotic
List 4
Anti-psychotic
List 4
Aristopharma
Limited, Dhaka,
Bangladesh
M/S Flagship
Biotech
International,
Maharashtra State,
India
M/S Brussels
Laboratories Pvt.
Ltd., Gujarat State,
India
R.A. Williams
Distributors
Limited
UniMed
Distributors
Limited
Health Brands
Limited
Anti-hypertensive
Agent
List 4
Amlodipine besylate BP, 5mg
S Kant Healthcare
Ltd., Gujarat India
Health Brands
Limited
Anti-hypertensive
Agent
List 4
Amlodipine besylate BP, 10mg
S Kant Healthcare
Ltd., Gujarat India
Anti-hypertensive
Agent
List 4
Nifedipine USP, 20mg
Health Brands
Limited
REQUIREMENTS
FOR USE
DRUGS REGISTERED IN JUNE 2013
DATE
26-6-13
26-6-13
28-6-13
28-6-13
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
Efavirenz
600mg/Lamivudine
300mg, Tenofovir
Disoproxil Fumarate
300mg Tablets
Pepguard Injection Each vial contains:
(Lyophilized); vials; Esomeprazole sodium
for I.V. use
equivalent to Esomeprazole,
40mg
Teicobact-400
Each vial contains:
Injection; vials; for
Teicoplanin, 400mg
IV/IM use
Aurobindo Pharma
Limited, India
Intercommercial
Distributors Ltd
Anti-Retroviral
Agent (ARV)
List 4
Unimed
Distributors Ltd.
Proton Pump
Inhibitor (PPI)
List 4
Unimed
Distributors Ltd.
Anti-biotic
List 4
H.D Hopwood
Anti-biotic
List 4
Amoxiclav-Denk
1000/125 Powder
for Oral Suspension
M/S. Flagship
Biotech
International,
Gujarat State, India
M/S. Flagship
Biotech
International,
Gujarat State, India
Pencef Pharma
GmbH, Berlin,
Germany
REQUIREMENTS
FOR USE
DRUGS REGISTERED IN JULY 2013
DATE
PRODUCT
01-7-13
Apo-Lansoprazole
15mg DelayedRelease Capsules
Apo-Lansoprazole
30mg DelayedRelease Capsules
Gonapeptyl Depot
3.75mg Powder &
Solvent For
Suspension for
Injection; S.C. or I.M
use; Pre-filled
syringes
Arcoxia 30mg
Tablets
Health 2000
Dispersible
Aciclovir 800mg
Tablets
Glemont – CT5
Chewable Tablets
01-7-13
01-7-13
10-7-13
11-7-13
12-7-13
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
Lansoprazole U.S.P., 15mg
Apotex Inc.,
Ontario, Canada
Cari-Med Limited
Proton Pump
Inhibitor (PPI)
List 4
Lansoprazole U.S.P., 30mg
Apotex Inc.,
Ontario, Canada
Cari-Med Limited
Proton Pump
Inhibitor (PPI)
List 4
Ferring GmbH,
Wittland, Kiel,
Federal Republic of
Germany
New Vision
Distributors Ltd.
Leutinizing
Hormone Releasing
Hormone(LHRH)
analogue
List 4
Frosst Iberica,
Madrid, Spain
Unicure Remedies
PVT Ltd., India
Health Brands
Limited
Health Brands
Limited
COX II Inhibitor
List 4
Anti-viral Agent
List 4
Glenmark
Pharmaceutical
Ltd., India
T. Geddes Grant
Ltd.
Respiratory
Agent/Leukotriene
Receptor Antagonist
List 4
Etoricoxib 30mg
Aciclovir BP 800mg
Montelukast Sodium
{equivalent to
Montelukast 5mg}
REQUIREMENTS
FOR USE
DRUGS REGISTERED IN AUGUST 2013
DATE
PRODUCT
07-8-13
Health 2000
Captopril 25mg
Tablets
Panto-Denk 20
Gastro-Resistant
Tablets
09-8-13
09-8-13
12-8-13
12-8-13
12-8-13
GENERIC DESIGNATION
Captopril USP 25mg
Pantoprazole Sodium
Sesquihydrate 22.6mg
Equivalent to Pantoprazole
20mg
Panto-Denk 40
Pantoprazole Sodium
Gastro-Resistant
Sesquihydrate 45.1mg
Tablets
Equivalent to Pantoprazole
40mg
Simponi Solution for Golimumab 50mg/0.5ml
Injection in Prefilled Syringes
Carvedi-Denk 25
Tablets
Carvedi-Denk 6.25
Tablets
Carvedilol 25mg
Carvedilol 6.25mg
MANUFACTURER
Skant HealthCare
Ltd., India
LOCAL AGENT
Health Brands
Ltd.
CLASSIFICATION
STATUS
Anti-hypertensive
Agent
List 4
Advance Pharma
GmbH, Germany
H.D. Hopwood &
Co., Ltd.
Proton Pump
Inhibitor (PPI)
List 4
Advance Pharma
GmbH, Germany
H.D. Hopwood &
Co., Ltd.
Proton Pump
Inhibitor (PPI)
List 4
Baxter
Pharmaceuticals
Solution, LLC,
Indiana
Artesan Pharma
GmbH, Germany
Artesan Pharma
GmbH, Germany
Cari Med Ltd.
Human Monoclonal
Antibody
List 4
Anti-hypertensive
Agent/β-blocker
Anti-hypertensive
Agent/β-blocker
List 4
H.D. Hopwood
Company Ltd.
H.D. Hopwood
Company Ltd.
List 4
REQUIREMENTS
FOR USE
DRUGS REGISTERED IN SEPTEMBER 2013
DATE
09-9-13
09-9-13
09-9-13
17-9-13
17-9-13
25-09-13
20-9-13
PRODUCT
Quetiapine 200mg
Sandoz film-coated
tablets
Quetiapine 300mg
Sandoz film-coated
tablets
Health 2000
Ibuprofen 600mg
Tablets
Health 2000 Glidon
30 modified release
tablets
Health 2000 Glidon
60 modified release
tablets
Health 2000
Metformin HCL
Extended Release
500mg Tablets.
Allocol with Aloe
Vera
GENERIC DESIGNATION
MANUFACTURER
Quetiapine hemifumarate
230.26mg equivalent to
Quetiapine 200mg
Quetiapine hemifumarate
345.39mg equivalent to
Quetiapine 300mg
Ibuprofen BP 600mg
Sandoz Ilac Sanayi
Ve Ticaret, Turkey
LOCAL AGENT
CLASSIFICATION
STATUS
Qualcare Limited
Anti-psychotic Agent
List 4
Sandoz Ilac Sanayi
Ve Ticaret, Turkey
Qualcare Limited
Anti-psychotic Agent
List 4
Skant HealthCare
Ltd., India
Health Brands
Ltd.
NSAID
List 4
Gliclazide BP 30mg
Unicure Remedies
PVT Ltd., India
Health Brands Ltd.
List 4
Gliclazide BP 60mg
Unicure Remedies
PVT Ltd., India
Health Brands Ltd.
Metformin hydrochloride
USP 500mg
Skant Healthcare
Ltd., India
Health Brands Ltd.
AntiHyperglycaemic
Agent
AntiHyperglycaemic
Agent
AntiHyperglycaemic
Agent
Supreme Chemicals
Ltd., Weymouth
Close, Kingston 20
Allo Products
Mandeville,
Manchester,
Jamaica
List 4
List 4
List 1
REQUIREMENTS
FOR USE
DRUGS REGISTERED IN OCTOBER 2013
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
14-10-13
Organo Gold
Organic Ganoderma
Lucidum Spore
Powder Capsules
Organo Gold
Organic Ganoderma
Mycelium Capsules
Organo Gold
Organic Ganoderma
Lucidum Capsules
Fluarix Vaccine
Northern
Hemisphere20132014 Strain Update
Xalkori 200mg
Capsules
Reiishi Mushroom
{Ganoderma lucidum, spore}
250mg
Reena Enterprise Ltd.,
o/a Total Health Centre,
Ontario, Canada
Organo Gold
International
(Jamaica) Limited
List 2
Reiishi Mushroom
{Ganoderma lucidum,
mushroom 400mg
Reiishi Mushroom
{Ganoderma lucidum,
whole} 250mg
Reena Enterprise Ltd.,
o/a Total Health Centre,
Ontario, Canada
Reena Enterprise Ltd.,
o/a Total Health Centre,
Ontario, Canada
GlaxoSmithKline
Biologicals, Dresden,
Germany
Organo Gold
International
(Jamaica) Limited
Organo Gold
International
(Jamaica) Limited
GlaxoSmithKline
Caribbean Ltd.
List 2
H.D. Hopwood
Anti-Neoplastic
Agent
List 4
Xalkori 250mg
Capsules
Crizotinib 250mg
Pfizer Manufacturing
Deutschland GmbH,
Freiburg, Germany
Pfizer Manufacturing
Deutschland GmbH,
Freiburg, Germany
H.D. Hopwood
Anti-Neoplastic
Agent
List 4
14-10-13
14-10-13
8-10-13
8-10-13
8-10-13
Crizotinib 200mg
LOCAL AGENT
DRUGS REGISTERED IN OCTOBER 2013
CLASSIFICATION
STATUS
List 2
List 4
REQUIREMENTS
FOR USE
DATE
10-10-13
PRODUCT
GENERIC DESIGNATION
11-10-13
Opavia 5 Film-coated Olanzapine Ph. Eur 5mg
Tablets
Opavia 10 FilmOlanzapine Ph. Eur 10mg
coated Tablets
Telmimark 20 Tablets Telmisartan BP 20mg
11-10-13
Telmimark 40 Tablets Telmisartan BP 40mg
11-10-13
Telmimark 80 Tablets Telmisartan BP 80mg
14-10-13
Simponi Solution for
Injection in Pre-filled
Injector (Pen) (Single
use SmartJect Autoinjector) For
Subcutaneous
Injection.
Tenoretic 50–12.5mg
Tablets
Golimumab 50mg/0.5ml
Efavirenz
600mg/Emtricitabine
200mg/Tenofovir
Disoproxil fumarate
300mg tablets
Each film coated tablets
coantains efavirenz 600mg,
Emtricitabine 200mg,
Tenofovir disoproxil
fumarate 300mg
10-10-13
14-10-13
15-10-13
Atenolol 50mg,
Chlorthalidone 12.5mg
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
Jubilant Life
Sciences Ltd., India
Jubilant Life
Sciences Ltd., India
Marksans Pharma
Ltd., India
Marksans Pharma
Ltd., India
Marksans Pharma
Ltd., India
Baxter
Pharmaceuticals
Solution, LLC,
Indiana, USA
Medical Products
Limited
Medical Products
Limited
Health Brands Ltd.
Anti-psychotic
Agent
Anti-psychotic
Agent
Anti-hypertensive
Agent
Anti-hypertensive
Agent
Anti-hypertensive
Agent
Human Monoclonal
Antibody
List 4
AstraZeneca, S.A de
C.V., Fracc. Lomas
Verdes, Naucalpan
de Juárez, Mexico
Aurobindo Pharma
Ltd., India
Cari-Med Ltd.
Anti-hypertensive
Agent
List 4
Anti-Retroviral
Agent (ARV)
List 4
Health Brands Ltd.
Health Brands Ltd.
Cari-Med Ltd.
Inter-Commercial
Distributors Ltd.
DRUGS REGISTERED IN OCTOBER 2013
List 4
List 4
List 4
List 4
List 4
REQUIREMENTS
FOR USE
DATE
PRODUCT
15-10-13
Auropan Plus
Tablets
15-10-13
Otrimar Sea Water
with Aloe Vera
Nasal Spray
15-10-13
Epiduo Gel Pump
0.1%/2.5%
Anzavir R
300mg/100mg
Tablets
16-10-13
17-10-13
Nexoz 20 delayed
release tablets
17-10-13
Nexoz 40 delayed
release tablets
23-10-13
Health 2000 Digilan
125mcg Tablets
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
Hyoscine butylbromide BP
10mg, Paracetamol BP
500mg
5% aloe vare extract, 30%
sea water, purified water
Aurochem
Laboratories (India)
Pvt. Ltd.
SPPH Impasse des
Boussenots,
Quetigny Cedex,
France
G Production Inc.,
Canada
Mylan Laboratories
Limited, India
Inter-Commercial
Distributors Ltd.
List 4
Cari-Med Ltd.
List 4
Adapalene 0.1%, Benzoyl
Peroxide 2.5%)
Atazanavir (as sulfate)
equivalent to Atazanavir
300mg, Ritonavir USP
100mg per film coated tablet
Each enteric coated tablet
contains Esomeprazole
Magnesium Trihydrate
equivalent to Esomeprazole
to 20mg
Each enteric coated tablet
contains Esomeprazole
Magnesium Trihydrate
equivalent to Esomeprazole
to 40mg
Digoxin, B.P., 125mcg
Cari-Med Ltd.
CLASSIFICATION
STATUS
Dermatologic Agent
List 4
Recharged
Distributors
Limited
Anti-Retroviral
Agent (ARV)
List 4
Ind-Swift Limited,
India
Indies Pharma
Jamaica Limited
Proton Pump
Inhibitor (PPI)
List 4
Ind-Swift Limited,
India
Indies Pharma
Jamaica Limited
Proton Pump
Inhibitor (PPI)
List 4
M/S. Unicure
Remedies Pvt. Ltd.,
Baroda, India
Health Brands Ltd.
Cardiac Glycoside
List 4
DRUGS REGISTERED IN OCTOBER 2013
REQUIREMENTS
FOR USE
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
Novartis
Farmacéutica S.A.,
Barcelona, Spain
Powder
Manufacturer:
Wyeth Farma S.A.,
Spain; Manufacturer
of solvent/ diluent:
Vetter PharmaFertigung GmbH &
Co KG., Germany
Powder
Manufacturer:
Wyeth Farma S.A.,
Spain; Manufacturer
of solvent/ diluent:
Vetter PharmaFertigung GmbH &
Co KG., Germany
Genpharma
International Pvt.
Ltd., India
Cari-med Limited
Anti-hypertensive
Agent
List 4
24-10-13
Diovan 320mg
Tablets
Valsartan 320mg
30-10-13
Benefix 250 IU
powder and solvent
for solution for
injection – IV use
Each vial contains 250IU
nonacog alfa {recombinant
coagulation factor IX}; 1 vial
+ 1 prefilled syringe + 1
injection set
30-10-13
Benefix 500 IU
powder and solvent
for solution for
injection – IV use.
Each vial contains 500IU
nonacog alfa {recombinant
coagulation factor IX}; 1 vial
+ 1 prefilled syringe + 1
injection set
30-10-13
Irlara 35mg modified
release film-coated
tablets.
Trimetazidine
dihydrochloride BP 35mg
H.D. Hopwood
List 4
H.D. Hopwood
List 4
Medical Products
Limited
DRUGS REGISTERED IN NOVEMBER 2013
Anti-anginal Agent
List 4
REQUIREMENTS
FOR USE
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
For M/S. Cipla Ltd.,
Maharashtra, India
by M/S. Mistair
Health & Hygiene
Ltd., Kolhapur,
India
M/S. Cipla Ltd.,
Verna, Goa, India
Lasco Distributors
Ltd.
Anthelmintic Agent
List 2
Lasco Distributors
Ltd.
Analgesic Agent
(Rub)
List 2
Orion Sales Limited,
Delisser Avenue,
Yallas, St. Thomas
M/S. MSN
Laboratories Ltd.,
Bollaram, India
M/S. MSN
Laboratories Ltd.,
Bollaram, India
M/S. Cipla Ltd.,
Bhiwandi, India, by
M/S. Vardhaman
Remedies Pvt. Ltd.,
Maharashtra, India
Orion Sales
Limited
Dermatologic Agent
List 2
12-11-13
Prantel Suspension
Each 1 ml contains: Pyrantel
embonate Ph. Eur., 14.4mg
equivalent to Pyrantel 5mg;
Febantel, 15mg
12-11-13
Cofenac Gel
26-11-13
KomeFast Super
Toning Cream
Diclofenac diethylamine,
B.P., 1.16% w/w equivalent
to Diclofenac sodium, B.P.,
1% w/w
Hydroquinone 1.9%
12-11-13
Febuday 80 Tablets
Febuxostat 80mg
12-11-13
Febuday 40 Tablets
Febuxostat 40mg
12-11-13
Otibact Ear Drops
Each 1ml contains:
enrofloxacin 5mg; silver
sulfadiazine, U.S.P., 10mg
Lasco Distributors
Limited
List 4
Lasco Distributors
Limited
List 4
Lasco Distributors
Limited
DRUGS REGISTERED IN NOVEMBER 2013
Anti-biotic
List 4
REQUIREMENTS
FOR USE
For Veterinary
Use Only
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
13-11-13
Pantonex DR-20
Delayed-Release
Tablets
Pantonex DR-40
Delayed-Release
Tablets
Simvastatin Tablets
10mg
Pantoprazole sodium
sesquihydrate EP equivalent
to pantoprazole 20mg
Pantoprazole sodium
sesquihydrate EP equivalent
to pantoprazole 40mg
Simvastatin EP 10mg
IPCA Laboratories
Ltd., Silvassa, India
Servi-Care
Distributors Ltd.
Proton Pump
Inhibitor (PPI)
List 4
IPCA Laboratories
Ltd., Silvassa, India
Servi-Care
Distributors Ltd.
Proton Pump
Inhibitor (PPI)
List 4
Jubilant Life
Sciences Ltd.,
Uttarakhand, India
Jubilant Life
Sciences Ltd.,
Uttarakhand, India
Jubilant Life
Sciences Ltd.,
Uttarakhand, India
Jubilant Life
Sciences Ltd.,
Uttarakhand, India
Jubilant Life
Sciences Ltd.,
Uttarakhand, India
Jubilant Life
Sciences Ltd.,
Uttarakhand, India
Medical Products
Ltd.
List 4
Medical Products
Ltd.
AntiHypercholesterolemic
Agent
AntiHypercholesterolemic
Agent
Anti-hypertensive
Agent
Medical Products
Ltd.
Anti-hypertensive
Agent
List 4
Medical Products
Ltd.
Anti-hypertensive
Agent
List 4
Medical Products
Ltd.
Anti-hypertensive
Agent
List 4
13-11-13
13-11-13
13-11-13
Simvastatin Tablets
20mg
Simvastatin EP 20mg
13-11-13
Losartan Potassium
Tablets 25mg
Losartan potassium Ph. Eur.
25mg
13-11-13
Losartan Potassium
Tablets 50mg
Losartan potassium Ph. Eur.
50mg
13-11-13
Valtan-80 Tablets
Valsartan Ph. Eur. 80mg
13-11-13
Valtan-320 Tablets
Valsartan Ph. Eur. 320mg
LOCAL AGENT
Medical Products
Ltd.
CLASSIFICATION
DRUGS REGISTERED IN NOVEMBER 2013
STATUS
List 4
List 4
REQUIREMENTS
FOR USE
DATE
PRODUCT
GENERIC DESIGNATION
14-11-13
Pleniva-20 GastroResistant Tablets
14-11-13
Pleniva-40 GastroResistant Tablets
Pantoprazole sodium
sesquihydrate Ph. Eur.
equivalent to pantoprazole
20mg
Pantoprazole sodium
sesquihydrate Ph. Eur.
equivalent to pantoprazole
40mg
Each 1ml contains 22.3mg
(2%) Dorzolamide
hydrochloride equivalent to
Dorzolamide 20mg
Each 1ml contains 22.26mg
(2%) Dorzolamide
hydrochloride equivalent to
Dorzolamide 20mg Timolol
maleate 6.83% (0.59%)
equivalent to 5mg Timolol
Each 1ml contains
Latanoprost 50mcg
13-11-13
Dorzopt Eye Drops
Solution
13-11-13
Dorzotim Eye Drops
Solution
15-11-13
Latanopt 0.005%
Sterile Eye Drops
15-11-13
Simvast 10mg
Tablets
Simvastatin Ph. Eur. 10mg
15-11-13
Simvast 20mg
Tablets
Simvastatin Ph. Eur. 20mg
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
Jubilant Life Sciences
Ltd., Uttarakhand, India
Medical Products Proton Pump Inhibitor
Ltd.
(PPI)
List 4
Jubilant Life Sciences
Ltd., Uttarakhand, India
Medical Products Proton Pump Inhibitor
Ltd.
(PPI)
List 4
M/S. Indoco Remedies
Ltd., Verna, Goa, India
Indies Pharma Ja.
Ltd.
Anti-glaucoma Agent
List 4
M/S. Indoco Remedies
Ltd., Verna, Goa, India
Indies Pharma Ja.
Ltd.
Anti-glaucoma Agent
List 4
M/S. Indoco Remedies
Ltd., Verna, Goa, India
Indies Pharma Ja.
Ltd.
Anti-glaucoma
Agent/Intra-ocular
Hypertension
M/S. Indoco Remedies
Indies Pharma Ja. AntiLtd., Verna, Goa, India
Ltd.
Hypercholesterolemic
Agent
M/S. Indoco Remedies
Indies Pharma Ja. Anti-Hyperlipidemic
Ltd., Verna, Goa, India
Ltd.
Agent
DRUGS REGISTERED IN NOVEMBER 2013
List 4
List 4
List 4
REQUIREMENT
S FOR USE
DATE
PRODUCT
15-11-13
Simvast 40mg
Tablets
12-11-13
LH 5000 (Softec III)
Posterior Chamber
Intraocular Lens
Biograst Injection
300mcg in a Prefilled Syringe;
Biograst Injection
300mcg in a Prefilled Syringe;
21-11-13
21-11-13
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
Simvastatin Ph. Eur. 40mg
M/S. Indoco
Remedies Ltd.,
Verna, Goa, India
Lenstec (Barbados)
Inc., Christ Church,
Barbados
Beijing Four
Pharmaceutical Co.
Ltd., Beijing City,
China
Indies Pharma Ja.
Ltd.
AntiHypercholesterolemic
Agent
List 4
Recombinant Human
Granulocyte Colony
Recombinant Human
Granulocyte Colony
21-11-13
Complera
200mg/25mg/300mg
Tablets
Des’ Air Tablets
Emtricitabine 200mg;
rilpivirine 25mg; tenofovir
disoproxil fumarate 300mg
Desloratadine INN 5mg
21-11-13
Des’ Air Syrup
Desloratadine INN
25mg/5ml
Patheon Inc.,
Mississauga,
Canada
Incepta
Pharmaceuticals
Ltd., Dhaka,
Bangladesh
Incepta
Pharmaceuticals
Ltd., Dhaka,
Bangladesh
Clear Horizon Ltd.
List 4
Indies Pharma Ja.
Ltd
List 4
H.D. Hopwood
Anti-Retroviral Agent
(ARV)
List 4
Indies Pharma Ja.
Ltd.
Histamine Blocker
List 4
Indies Pharma Ja.
Ltd.
Histamine Blocker
List 4
DRUGS REGISTERED IN NOVEMBER 2013
REQUIREMENTS
FOR USE
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
Incepta
Pharmaceuticals
Ltd., Dhaka,
Bangladesh
Incepta
Pharmaceuticals
Ltd., Dhaka,
Bangladesh
Incepta
Pharmaceuticals
Ltd., Dhaka,
Bangladesh
Incepta
Pharmaceuticals
Ltd., Dhaka,
Bangladesh
Incepta
Pharmaceuticals
Ltd., Dhaka,
Bangladesh
Popular
Pharmaceuticals
Ltd., Dhaka,
Bangladesh
Indies Pharma Ja.
Ltd.
Immunosuppressant
List 4
Indies Pharma Ja.
Ltd.
Topical Anti-biotic
List 4
Indies Pharma Ja.
Ltd.
Respiratory Agent
List 4
Indies Pharma Ja.
Ltd.
Respiratory Agent
List 4
Indies Pharma Ja.
Ltd.
Dermatological Agent
List 4
Indies Pharma Ja.
Ltd.
Anti-hypertensive
Agent
List 4
22-11-13
Biosporine oral
solution
Cyclosporine U.S.P.,
100mg/1ml
22-11-13
Fusitop – H Cream
22-11-13
Budison Nebules
Nebuliser
Suspension 1mg/2ml
Each 1gm contains: Fusidic
Acid, B.P., 20mg;
Hydrocortisone acetate,
B.P., 10mg
Each 2ml ampoule conatins
Budesonide B.P., 1mg
22-11-13
Budinase Nasal
Spray, 120 metered
sprays
Each actuation delivers
budesonide, B.P., 100mcg
22-11-13
Curinac 0.1% Cream
Adapalene INN 1mg per
gram
25-11-13
Amloval 5/160
Tablets
Amlodipine besilate, B.P.,
equivalent to Amlodipine
5mg; Valsartan, U.S.P.,
160mg
DRUGS REGISTERED IN NOVEMBER 2013
STATUS
REQUIREMENTS
FOR USE
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
Popular
Pharmaceuticals
Ltd., Dhaka,
Bangladesh
IND-Swift Ltd.,
Samba (Jammu),
India
IND-Swift Ltd.,
Samba (Jammu),
India
Janssen Ortho LLC,
Gurabo, Puerto Rico
Indies Pharma Ja.
Ltd.
Anti-hypertensive
Agent
List 4
Indies Pharma Ja.
Ltd.
Anti-Hyperglycaemic
Agent
List 4
Indies Pharma Ja.
Ltd.
Anti-Hyperglycaemic
Agent
List 4
Cari-Med Limited
Anti-Retroviral Agent
(ARV)
List 4
Incepta
Pharmaceuticals
Ltd., Bangladesh
Indies Pharma Ja.
Ltd.
Proton Pump
Inhibitor (PPI)
List 4
Incepta
Pharmaceuticals
Ltd., Bangladesh
Indies Pharma Ja.
Ltd.
Proton Pump
Inhibitor (PPI)
List 4
25-11-13
Amloval 10/160
Tablets
25-11-13
Acarbay 25 Tablets
Amlodipine besilate, B.P.,
equivalent to
Amlodipine 10mg;
Valsartan, U.S.P., 160mg
Acarbose, B.P., 25mg
25-11-13
Acarbay 50 Tablets
Acarbose, B.P., 50mg
26-11-13
Prezista 800mg film
coated tablets
26-11-13
Pantosec 20mg
tablets
26-11-13
Pantosec 40mg
tablets
27-11-13
Biocaltrol 0.25
Capsules
Darunavir ethanolate
867.28mg corresponding
to 800mg Darunavir
Each tablet contains
Pantoprazole sodium
sesqui- hydrate USP
22.55mg equivalent to
Pantoprazole 20mg
Each tablet contains
Pantoprazole sodium
sesqui- hydrate USP 45.1mg
equivalent to Pantoprazole
40mg
Calcitriol, B.P., 0.25mcg
CLASSIFICATION
Incepta
Indies Pharma Ja.
Pharmaceuticals
Ltd.
Ltd., Bangladesh
DRUGS REGISTERED IN NOVEMBER 2013
STATUS
List 4
REQUIREMENTS
FOR USE
DATE
27-11-13
28-11-12
PRODUCT
Biopofol Emulsion
for IV
Administration
Venalon 500 Tablets
22-11-13
Softec HD Posterior
Chamber Intraocular
Lens
22-11-13
Softec 1 Posterior
Chamber Intraocular
Lens
GENERIC DESIGNATION
MANUFACTURER
Each 20ml vial contains
propofol, B.P., 200mg
Popular Infusions
Ltd., Tongi,
Bangladesh
Incepta
Pharmaceuticals
Ltd., Bangladesh
Lenstec (Barbados)
Inc., Christ Church,
Barbados
Indies Pharma Ja.
Ltd
General Anaesthetic
List 4
Indies Pharma Ja.
Ltd
Venotropic Agent
List 4
Clear Horizon Ltd.
List 4
Lenstec (Barbados)
Inc., Christ Church,
Barbados
Clear Horizon Ltd.
List 4
Each tablet contains
Diosmin (micronized) BP
450mg; Hesperidin BP 50mg
Ethoxy 2 Hydrox Benzo 1%,
Azo Iso Butyronitrile 0.11%,
Ethylene Glyco
Dimethacrylate0.42%, 2Hydroxy Ethyl
Methacrylate 85.58%,
Methyl Methacrylate 14%
Acryloxy Ethoxy 2 Hydrox
Benzo 1%, Azo Iso
Butyronitrile 0.11%,
Ethylene Glyco
Dimethacrylate0.42%, 2Hydroxy Ethyl
Methacrylate 85.58%,
Methyl Methacrylate 14%
LOCAL AGENT
CLASSIFICATION
DRUGS REGISTERED IN DECEMBER 2013
STATUS
REQUIREMENTS
FOR USE
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
3-12-13
Barzithro 500 Tablets
Azithromycin 500mg USP
Supreme
Chemicals Limited
3-12-13
Cozaar XQ 5/100mg
Tablets
Amlodipine camsylate
7.84mg; Losartan
potassium100mg
3-12-13
Cozaar XQ 5/50mg
Tablets
Amlodipine camsylate
7.84mg; Losartan
potassium50mg
Flamingo
Pharmaceuticals
Ltd., India
Hanmi Pharma Co.
Ltd., (Paltan site),
Gyeonggi-do,
Republic of Korea
(manufacturer
Hanmi Pharma Co.
Ltd., (Paltan site),
Gyeonggi-do,
Republic of Korea
(manufacturer
Marksans Pharma
Ltd., India
5-12-13
5-12-13
5-12-13
10-12-13
11-12-13
Health 2000
Alpramark 0.25mg
Tablets
Health 2000
Alpramark 0.50mg
Tablets
Mycon Oral Gel 2%
w/w
Bronculair 10mg
Tablets
Baramlo 5 Tablets
Alprazolam EP 0.25mg
Alprazolam EP 0.50mg
Marksans Pharma
Ltd., India
CLASSIFICATION
Anti-biotic
STATUS
List 4
Health Brands
Limited
Anti-hypertensive
Agent
List 4
Health Brands
Limited
Anti-hypertensive
Agent
List 4
Health Brands
Limited
Anti-anxiety Agent
List 4
Health Brands
Limited
Anti-anxiety Agent
List 4
Miconazole BP 2% w/w
Aristopharma Ltd., R.A. Williams
Anti-fungal Agent
{miconazole 20mg per gram
Bangladesh
Distributors
Montelukast sodium 10.4mg
Marksans Pharma Health Brands
Respiratory
equivalent to
Ltd., India
Limited
Agent/Leukotriene
Montelukast IH 10mg
Receptor Antagonist
Amlodipine besilate 6.93mg Flamingo
Supreme
Anti-hypertensive
equivalent to Amlodipine
Pharmaceuticals
Chemicals Limited Agent
BP 5mg
Limited, India
DRUGS REGISTERED IN DECEMBER 2013
List 4
List 4
List 4
REQUIREMENTS
FOR USE
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
Amlodipine besilate
13.87mg equivalent to
Amlodipine BP 10mg
Sevelamer carbonate 800mg
Flamingo
Pharmaceuticals
Limited, India
Genzyme Ireland
Ltd., Waterford,
Ireland
Cilag AG,
Switzerland
11-12-13
Baramlo 10 Tablets
11-12-13
Renvela 800mg FilmCoated Tablets
12-12-13
Stelara 45mg/0.5ml
Ustekinumab 45mg/0.5ml
Solution for injection
in pre-filled syringe –
for SC use.
Fusidate H Cream
Fusidic acid 2%,
hydrocortisone acetate BP
1%
Barfurox 250mg
Cefuroxime axetil USP
Tablets
315mg equivalent to
cefuroxime 250mg
13-12-13
13-12-13
LOCAL AGENT
CLASSIFICATION
STATUS
Supreme
Chemicals Limited
Anti-hypertensive
Agent
List 4
H.D. Hopwood
Phosphate binding
Agent
List 4
Cari-Med Limited
Human monoclonal
anti-body
List 4
Aristopharma
R.A. Williams
Limited, Bangladesh Distributors Ltd.,
Anti-biotic
List 4
Flamingo
Pharmaceuticals
Ltd., India
Anti-biotic
List 4
Supreme
Chemicals Limited
REQUIREMENTS
FOR USE
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