DATE
PRODUCT
DRUGS REGISTERED IN JANUARY 2014
+
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
21-01-14 Caponko 500 Tablets
Capecitabine USP 500mg
Reliance Life Sciences PVT Ltd
India
T. Geddes Grant
Distributors Limited
List 4
22-01-14 Montelukast Sandoz 10mg
Film Coated Tablets
Montelukast Sodium 10.4mg
equivalent to 10mg Montelukast
Sandoz Ilac Sanayi Ve Ticaret
A.S., Turkey
Qualcare Limited
List 4
22-01-14 Montelukast Sandoz 5mg
Chewable Tablets
Montelukast Sodium 5.20mg
equivalent to 5mg Montelukast
Sandoz Ilac Sanayi Ve Ticaret
A.S., Turkey
Qualcare Limited
List 4
22-01-14 Montelukast Sandoz 4mg
Chewable Tablets
Montelukast Sodium 4.16mg
equivalent to 4mg Montelukast
Sandoz Ilac Sanayi Ve Ticaret
A.S., Turkey
Qualcare Limited
List 4
29-01-14 Apo-Letrozole 2.5mg Tablets
letrozole USP
Apotex Inc., Canada
Cari-Med Limited
List 4
31-01-14 Health 2000 Dispersible
Aciclovir 400mg Tablets
aciclovir BP 400mg
Unicure Remedies Pvt. Ltd.,
India
Health Brands Limited
List 4
31-01-14 Flexilor 4 Tablets
Lornoxicam 4mg tablets
Glenmark Pharmaceuticals Ltd.,
India
T. Geddes Grant
Limited
List 4
DATE
PRODUCT
31-01-14 Flagasolina Injection for
IM/IV use
31-01-14 C-Tri T 250 Tablets
GENERIC DESIGNATION
MANUFACTURER
hydralazine hydrochloride USP
20mg/ml Injection
Flagship Biotech
International, Thane,
Maharashtra, India
Unimed Limited
List 4
Emcure Pharmaceuticals
Ltd., Pune, Maharashtra,
India
Medical Products
List 4
Cefuroxime axetil tablets USP
equivalent to cefuroxime 250mg
LOCAL AGENT
STATUS
31-01-14 C-Tri T 500 Tablets
Cefuroxime axetil tablets USP
equivalent to cefuroxime 500mg
Emcure Pharmaceuticals
Ltd., Pune, Maharashtra,
India
Medical Products
List 4
31-01-14 Acem 500 Tablets
Clarithromycin tablets USP 500mg
Emcure Pharmaceuticals
Ltd., Pune, Maharashtra,
India
Medical Products
List 4
DRUGS REGISTERED IN JANUARY 2014
DATE
PRODUCT
31-01-14 Acem 250 Tablets
GENERIC DESIGNATION
Clarithromycin tablets USP 250mg
MANUFACTURER
Emcure Pharmaceuticals Ltd.,
Pune, Maharashtra, India
LOCAL AGENT
Medical Products
STATUS
List 4
DRUGS REGISTERED IN FEBRUARY 2014
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
10-02-14
Eliquis 2.5mg Film-coated Tablets
Apixaban 2.5mg
H.D. Hopwood,
List 4
10-02-14
Eliquis 5mg Film-coated Tablets
Apixaban 5mg
H.D. Hopwood
List 4
13-02-14
Esoz Inj. 40mg Powder for
Solution for IV use only
T. Geddes Grant
Limited
List 4
13-02-14
Acinject-500 Injection for IM/IV
use
esomeprazole sodium IH
equivalent to esomeprazole
40mg
amikacin sulphate USP 500mg
injection
Uni-med Limited
List 4
13-02-14
Lizolid Injection 200mg/100ml for
IV use only
Bristol-Myers Squibb
Manufactruing Company,
Humacao, Puerto Rico,
USA
Bristol-Myers Squibb
Manufactruing Company,
Humacao, Puerto Rico,
USA
Glenmark Pharmaceuticals
Limited, Kabilpur, Navsari,
Gujarat, India
Flagship Biotech
International, Thane,
Maharashtra, India
Glenmark Pharmaceuticals
Limited, Kheda, Gujarat,
India
T. Geddes Grant
Limited,
List 4
13-02-14
Zytop Injection 100mg/5ml for
Intravenous use
Uni-med Limited,
List 4
Linezolid 200mg injection,
dextrose monohydrate USP
equivalent to dextrose
anhydrous 5% w/v water for
injection USP q.s
etoposide USP 100mg/5ml
Flagship Biotech
International,Solon,
Himachal, Pradesh, India
DRUGS REGISTERED IN FEBRUARY 2014
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
13-02-14 Z-Cita-1GM Powder gemcitabine hydrochloride USP equivalent to
for reconstitution for gemcitabine 1g
Intravenous
Infusion
Flagship Biotech
International, Solan,
Himachal, Pradesh, India
Uni-med Limited
List 4
13-02-14 Z-Cita-200mg
Powder for
reconstitution for
Intravenous
Infusion
10-02-14 Norgesic Tablets
gemcitabine hydrochloride USP equivalent to
gemcitabine 200mg
Flagship Biotech
International, Solan,
Himachal, Pradesh, India
Uni-med Limited
List 4
Paracetamol/orphenadrine citrate 450mg/35mg
Quimica Y Farmacia, S.A. de
C.V., Ramos Arizpe,
Coahuila, Mexico
Cari-Med
Limited
List 4
13-02-14 Flagtin 50mg/50ml
Injection for
Intravenous
Infusion
cisplatin BP 50mg/50ml injection
Flagship Biotech
International, Himachal,
Pradesh, India
Uni-med Limited
List 4
DRUGS REGISTERED IN FEBRUARY 2014
STATUS
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
12-02-14 Fusifen Cream 2%
w/w
fusidic acid BP
Fourrts (India) Laboratories Pvt. Ltd
Inter-Commercial
Distributors Ltd
List 4
17-02-14 Eylia 40mg/ml
Solution for
Intravitreal
18-02-14 Momate 50mcg
Nasal Spray – 60
metered doses
Injection – Vial, (aflibercept)
Regeneron Pharmaceuticals Inc, USA
Lasco Distributors
Limited
List 4
each spray delivers mometasone furoate
monohydrate equivalent to mometasone
furoate 50mcg
Glenmark Pharmaceuticals Ltd., India
T. Geddes Grant
Distributors Ltd
List 4
19-02-14 Pemehope 100mg
Sterile Lyophilized
Powder for
constitution for IV
Injection
10-02-14 Oxuba 50mg Sterile
Lyophilized
Powder for
constitution for
Intravenous use
only
pemetrexed disodium equivalent to
pemetrexed 100mg
Glenmark Generics SA, Buenos Aires,
Argentina
T. Geddes Grant
Distributors Ltd.,
List 4
oxaliplatin 50mg ph Eur
Glenmark Generics SA, Buenos Aires,
Argentina
T. Geddes Grant
Distributors Ltd
List 4
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
19-02-14 Jakavi 5mg Tablets
Ruxolitinib phosphate 6.6mg
equivalent to ruxolitinib 5mg
Novartis Pharma Stein AG, Stein,
Switzerland
Cari-Med Limited
List 4
19-02-14 Jakavi 15mg Tablets
Ruxolitinib phosphate 19.8mg
equivalent to ruxolitinib 15mg
Novartis Pharma Stein AG, Stein,
Switzerland
Cari-Med Limited
List 4
19-02-14 Jakavi 20mg Tablets
Ruxolitinib phosphate 26.4mg
equivalent to
ruxolitinib 20mg
Novartis Pharma Stein AG, Stein,
Switzerland
Cari-Med Limited
List 4
26-02-14 Signifor Solution for
Injection 0.3mg/1ml
for Subcutaneous use
only
Pasireotide diaspartate 0.38mg
equivalent to pasireotide 0.3mg
Novartis Pharma Stein AG, Stein,
Switzerland
Cari-Med Limited
List 4
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
26-02-14 Signifor Solution
for Injection
0.9mg/1ml for
Subcutaneous
use only
Pasireotide diaspartate 1.13mg equivalent to
pasireotide 0.9mg
Novartis Pharma Stein AG,
Stein, Switzerland
Cari-Med Limited
List 4
26-02-14 Signifor Solution
for Injection
0.6mg/1ml for
Subcutaneous
use only
Pasireotide diaspartate 0.75mg equivalent to
pasireotide 0.6mg
Novartis Pharma Stein AG,
Stein, Switzerland
Cari-Med Limited
List 4
26-02-14 Zupivac H
Injection
5mg/5ml
Bupivacaine HCl BP equivalent to anhydrous
Bupivacaine HCl 5mg, dextrose (monohydrate)
USP 80mg, water for injection USP q.s. (per
ml)
Flagship Biotech International,
Solon, Himachal, Pradesh,
India
Uni-med Limited,
List 4
DRUGS REGISTERED IN MARCH 2014
DATE
PRODUCT
GENERIC
DESIGNATION
MANUFACTURER
LOCAL
AGENT
STATUS
4-03-14 Esem 2.5 Tablets
S-Amlodipine besylate
equivalent to samlodipine 2.5mg
MSN Laboratories Ltd.,
India
Lasco
Distributors Ltd
List 4
4-03-14 Nificard 30 Extended Release
Tablets
nifedipine USP 30mg
Unique Pharmaceuticals
Laboratories, India
Medical
Products
Limited
List 4
4-03-14 Esem 5 Tablets
S-Amlodipine besylate
equivalent to samlodipine 5mg
MSN Laboratories Ltd.,
India
Lasco
Distributors Ltd
List 4
Each box contains 1
capsule of 125mg
aprepitant and 2
capsules of 80mg
aprepitant
Capecitabine 500mg USP
Alkermes Pharma
Ireland Limited
10-03-14 Emend 125mg/80mg Capsules
12-03-14 Flagoda 500mg Tablets
Flagship Biotech
International, India
List 4
Uni-Med
HealthCare
Limited
List 4
DATE PRODUCT
11-03-14 Candesartan
Cilexetil/Hydrochlorothiazide
Sandoz 8mg/12.5mg tablets
11-03-14 Candesartan
Cilexetil/Hydrochlorothiazide
Sandoz 16mg/12.5mg tablets
11-03-14 Candesartan
Cilexetil/Hydrochlorothiazide
Sandoz 32mg/25mg tablets
11-03-14 Biosulin R 100 IU/ml Injection;
S.C/IV use only 10ml vials
11-03-14 Biosulin N 100 IU/ml Injection; S.C
use only 10ml vials
GENERIC
DESIGNATION
MANUFACTURER
LOCAL
AGENT
STATUS
Each tablet contains
candesartan cilexetil 8mg
hydrochlorothiazide
12.5mg
Each tablet contains
candesartan
cilexetil16mg
hydrochlorothiazide
12.5mg
Each tablet contains
candesartan cilexetil
32mg
hydrochlorothiazide
25mg
Lek Pharmaceuticals
d.d., Slovenia
Qualcare
Limited
List 4
Lek Pharmaceuticals
d.d., Slovenia
Qualcare
Limited
List 4
Lek Pharmaceuticals
d.d., Slovenia
Qualcare
Limited
List 4
Each 1ml solution
contains: 100 U Insulin
Human USP
(recombinant DNA
Origin)
Each 1ml solution
contains: 100 IU Insulin
Human USP
(recombinant DNA
Origin)}
Popular Pharmaceuticals
Ltd., Tongi, Gazipur,
Bangladesh
Indies Pharma
Ja. Ltd
List 4
Popular Pharmaceuticals
Ltd., Tongi, Gazipur,
Bangladesh
Indies Pharma
Ja. Ltd
List 4
DATE
PRODUCT
12-03-14
Ribomustin 100mg
powder for
concentrate for
solution for
infusion-vial for IV
injection
Ramlon 5mg/5mg
Hard Capsules
12-03-14
GENERIC
DESIGNATION
Bendamustine
hydrochloride 100mg
Ramipril 5mg;
amlodipine besilate
5mg
12-03-14
Ramlon 10mg/5mg
Hard Capsules
Ramipril 10mg;
amlodipine besilate
5mg
12-03-14
Ramlon
10mg/10mg Hard
Capsules
Ramipril 10mg;
amlodipine besilate
10mg
13-03-14
Fempro 2.5mg
Tablets
Momate 50mcg
nasal spray – 120
metered dose
Letrozole USP 2.5mg
13-03-14
mometasone furoate
monohydrate
equivalent to
mometasone furoate
0.05% w/w; 50mcg per
spray
DRUGS REGISTERED IN MARCH 2014
MANUFACTURER
LOCAL AGENT
CLASSIFICATION
STATUS
Oncotec Pharma
Producktion GmbH,
Germany
Cari-Med Limited
List 4
Egis Pharmaceuticals PLC,
H-1165 Budapest,
Bokenyfeldi ut 118-120,
Hungary
Egis Pharmaceuticals PLC,
H-1165 Budapest,
Bokenyfeldi ut 118-120,
Hungary
Egis Pharmaceuticals PLC,
H-1165 Budapest,
Bokenyfeldi ut 118-120,
Hungary
Cipla Ltd., India
Medimpex Jamaica
Ltd
List 4
Medimpex Jamaica
Ltd
List 4
Medimpex Jamaica
Ltd
List 4
Lasco Distributors
Ltd
T. Geddes Grant
Distributors Ltd
List 4
Glenmark Pharmaceuticals
Ltd., India
List 4
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
13-03-14
Zaart-25 Tablets
losartan potassium, USP,
25mg
M/S Cipla Ltd., Solan, India
Lasco Distributors Ltd
List 4
13-03-14
Zaart-50 Tablets
losartan potassium, USP,
50mg
M/S Cipla Ltd., Solan, India
Lasco Distributors Ltd
List 4
13-03-14
Scheriproct N Rectal
Cream
1gm contains: fluocortolone
pivalate, 1mg hidocaine Hcl
20mg
Intendis manufacturing, SpA,
Milano, Italy
Lasco Distributors Ltd
List 4
14-03-14
Calutide 50 Tablets
bicalutamide USP 50mg
Cipla Limited, India
Lasco Distributors Ltd
List 4
14-03-14
Simcard 40mg Tablets
Simvastatin USP 40mg
Cipla Limited, India
Lasco Distributors Ltd
List 4
15-03-14
Prednicort Oral Solution
Prednisolone sodium
phosphate, U.S.P., 5mg/5ml
Incepta Pharmaceuticals Ltd.,
Dhaka, Bangladesh
Indies Pharma Ja. Ltd
List 4
DRUGS REGISTERED IN MARCH 2014
DATE
PRODUCT
11-03-14
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
Biosulin M 30/70
100 IU/ml
Injection; S.C use
only; 10ml vials
{Each 1ml
suspension
contains
12-03-14 Health 2000
Meloxicam Tablets
B.P. 15mg
12-03-14 TaDa Tablets
100 IU Insulin Human USP
(recombinant DNA Origin
} as, 70% Human Isulin Isophane
suspension & 30% Human Insulin
Regular Solution
Popular Pharmaceuticals Ltd.,
Tongi, Gazipur, Bangladesh
Indies Pharma Ja. Ltd.,
List 4
Meloxicam , B.P., 15mg
M/S Brussels Laboratories Pvt.
Ltd., Gujarat, India
Health Brands Limited
List 4
Tadalafil 20mg
Health Brands Limited
List 4
25.03.13 Ribomustin 25mg
powder for
concentrate for
solution for
infusion-vial for IV
injection
Bendamustine hydrochloride 25mg
M/S Unicure Remedies Pvt. Ltd.,
Baroda, India
Oncotec Pharma Producktion
GmbH, Germany
Cari-Med Limited
List 4
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
15-03-14
Cortinase Nasal Spray
Each actuation delivers
triamcinolone acetonide B.P.,
55 micrograms
Incepta Pharmaceuticals Ltd.,
Dhaka, Bangladesh
Indies Pharma Ja. Ltd
List 4
15-03-14
Flutinase Nasal Spray
Each spray delivers
fluticasone propionate, B.P
50mcg
Incepta Pharmaceuticals Ltd.,
Dhaka, Bangladesh
Indies Pharma Ja. Ltd
List 4
17-03-14
Tolucombi 40mg/12.5mg
Tablets
Telmisartan 40mg,
hydrochlorothiazide 12.5mg
KRKA d.d. Novo Mesto, Slovenia
Servi-Care Distributors
Limited
List 4
15-03-14
Azenase Nasal Spray, 120
metered sprays
Each actuation delivers
azelastine hydrochloride B.P.,
137mcg
Incepta Pharmaceuticals Ltd.,
Dhaka, Bangladesh
Indies Pharma Ja. Ltd
List 4
17-03-14
Tolucombi 80mg/25mg
Tablets
Telmisartan 80mg,
hydrochlorothiazide 25mg
KRKA d.d. Novo Mesto, Slovenia
Servi-Care Distributors
Limited
List 4
15-03-14
Health 2000
Pentoxifylline Extended
Release 400mg Tablets
pentoxifylline USP 400mg
Brussels Laboratories Pvt. Ltd.,
India
Health Brands Limited
List 4
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
18-03-14
Domstop Paediatric
Drops
Incepta Pharmaceuticals Ltd.,
Dhaka, Bangladesh
Indies Pharma Ja. Ltd.,
List 4
18-03-14
Incepta Pharmaceuticals Ltd.,
Dhaka, Bangladesh
Indies Pharma Ja. Ltd.,
List 4
19-03-14
Bioprist-Inj. Vit K
Adult; Ampoules;
IM/IV/Oral Only.
Intelence 25mg Tablets
Each 1ml suspension
contains: domperidone, B.P
5mg
1ml ampoule conatins:
phytomenadione, B.P.,
10mg
Etravirine
Janssen-Cilag SpA, Italy
Cari-Med Limited
List 4
27-03-14
Filstat 10 Tablets
Fourrts (India) Laboratories Pvt.
Limited
Inter-Commercial
Distributors Ltd
List 4
27-03-14
Filstat 20 Tablets
Fourrts (India) Laboratories Pvt.
Limited
Inter-Commercial
Distributors Ltd
List 4
21-03-14
Filstat 40 Tablets
Fourrts (India) Laboratories Pvt.
Limited
Inter-Commercial
Distributors Ltd
List 4
26-03-14
Filstat 80 Tablets
Atorvastatin calcium
trihydrate BP 10.84mg
equivalent to atorvastatin
10mg
Atorvastatin calcium
trihydrate BP 21.68mg
equivalent to atorvastatin
20mg
Atorvastatin calcium
trihydrate BP 43.36mg
equivalent to atorvastatin
40mg
Atorvastatin calcium
trihydrate BP 86.72mg
equivalent to atorvastatin
80mg
Fourrts (India) Laboratories Pvt.
Limited
List 4
DRUGS REGISTERED IN APRIL 2014
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
15-04-14
Lanzul 30mg GastroResistant Capsules
Lansoprazole 30mg
KrKA, d.d., Novo Mesto,
Slovenia
Servi-Care Distributors
Limited
List 4
15-04-14
Ciprinol 500mg FilmCoated Tablets
Ciprofloxacin hydrochloride
monohydrate 582mg Ph. Eur.
equivalent to ciprofloxacin
500mg
KrKA, d.d., Novo Mesto,
Slovenia
Servi-Care Distributors
Limited
List 4
3-04-14
Carboplatin Injection BP
50mg/5ml for IV infusion
carboplatin BP 10mg/ml
Naprod Life Sciences Pvt.
Ltd., Boisar, Thane,
Maharashtra, India
Inter-Commercial
Distributors Ltd
List 4
3-04-14
Carboplatin Injection BP
450mg/45ml
carboplatin BP 10mg/ml
Naprod Life Sciences Pvt.
Ltd., Boisar, Thane,
Maharashtra, India
Inter-Commercial
Distributors Ltd
List 4
DATE
PRODUCT
GENERIC DESIGNATION
3-04-14
Oxuba 100mg Sterile
Lyophylized Powder for
Reconstition for IV use
only
Oxaliplatin 100mg Ph Eur
3-04-14
Pemehope 500mg Sterile
Lyophylized Powder for
Intravenous use only
9-04-14
11-04-14
MANUFACTURER
LOCAL AGENT
STATUS
Glenmark Generics SA,
Buenos Aires, Argentina
T. Geddes Grant
Distributors Limited
List 4
pemetrexed disodium
equivalent to pemetrexed 500mg
Glenmark Generics SA,
Buenos Aires, Argentina
T. Geddes Grant
Distributors Limited
List 4
Imovax Polio Suspension
for Injection in
Multidose- Poliomyelitis
Vaccine (inactivated)
Sanofi Pasteur S.A., Lyon,
France
Cari-Med Limited
List 4
Duodart 0.5mg/0.4mg Hard
Capsules
2Dutaseride 0.5mg &
Tamsulosin Hydrochloride
0.4mg
Catalent Germany
Schorndorf GmbH,
Steinbeisstr, Schorndorf,
Germany
GlaxoSmithKline
Caribbean Limited
List 4
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
15-04-14
Lizolid IV Injection
600mg/300ml
Linezolid IV Injection
600mg/300ml
Glenmark Pharmaceuticals
Ltd., Kheda, Gujarat, India
T. Geddes Grant
Distributors Ltd
List 4
11-04-14
Stribild Tablets
Patheon Inc., Canada
H.D. Hopwood & Company
Ltd.
List 4
11-04-14
Uro-Vaxom Capsules
Each tablet contains 150mg
elvitegravir, 150mg cobicistat,
200mg emtricitabine, 300mg
tenofovir disoproxil fumarate
equivalent to 245mg tenofovir
disoproxil
Standardized lyophilizate 60mg
corresponding to 6mg of
lyophilized bacterial lysates of
Escherichia Coli
OM Pharma SA, Switzerland
Qualcare Limited
List 4
14-04-14
Octocaine Ointment 5% mint flavored
Novocol Inc, USA
Glen Logan
List 4
Lidocaine base 5%
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
14-04-14
Oni Cream (Betamethasone BP
0.05%
Clotrimazole BP 1% each gram of
cream contains betameth {as
dipropionate} 0.5mg and
clotrimazole BP 10mg asone BP
Square Pharmaceuticals Ltd.,
Bangladesh
R.A. Williams
Distributors Ltd
List 4
23-04-14
Glivec 100mg Film-coated Tablets
Imatinib 100mg as Mesilate beta
crystals
Novartis Pharma Produktions
GmbH, Wehr, BadenWürttenberg, Germany
Cari-Med Limited
List 4
22-04-14
Stelera 90mg Solution for
Injection in
Pre-filled syringe for
subcutaneous use Ustekinumab
90mg/ml
Baxter Pharmaceuticals
Solutions LLC, Bloomington,
USA & Cilag AG,
Schaffhausen, Switzerland
Cari-Med Limited
List 4
17-04-14
Amisped 4mg Chewable Tablets
Montelukast sodium 4.2mg
equivalent to montelukast base
4mg
Sanofi Aventis de Colombia
S.A.
Cari-Med Limited
List 4
17-04-14
Amisped 5mg Chewable Tablets
Montelukast sodium 5.2mg
equivalent to montelukast base
5mg
Sanofi Aventis de Colombia
S.A.
Cari-Med Limited
List 4
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
17-04-14
Amisped 10mg Film-coated
Tablets
Montelukast sodium 10.375mg
equivalent to montelukast base
10mg
Sanofi Aventis de Colombia S.A.
Cari-Med Limited
List 4
23-04-14
Ticas 0.05% Cream
Each 100gm cream contains
fluticasone propionate BP
0.05gm
Square Pharmaceuticals Ltd.,
Bangladesh
R.A. Williams
Distributors Ltd
List 4
23-04-14
Ticas 0.005% Ointment
Each 100gm ointment contains
fluticasone propionate BP
0.005gm
Square Pharmaceuticals Ltd.,
Bangladesh
R.A. Williams
Distributors Ltd
List 4
24-04-14
Zimax 500 Tablets
Each tablet contains
azithromycin dihydrate USP
524.04mg equivalent to
azithromycin 500mg
Square Pharmaceuticals Ltd.,
Bangladesh
R.A. Williams
Distributors Ltd
List 4
24-04-14
Metaspray Metered Dose Nasal
Spray 50mcg/spray
Each spray contains
mometasone furoate BP
50mcg
R.A. Williams
Distributors Ltd
List 4
29-04-14
Nufer Syrup
Unimed Health Care Ltd
List 4
Square Pharmaceuticals Ltd.,
Bangladesh
Indus Pharmaceuticals,
Kancheepuram, India
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
29-04-14
Foseal – 800 Tablets
Sevelamer hydrochloride
800mg
Emcure Pharmaceuticals Ltd.,
Maharashtra State, India
Servi-Care Distributors Limited
List 4
29-04-14
Orofer Capsules
Emcure Pharmaceuticals Ltd.,
Jammu, India
Servi-Care Distributors Limited
List 4
29-04-14
Orofer Syrup
Emcure Pharmaceuticals Ltd.,
Jammu, India
Servi-Care Distributors Limited
List 4
30-04-14
Pegasys Solution for Injection in
Pre-filled Pen; 180
micrograms/0.5ml; subcutaneous
use
Pegasys Solution for Injection in
Pre-filled Pen; 135
micrograms/0.5ml; subcutaneous
use
Olpadin Sterile Eye Drops
Iron {III} hydroxide
polymaltose complex equivalent
to elemental iron, 100mg; folic
acid B.P., 550mcg
Each 5ml contains: Iron {III}
hydroxide polymaltose complex
equivalent to elemental iron,
50mg
Each pre-filled pen contains:
135 micrograms peginterferon
alfa-2a {40 KD}
Catalent Belgium, Brussels,
Belgium
Facey Commodity Company Ltd
List 4
Each pre-filled pen contains:
135 micrograms peginterferon
alfa-2a {40 KD})
Catalent Belgium, Brussels,
Belgium
Facey Commodity Company Ltd
List 4
Each 1 ml contains olopatadine
hydrochloride, INN, equivalent
to olopatadine 1mg
Aristopharma Ltd., Dhaka,
Bangladesh
R.A. Williams Distributors
Ltd
List 4
30-04-14
30-04-14
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
30-04-14
Low Molecular Weight Heparin
Enoxaparin
Sodium Injection 20mg/0.2
Enoxaparin sodium Ph. Eur
20mg/0.2mlml PFs
Gland Pharma Limited,
Hyderabad, India
Medical Products Limited
List 4
List 4
List 4
List 4
List 4
List 4
List 4
DRUGS REGISTERED IN MAY 2014
DATE
2-05-14
PRODUCT
Chlocol Eye Drops
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
Chloramphenicol, B.P., 0.5% w/v
M/S Flagship Biotech
International, Dist., Thane, India
Uni-Med Health Care Ltd
List 4
2-05-14
Pefotrex-500 for Injection;
lyophilized; vials; for I.V.
Infusion only
Each vial contains pemetrexed
500mg as premetrexed disodium
M/S Flagship Biotech
International, Dist., Solan, India
Uni-Med Health Care Ltd.,
List 4
2-05-14
Panpure IV for Injection;
lyophilized; vials; for I.V.
Injection only
Emcure Pharmaceuticals Ltd.,
Gujarat State, India
Servi-Care Distributors Limited
List 4
5-05-14
Antiplar Tablets
Each combipack contains: 1 vial,
containing S,pantoprazole sodium
equivalent to S (-) pantoprazole
20mg plus 10mg sterile sodium
chloride Injection IP
Clopidogrel bisulfate, U.S.P.,
equivalent to clopidogrel 75mg
Emcure Pharmaceuticals Ltd.,
Gujarat State, India
Servi-Care Distributors Limited
List 4
Telmisartan
KrKa d.d., Novo Mesto, Slovenia
Servi-Care Distributors Limited
List 4
8-05-14
Tolura 40mg Tablets
8-05-14
Tolura 80mg Tablets
Telmisartan
KrKa d.d., Novo Mesto, Slovenia
Servi-Care Distributors Limited
List 4
9-05-14
Nolicin 400mg film coated
Tablets
Norfloxacin 400mg
KrKa d.d., Novo Mesto, Slovenia
Servi-Care Distributors Limited
List 4
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
13-05-14
Vasilip 10mg film coated Tablets
Simvastatin
KrKa d.d., Novo Mesto,
Slovenia
Servi-Care
Distributors Limited
List 4
13-05-14
Vasilip 20mg film coated Tablets
Simvastatin
KrKa d.d., Novo Mesto,
Slovenia
Servi-Care
Distributors Limited
List 4
13-05-14
Vasilip 40mg film coated Tablets
Simvastatin
KrKa d.d., Novo Mesto,
Slovenia
Servi-Care Distributors
Limited
List 4
List 4
List 4
List 4
List 4
DRUGS REGISTERED IN JUNE 2014
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
10-06-14
Meropenem Sandoz 1000mg
powder for solution for
injection/infusion
Meropenem trihydrate 1.14155g
corresponding to Meropenem per
vial
Sandoz Private Limited, India
Qualcare Limited
List 4
124-06-14
Levolin Inhaler with dose counter
(CFC Free)
Cipla Limited, Verna, Goa,
India
Lasco Distributors
Limited
List 4
24-06-14
Oncogem 1000 Powder for
reconstitution for IV Infusion
Levosalbutamol tartrate
equivalent to levosalbutamol
50mcg per dose suspended in
tetrafluroethane {HFA-134-a}
propellant
Gemcitabine hydrochloride USP
equivalent to Gemcitabine
1000mg
Cipla Limited, Verna, Goa,
India
LOCAL AGENT
Lasco Distributors
Limited
STATUS
List 4
List 4
List 4
List 4
List 4
DRUGS REGISTERED IN JULY 2014
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
24-07-14
Tolucombi 80/12.5mg Tablets
Telmisartan 80mg,
hydrochlorothiazide 12.5mg
KrkA d.d., Novo Mesto, Slovenia
Servi-Care Distributors Limited List 4
25-07-14
Candesartan
Cilexetil/Hydrochlorothiazide
Sandoz 32mg/12.5mg tablets
Health 2000 Fluconazole150mg
Capsules
Each tablet contains candesartan
cilexetil 32mg hydrochlorothiazide
12.5mg
Fluconazole, U.S.P., 150mg
Lek Pharmaceuticals d.d., Slovenia
Qualcare Limited
List 4
S Kant Healthcare Ltd., Gujarat,
India
Health Brands Limited
List 4
16-07-14
Grafeel Filgrastim Injection
300mcg/1 ml vial SC/IV Infusion
Human Recombinant Granulocyte
Colony Stimulating Factor
300mcg/1ml {r-DNA origin})
Dr. Reddy’s Labs Ltd.,
List 4
16-07-14
Grafeel Filgrastim Injection
300mcg/1 ml Prefilled Syringe
SC/IV Infusion
Human Recombinant Granulocyte
Colony Stimulating Factor 300mcg/
per prefilled syringe ml (r-DNA
origin}
Dr. Reddy’s Labs Ltd.,
Biotechnology Division, Ranga
Reddy District, Andhra Pradesh,
India
Dr. Reddy’s Labs Ltd.,
Biotechnology Division, Ranga
Reddy District, Andhra Pradesh,
India
Dr. Reddy’s Labs Ltd.,
List 4
28-07-14
List 4
List 4
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
2-07-14
Fluorouracil Injection BP
250mg/5ml for IV use
Fluorouracil BP 50mg/ml
Naprod Life Sciences PVT Ltd.,
Andheri (East), Mumbai, India
Inter-Commercial Distributors
Limited
List 4
2-07-14
Paclitaxel Injection USP
30mg/5ml for IV Infusion
Paclitaxel USP 6mg/ml
Naprod Life Sciences PVT Ltd.,
Andheri (East), Mumbai, India
Inter-Commercial Distributors
Limited
List 4
2-07-14
Paclitaxel Injection USP
300mg/50ml for IV Infusion
Paclitaxel USP 6mg/ml
Naprod Life Sciences PVT Ltd.,
Andheri (East), Mumbai, India
Inter-Commercial Distributors
Limited
List 4
15-07-14
Cymbalta 30mg gastro-resistant
capsule, hard
Duloxetine hydrochloride
Lilly del Caribe Inc, Puerto Rico
Health Brands Limited
List 4
15-07-14
Cymbalta 60mg gastro-resistant
capsule, hard
Duloxetine hydrochloride
Lilly del Caribe Inc, Puerto Rico
Health Brands Limited
List 4
List 4
List 4
DRUGS REGISTERED IN AUGUST 2014
DATE
12-08-14
14-08-14
14-08-14
PRODUCT
Clean & Clear Continuous
Control Acne Cleanser
Simvor Tablets 10mg
Simvor Tablets 20mg
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
Benzoyl Peroxide 10%)
Kik Custom Products – Rexdale
Plant, Etobicoke, Canada
Simvastatin USP 10mg
Ranbaxy Laboratories Ltd., Dewas, Massy Distribution Ja. Ltd
India
List 4
Simvastatin USP 20mg
Ranbaxy Laboratories Ltd., Dewas, Massy Distribution Ja. Ltd
India
List 4
Cari-Med Limited
List 4
14-08-14
Simvor Tablets 40mg
Simvastatin USP 40mg
Ranbaxy Laboratories Ltd., Dewas, Massy Distribution Ja. Ltd
India
List 4
14-08-14
Enhancin 625mg Tablets
Amoxicillin trihydrate Ph Eur
equivalent to amoxicillin 500mg,
potassium clavulonate Ph Eur
equivalent to clavulanic acid 125mg
Amoxicillin trihydrate Ph Eur
equivalent to amoxicillin 875mg,
potassium clavulonate Ph Eur
equivalent to 125mg
S {-} metoprolol succinate 23.75mg
equivalent to S {-} metoprolol
tartrate 25mg
Ranbaxy Laboratories Ltd., Dewas, Massy Distribution Ja. Ltd
(M.P.), India
List 4
Ranbaxy Laboratories Ltd., Dewas, Massy Distribution Ja. Ltd
(M.P.), India
List 4
14-08-14
Enhancin 1G Tablets
26-08-14
Metpure XL 25 Tablets
Emcure Pharmaceuticals Ltd.,
India
Servi-Care Distributors Limited List 4
DATE
PRODUCT
26-08-14
Metpure XL 50 Tablets
15-08-14
Tramadol-Denk 50mg
Effervescent Tablets
15-08-14
Momate AZ Nasal Spray
15-08-14
Hartmann’s Solution for
Injection BP RL
15-08-14
APO-Latanoprost Ophthalmic
Solution 50mcg/ml
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
S {-} metoprolol succinate 47.5mg
equivalent to S {-} metoprolol
tartrate 50mg
Tramadol Hydrochloride 50mg Ph.
Eur.
Emcure Pharmaceuticals Ltd.,
India
Servi-Care Distributors Limited List 4
Losan Pharma GmbH, Neuenburg,
Germany
Massy Distribution Ja. Ltd
List 4
Mometasone furoate BP 50mcg,
azelastine Hydrochloride BP
140mcg (per spray)
Compound sodium lactate injection
BP (sodium lactate USP
0.32g/100ml, sodium chloride
BP0.6g/100ml, potassium chloride
BP 0.04g/100ml calcium chloride
dihydrate BP 0.027g/100ml
Latanoprost ophthalmic solution
50mcg/ml
Glenmark Pharmaceuticals Ltd.,
Tehsil Nalagarh, Solon, Himachal
Pradesh, India
Ahlcon Parenterals (India) Ltd.,
Bhiwadi, Alwar (Rajasthan), India
T. Geddes Grant Distribution
Ltd
List 4
Medical Products Ltd.
List 4
Apotex Inc., Richmond Hill,
Ontario, Canada
Cari-Med Limited
List 4
List 4
List 4
DRUGS REGISTERED IN SEPTEMBER 2014
DATE
PRODUCT
9-09-14
Dermasol 0.05% Cream
10-09-14
GENERIC DESIGNATION
LOCAL AGENT
STATUS
Square Pharmaceuticals Ltd.,
Bangladesh
R.A. Williams Distributors
Limited
List 4
Apo-Mometasone Aqueous Nasal mometasone furoate 50mcg per dose
Spray – 50mcg per metered
spray
Fluarix Vaccine
Influenza Vaccine (Northern
Hemisphere 2014-2015 IM/SC
Suspension for Injection} See
overleaf
Diprobet Cream 0.05%
Each 100gm cream contains
betamethasone dipropionate BP
0.065GM {equivalent to
betamethasone 0.05gm}
Dermasol 0.05% Ointment
Each 100gm ointment contains
clobetasol propionate BP 0.05mg
Apotex Inc., Canada
Cari-Med Limited
List 4
GlaxoSmithKline Biologicals,
(Branch of SmithKline Beecham
Pharma GmbH & Co. KG)
Germany
Square Pharmaceuticals Ltd.,
Bangladesh
GlaxoSmithKline Caribbean
Ltd
List 4
R.A. Williams Distributors
Limited
List 4
Square Pharmaceuticals Ltd.,
Bangladesh
R.A. Williams Distributors
Limited
List 4
12-09-14
Ezex 0.05% Ointment
Each gm ointment contains
clobetasone butyrate BP 0.5mg
Square Pharmaceuticals Ltd.,
Bangladesh
R.A. Williams Distributors
Limited
List 4
15-09-14
Ezex 0.05% Cream
Each gm contains clobetasone
butyrate BP 0.5mg
Square Pharmaceuticals Ltd.,
Bangladesh
R.A. Williams Distributors
Limited
List 4
18-09-14
11-09-14
12-09-14
Each gram cream contains
clobetasol propionate BP 0.5mg
MANUFACTURER
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
15-09-14
Genvir-500 Tablets
Valacyclovir hydrochloride
equivalent to Valacyclovir 500mg
Genpharma (International) Pvt.
Ltd., Pune, India
Medical Products Limited
List 4
15-09-14
Visag Sterile Ophthalmic
Solution
Azithromycin dihydrate 10mg/1ml
Laboratories Poen S.A.C.I.F.I.,
Buenos Aires, Argentina
T. Geddes Grant Distributors
Ltd
List 4
15-09-14
Amloval 5/80 Tablets
Amlodipine besilate 5mg; valsartan
80mg
Popular Pharmaceuticals Ltd.,
Tongi, Bangladesh
Indies Pharma Ja. Ltd
List 4
15-09-14
Bactrocin 2% Ointment
Each 100gm ointment contains
mupirocin USP 2gm
Square Pharmaceuticals Ltd.,
Bangladesh
R.A. Williams Distributors
Limited
List 4
16-09-14
Encifer Injection (Iron Sucrose
Injection USP
Emcure Pharmaceuticals Ltd.,
Thane, India
Servi-Care Distributors Limited List 4
23-09-14
Xalaprost Eye Drops
Each 5ml contains: ferric hydroxide
in complex with sucrose equivalent
to elemental iron 100mg
Latanoprost 0.05mg/ INN
Beximco Pharmaceuticals Ltd.,
Tongi, Bangladesh
Qualcare Limited
List 4
23-09-14
Biosulin Glargine Injection 100
I.U./ ml; 3ml Vials For S.C. use
only
Popular Pharmaceuticals Ltd.,
Tougi, Gazipur, Bangladesh
Indies Pharma Ja., Ltd.
List 4
DATE
PRODUCT
16-09-14
Vifex Syrup
16-09-14
Lexapro 20mg film coated
tablets
18-09-14
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
Emcure Pharmaceuticals Ltd.,
Thane, India
Servi-Care Distributors Limited List 4
H. Lundbeck A/S, Denmark
Massy Distribution (Jamaica)
List 4
Akridol 6.25mg Tablets
Each 5ml contains: salbutamol
sulphate, B.P., equivalent to
salbutamol, 1mg; bromhexine
hydrochloride, B.P., 2mg;
guaifenesin, B.P., 50mg
Each tablet contains escitalopram
oxalate {INN} 25.54mg
corresponding to escitalopram
20mg)
Carvedilol BP 6.25mg
Akriti Pharmaceuticals Pvt Ltd.,
India
Recharge Distributors Ltd
List 4
18-09-14
Akridol 12.5mg Tablets
Carvedilol BP 12.5mg
Akriti Pharmaceuticals Pvt Ltd.,
India
Recharge Distributors Ltd
List 4
18-09-14
Exelon Patch 15- Transdermal
Patch
LTS Lohmann Therapie-Systeme
AG, Germany
Cari-Med Ltd.
List 4
23-09-14
Apo-Losartan/ HCTZ
100mg/25mg Tablets
Each 15cm² patch contains 27mg
rivastigmine base, in vivo release
rate 13.3mg/24h
Losartan potassium 100mg,
hydrochlorothiazide 25mg
Apotex Research Pvt Ltd., India
Cari-Med Ltd
List 4
23-09-14
Apo-Losartan/ HCTZ
50mg/12.5mg Tablets
Losartan potassium 50mg,
hydrochlorothiazide 12.5mg
Apotex Research Pvt Ltd., India
Cari-Med Ltd
List 4
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
24-09-14
Moxflag CV 625 Tablets
Bharat Parenterals Limited, India
Uni-Med Health Care Limited
List 4
24-09-14
Moxflag CV 1000 Tablets
Bharat Parenterals Limited, India
Uni-Med Health Care Limited
List 4
25-09-14
Irbesartan Sandoz 300mg Film
Coated Tablets
Irbesartan 300mg
LEK Pharmaceuticals d.d.,
Slovenia
Qualcare Limited
List 4
25-09-14
Irbesartan Sandoz 150mg Film
Coated Tablets
Irbesartan 150mg
LEK Pharmaceuticals d.d.,
Slovenia
Qualcare Limited
List 4
25-09-14
Baxmune 500mg Tablets
Mycophenolate mofetil Ph. Eur
500mg
Ranbaxy Laboratories Limited,
India
Massy Distribution (Jamaica)
List 4
25-09-14
Seroquel XR Extended Release
Tablets 150mg
Quetiapine Fumarate equivalent to
150mg Quetiapine
Astra Zeneca Pharmaceuticals LP,
USA
Cari-Med Limited
List 4
List 4
DRUGS REGISTERED IN OCTOBER 2014
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
6-10-14
Levepsy 500 Tablets
Levetiracetam USP 500mg
Cipla Limited, India
Lasco Distributors Limited
List 4
6-10-14
Levepsy 750 Tablets
Levetiracetam USP 750mg
Cipla Limited, India
Lasco Distributors Limited
List 4
7-10-14
Diclofenac Gel 1%
S Kant Healthcare Ltd., Gujarat,
India
Health Brands Limited
List 4
8-10-14
Fungiloc Vaginal Pessaries
100mg
Diclofenac diethylamine B.P.,
1.16%% w/w equivalent to
diclofenac sodium B.P., 1% w/w
Each pessary contains clotrimazole
BP 100mg
Meridian Enterprises Pvt. Ltd.,
India
Uni-Med Healthcare Limited
List 4
8-10-14
Mometasone Furoate 50mcg
Nasal SpraySuspension
Lek Pharmaceuticals d.d., Slovenia
Qualcare Ltd
List 4
9-10-14
Each actuation delivers 100mg of
suspension containing mometasone
furoate monohydrate equivalent to
50mcg mometasone furoate
Lamivudine, U.S.P., 30mg;
Zidovudine, U.S.P., 60mg
Lamivudine/Zidovudine
Dispersible Tablets
30mg/60mg
Quexel 850mg film coated tablets Metformin hydrochloride 850mg
Mylan Laboratories Ltd.,
Maharashtra State, India
Recharged Distributors Limited List 4
Sanofi Aventis de Colombia S.A
Massy Distribution (Jamaica)
Ltd
17-10-14
List 4
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
23-10-14
Ceroxim Suspension 125mg/5ml
Each 5ml suspension contains
cefuroxime axetil
Ranbaxy Laboratories Ltd., India
Massy Distribution (Jamaica)
List 4
Ltd
USP equivalent to cefuroxime 125mg
27-10-14
CoLosar-Denk 100/12.5mg film
coated tablets
Denk Pharma GmbH & Co. KG.,
Germany
Massy Distribution (Jamaica)
Ltd
List 4
27-10-14
Anastrozole Denk 1 film coated
tablets
Losartan potassium 100mg,
hydrochlorothiazide 12.5mg per
tablet
Each film coated tablet contains
anastrozole 1mg
Haupt Pharma Munster GmbH,
Germany
Massy Distribution (Jamaica)
Ltd
List 4
27-10-14
Tri-Luma Cream
Fluocinolone acetonide 0.01%,
hydroquinone 4%, tretinon 0.05%)
G. Production Inc., Canada
Cari-Med Limited
List 4
29-10-14
Synvisc One Intra-articular
Injection 8mg/ml
Metsafe 500 ER Tablets
Genzyme Biosurgery, USA (A
Massy Distribution (Jamaica)
Division of Genzyme Biosurgery
Ltd
Corporation
MSN Laboratories Private Limited, Lasco Distributors Ltd
India
List 4
30-10-14
30-10-14
Metsafe 1000 ER Tablets
Contains Hylan GF 20 (repeating
disaccharide units of N acetyl
glucosamine and sodium
Each uncoated table contains
metformin hydrochloride USP
500mg as extended release form
Each uncoated table contains
metformin hydrochloride USP
1000mg as extended release form
MSN Laboratories Private Limited, Lasco Distributors Ltd
India
List 4
List 4
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
31-10-14
Lamictal Chewable Dispersible
Tablets 2mg
Lamotrigine
GlaxoSmithKline LLC, NC, USA
GlaxoSmithKline Caribbean
Ltd
List 4
31-10-14
Levolet 750 Tablets
Dr. Reddy’s Laboratories Ltd.,
India
Medical Disposables Limited
List 4
31-10-14
Erian Ointment
Levofloxacin hemihydrate 768.7mg
equivalent to levofloxacin 750mg per
film coated tablet
Cinchocaine hydrochloride BP 5mg,
hydrocortisone BP 5mg, framycetin
sulphate BP 10mg, esculin 10mg per
gram of ointment
Square Pharmaceuticals Ltd.,
Bangladesh
R.A. Williams Distributors Ltd
List 4
List 4
List 4
List 4
List 4
DRUGS REGISTERED IN NOVEMBER 2014
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
11-11-14
Vaxigrip 0.25ml Prefilled Syringe
Influenza Vaccine 2014-2015
Sanofi Pasteur S.A., Lyon, France
Cari-Med Limited
List 4
11-11-14
Vaxigrip 0.5ml Prefilled Syringe
Influenza Vaccine 2014-2015
Sanofi Pasteur S.A., Lyon, France
Cari-Med Limited
List 4
3-11-14
One (1) ml pre-filled pen contains 100mg
golimumab
Baxter Pharmaceuticals Solutions
LLC, USA
Cari-Med Limited
List 4
3-11-14
Simponi Solution for Injection
100mg/1ml in Prefilled pen
(Smartject-single use for SC
Injection)
Erian Suppositories
R.A. Williams
Distributors Ltd
List 4
3-11-14
LDNIL 40 Tablets
Lasco Distributors Ltd
List 4
5-11-14
Cerezol 20 Capsules
Temozolomide USP 20mg
Flagship Biotech International,
India
Uni-Med HealthCare
Limited
List 4
5-11-14
Cerezol 100 Capsules
Temozolomide USP 100mg
Flagship Biotech International,
India
Uni-Med HealthCare
Limited
List 4
100mg/1ml in
Each suppository contains cinchocaine hydro Square Pharmaceuticals Ltd.,
- chloride BP 5mg, hydrocortisone BP 5mg
Bangladesh
framycetin sulphate BP 10mg, esculin 10mg
Rosuvastatin calcium 41.6mg equivalent to
MSN Laboratories Private
Rosuvastatin 40mg
Limited, India
DATE
PRODUCT
4-11-14
Oncogem 200 Powder for
reconstitution for IV Infusion
5-11-14
Esomac IV Lyophilized Injection
40mg
14-11-14
Invokana Film-Coated Tablets
300mg
14-11-14
Invokana Film-Coated Tablets
100mg
17-11-14
Cextaz - Ceftazidime for
Injection USP 1000mg for IV/IM
useVancocyn 1 – Vancomycin
Hydrochloride for Injection
Vancocyn 1 – Vancomycin
Hydrochloride for Injection USP
1G for IV use only
Vancocyn – Vancomycin
Hydrochloride for Injection USP
500mg for IV use only
17-11-14
17-11-14
GENERIC DESIGNATION
Gemcitabine Hydrochloride USP
equivalent to Gemcitabine 200mg &
Sodium Chloride Injection IP 0.9%
w/v
Esomeprazole sodium for Injection
equivalent to Esomeprazole 40mg &
Sodium Chloride Injection IP 0.9%
w/v
Canagliflozin 300mg as canagliflozin
hemihydrate306mg
MANUFACTURER
LOCAL AGENT
STATUS
Cipla Limited, Verna, Goa, India
Lasco Distributors Limited
List 4
Cipla Limited, Verna, Goa, India
Lasco Distributors Limited
List 4
Janssen – Ortho LLC, Gurabo,
Puerto Rico, USA / Janssen – Cilag
SpA, Italy (packaged & released)
Canagliflozin 100mg as canagliflozin Janssen – Ortho LLC, Gurabo,
hemihydrate102mg
Puerto Rico, USA / Janssen – Cilag
SpA, Italy (packaged & released)
Ceftazidime USP 1000mg as
Vida Laboratories Pvt. Ltd.,
ceftazidime pentahydrate a blend of Wilson Garden, Bangalore, India
sterile ceftazidime perntahydrate &
sterile sodium carbonate
Vancomycin Hydrochloride USP
Vida Laboratories Pvt. Ltd.,
equivalent toVancomycin 1G
Wilson Garden, Bangalore, India
Cari-Med Limited
List 4
Cari-Med Limited
List 4
Medical Disposables & Supplies
Limited
List 4
Medical Disposables & Supplies
Limited
List 4
Vancomycin Hydrochloride USP
equivalent to Vancomycin 500mg
Medical Disposables & Supplies
Limited
List 4
Vida Laboratories Pvt. Ltd.,
Wilson Garden, Bangalore, India
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
17-11-14
Rovas 5 film coated tablets
Rosuvastatin calcium 5.21mg
equivalent to Rosuvastatin 5mg
Intas Pharmaceuticals Ltd.,
India
Wray & Nephew Ltd.,
(formerly Lascelles Ltd.)
List 4
17-11-14
Rovas 20 film coated tablets
Rosuvastatin calcium 20.84mg
equivalent to Rosuvastatin 20mg
Intas Pharmaceuticals Ltd.,
India
Wray & Nephew Ltd.,
(formerly Lascelles Ltd.)
List 4
17-11-14
Gyno V6 Vaginal Tablets 100mg
Clotrimazole USP 100mg
Akriti Pharmaceuticals Pvt.
Ltd., India
Recharged Distributors Ltd
List 4
18-11-14
Cefotan 1 – Cefotaxime for Injection
IV/IM use
Medical Disposables &
Supplies Limited
List 4
18-11-14
Tenox 5mg Tablets
Cefotaxime sodium USP equivalent
Vida Laboratories Pvt. Ltd.,
to cefotaxime 1G
USP 1G
Wilson
for Garden, Bangalore,
India
Amlodipine besilate 6.94mg
Krka d.d., Novo Mesto, Slovenia
equivalent to 5mg amlodipine
Servi-Care Distributors Ltd
List 4
18-11-14
Tenox 10mg Tablets
Amlodipine besilate 13.88mg
equivalent to 10mg amlodipine
Krka d.d., Novo Mesto, Slovenia Servi-Care Distributors Ltd
List 4
19-11-14
Benzetacil L-A 1200000 IU Powder for
Suspension for Injection; IM use
Each 5ml vial contains benzathine
penicillin G 1200000 IU
Fresenius Kabi Anti-Infectives
S.r.l., Villadose (RO), Italy
List 4
Qualcare Limited
DATE
19-11-14
PRODUCT
21-11-14
Benzetacil L-A 2400000 IU
Powder for Suspension for
Injection; IM use
Glidara 500 Tablets
21-11-14
Glidara 850 Tablets
21-11-14
Protride 5 film coated tablets
21-11-14
Grani-Denk 1mg/ml; 1ml
concentrate for solution for
injection or infusion – single use
ampoules for IV use
Prasusafe 5 tablets
24-11-14
24-11-14
Losar-Denk 25 film coated
tablets
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
Each 5ml vial contains benzathine
penicillin G 2400000 IU
Fresenius Kabi Anti-Infectives
S.r.l., Villadose (RO), Italy
Qualcare Limited
List 4
Each film coated tablet contains
metformin hydrochloride USP
500mg
Each film coated tablet contains
metformin hydrochloride USP
850mg
Finasteride 5mg USP
Medicamen Biotech Ltd., India
Medical Products Limited
List 4
Medicamen Biotech Ltd., India
Medical Products Limited
List 4
Unicure Remedies Pvt. Ltd., India
Health Brands Ltd
List 4
Each ml concentrate contains
granisetron hydrochloride 1.12mg
corresponding to granisetron 1mg
Hameln Pharmaceutical GmbH,
Germany
Massy Distribution (Jamaica)
Ltd.,
List 4
Each film coated tablet contains
prasugrel hydrochloride 5.49 mg
equivalent to prasugrel 5mg
Each film coated tablet contains
losartan potassium 25mg equivalent
to losartan 22.9mg
MSN Laboratories Limited, India
Lasco Distributors Ltd
List 4
hydro
Massy Distribution (Jamaica)
Ltd.
List 4
Denk Pharma GmbH & Co. KG,
Gollstr. 1, 84529 Tittmoning,
Germany
DATE
25-11-14
PRODUCT
26-11-14
Herceptin 150mg powder for
concentrate for IV infusion –
single dose vial
Inalix SR 1.5mg tablets
26-11-14
Aerius Oral Solution 0.5mg/ml
26-11-14
Zoledro-Denk 4mg/5ml
concentrate for solution for
infusion – vial for IV single use
27-11-14
Equinixin 25mg/g Granules for
Horses
27-11-14
Norodine 24 Solution for
Injection for IV/IM/SC use
27-11-14
Advil Max Soft Gel Capsules
400mg
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
One vial contains 150mg
trastuzumab; reconstituted solution
contains 21mg/ml trastuzumab
Each film coated sustained release
tablet contains indapamide USP
1.5mg
Desloratadine
Roche Diagnostics GmbH,
Mannheim, Germany
Facey Commodity Company
Ltd
List 4
S Kant HealthCare Ltd., India
Health Brands Ltd
List 4
Schering Plough S.A. de CV,
Mexico
Health Brands Ltd
List 4
One vial with 5ml concentrate
contains zoledronic acid
monohydrate 4.264mg
corresponding to zoledronic acid
4mg
Flunixin 250mg as flunixin
meglumine BP Veterinary Use Only
Hameln Pharmaceutical GmbH,
Germany
Massy Distribution (Jamaica)
Ltd
List 4
Trimethoprim 40mg/ml
suphadiazine 200mg/ml in in 100ml
bottle Veterinary Use Only
Ibuprofen 400mg
Norbrook Laboratories Ltd.,
Hi-Pro Farm Supplies
Newry, Co, Down, Northern
Ireland
Norbrook Laboratories Ltd.,
Hi-Pro Farm Supplies
Newry, Co Down, Northern Ireland
List 4
Procaps S.A., Colombia
List 4
Facey Commodity Company
Ltd
List 4
DATE
PRODUCT
GENERIC DESIGNATION
14-11-14
Ran CV 500-Ranolazine
Extended Release Tablets 500mg
Ranolazine 500mg
19-11-14
Silotrif 8 – Silodosin Capsules
8mg
Silodosin 8mg (IHS)
19-11-14
Silotrif 4 – Silodosin Capsules
4mg
Silodosin 4mg
27-11-14
Devomycin D Solution for
Injection for IM use only
28-11-14
Candizar – 4 Tablets
Streptomycin Sulphate 150mg/ml;
dihydrostreptomycin Sulphate
150mg/ml in 100ml bottle
Veterinary Use Only
Candesartan cilexetil 4mg
28-11-14
Candizar – 8 Tablets
28-11-14
Candizar – 16 Tablets
MANUFACTURER
LOCAL AGENT
STATUS
MSN Laboratories Pvt. Ltd.,
Medak Dist., Andhra Pradesh,
India
MSN Laboratories Pvt. Ltd.,
Medak Dist., Andhra Pradesh,
India
MSN Laboratories Pvt. Ltd.,
Medak Dist., Andhra Pradesh,
India
Norbrook Laboratories Ltd.,
Newry, Co Down, North Ireland
Lasco Distributors Ltd
List 4
Lasco Distributors Ltd
List 4
Lasco Distributors Ltd
List 4
Hi-Pro Farm Supplies
List 4
Ind-Swift Ltd., Global Business
Unit, Punjab, India
Indies Pharma Ja. Ltd
List 4
Candesartan cilexetil 8mg
Ind-Swift Ltd., Global Business
Unit, Punjab, India
Indies Pharma Ja. Ltd
List 4
Candesartan cilexetil 16mg
Ind-Swift Ltd., Global Business
Unit, Punjab, India
Indies Pharma Ja. Ltd
List 4
DRUGS REGISTERED IN DECEMBER 2014
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
8-12-14
Cefimax – Cefepime for Injection USP
1G for
IM/IV use
Cefepime hydrochloride USP
equivalent for cefepime 1G
Vida Laboratories Pvt. Ltd.,
Wilson Garden, Bangalore, India
Medical Disposables &
Supplies Limited
List 4
8-12-14
esomeprazole sodium equivalent
to 40mg per vial
Vida Laboratories Pvt. Ltd.,
Wilson Garden, Bangalore, India
Medical Disposables &
Supplies Limited
List 4
10-12-14
Espraz – Esomeprazole Sodium for
Injection 40mg Powder for
reconstitution for IV use only
Neupro Transdermal Patch 2mg/24h
Rotigotine 4.5mg per 10cm2 patch
LTS Lohmann Therapie-Systeme
AG, Andernach, Germany
Cari-Med Limited
List 4
10-12-14
Neupro Transdermal Patch 4mg/24h
Rotigotine 9mg per 20cm2 patch
LTS Lohmann Therapie-Systeme
AG, Andernach, Germany
Cari-Med Limited
List 4
10-12-14
Neupro Transdermal Patch 6mg/24h
Rotigotine 13.5mg per 30cm2
patch
LTS Lohmann Therapie-Systeme
AG, Andernach, Germany
Cari-Med Limited
List 4
10-12-14
Neupro Transdermal Patch 8mg/24h
Rotigotine 18mg per 40cm2 patch
LTS Lohmann Therapie-Systeme
AG, Andernach, Germany
Cari-Med Limited
List 4
18-12-14
Enbrel Myclic 50mg Solution for
Injection in Per-filled pen –
subcutaneous use
Etanercept
Pfizer Ireland Pharmaceuticals,
Ireland
Facey Commodity Co. Ltd
List 4
DATE
PRODUCT
GENERIC DESIGNATION
MANUFACTURER
LOCAL AGENT
STATUS
16-12-14
Aristomol 0.5% Eye Drops
Timolol maleate, B.P., 0.5%
Aristopharma Ltd., Dhaka,
Bangladesh
R. A. Williams Distributors
Limited
List 4
16-12-14
Salinocarb Powder
Ilender Peru S.A., Lima, Peru
Jamaica Broilers Group Ltd
List 4
16-12-14
Esmya 5mg Tablets
Sodium salimomycin 10%;
nicarbazine 10%) Veterinary Use
Only - Poultry
Ulipristal acetate 5mg
Gedeon Richter PLC., Budapest,
Hungary
Medimpex Jamaica Ltd
List 4
27-12-14
Combivit Solution for Injection
for SC/IM Use
Norbrook Laboratories Ltd.,
Newry, Co Down, North Ireland
Hi-Pro Farm Supplies
List 4
18-12-14
Bridion 200mg/2ml Solution for
Injection – vial for IV single
bolus; single use
Bridion 500mg/5ml Solution for
Injection – vial for IV single
bolus; single use
Epnone 25 Film Coated Tablets
Thiamine HCL 3.5% w/v, riboflavin
sodium phosphate 0.05% w/v,
pyridoxine HCL 0.7% w/v,
nicotinamide 2.3% w/v, ascorbic
acid 7% w/v in 100ml bottle
Veterinary Use Only
Sugammadex sodium
NV Organon, Netherlands
Health Brands Ltd
List 4
Sugammadex sodium
NV Organon, Netherlands
Health Brands Ltd
List 4
Eplerenone 25mg tablet
MSN Laboartories Ltd., Bollaram,
Medak Dist., Andhra Pradesh,
India
Lasco Distributors Limited
List 4
18-12-14
18-12-14
DATE
PRODUCT
GENERIC DESIGNATION
17-12-14
Nature’s Soul Bioprist’s Herbal
Iron Capsules Blood Enriching
Formula
18-12-14
Epnone 50 Film Coated Tablets
Micronised iron 200mg,, emblica
officinalis (Indian gooseberry)
75mg, terminalia bellerica (beleric)
5mg,terminalia chebula (yellow
myrobalan)75mg, glycyrrhiza
glabra (liquorice) 75mg per
capsule/per serving}
Eplerenone 50mg tablet
18-12-14
Tolvat 15 Tablets
Tolvaptan 15mg tablet
18-12-14
Tolvat 30 Tablets
Tolvaptan 30mg tablet
18-12-14
Kadcyla 100mg Powder for
Concentrate for Solution for
infusion – vial for IV use
Kadcyla 160mg Powder for
Concentrate for Solution for
infusion – vial for IV use
Prezista Oral Suspension
100mg/ml
18-12-14
22-12-14
MANUFACTURER
LOCAL AGENT
STATUS
Bacfo Pharmaceuticals (India)
Ltd., Noida, India
Indies Pharma Ja. Ltd
List 4
Lasco Distributors Limited
List 4
Lasco Distributors Limited
List 4
Lasco Distributors Limited
List 4
Trastuzumab emtansine
MSN Laboartories Ltd., Bollaram,
Medak Dist., Andhra Pradesh,
India
MSN Laboartories Ltd., Bollaram,
Medak Dist., Andhra Pradesh,
India
MSN Laboartories Ltd., Bollaram,
Medak Dist., Andhra Pradesh,
India
DSM Pharmaceuticals Inc., USA
Facey Commodity Co. Ltd
List 4
Trastuzumab emtansine
DSM Pharmaceuticals Inc., USA
Facey Commodity Co. Ltd
List 4
Darunavir 100mg/ml (as darunavir
ethanolate 108.4mg/ml
Janssen-Cilag International,
Beerse, Belgium
Cari-Med Limited
List 4