To,
The Deputy Drugs Controller,
Health and OTC products,
Drug Regulatory Authority of Pakistan,
Islamabad.
Subject:
Product Enlistment of BRONZE ENHANCEMENT TILLA
Respected Sir,
We M/s TASEER HERBAL PHARMA, A-780A, Mohan Pura, Rawalpindi-Pakistan are herewith,
submitting the product dossier of our locally manufactured natural product “BRONZE ENHANCEMENT
TILLA” on the prescribed form. All the necessary documents with original Challan fee receipt are attached
here with this application for your perusal. Your kind concern is requested in this regard.
Thanking in anticipation,
Truly yours,
Hakeem & Dr.
TARIQ MEHMOOD TASEER
Chairman
FORM-4
[(See rule 3(3)]
APPLICATION FOR ENLISMENT OF LOCALLY MANUFACTURED INDIGENOUS UNANI
MEDICINE, HER BAL MEDICINAL PRODUCTS (PHYTOMEDICINE) HOMOPATHIC,
MEDICINE OR HEALTH PRODUCTS FOR THERAPEUTIC OR DISEASE REDUCTION
CLAIMS
(Attached readable soft copy with application)
I, Hakeem & Dr. TARIQ MEHMOOD TASEER owner of M/s TASEER HERBAL PHARMA hereby
apply for enlistment of following product manufactured by my firm/company (has already applied as
manufactured) located at the premises as under: TASEER HERBAL PHARMA, A-780A, Mohan Pura,
Rawalpindi-Pakistan
1. Product Profile
S. Brand Name of Product: BRONZE ENHANCEMENT TILLA
N
Common Name of
Recommended
o
List of Ingredients with Strength
Ingredients
Uses
1.
2.
3.
4.
5.
White Rooster’s spleen
water
Mimusops elengi L
6 mg
Rosa
Pandanus
Lawsonia inermis
Ambergris
Moschus moschiferus
Crocus sativus
Opium poppy
Mimusops elengi L
1 mg
1 mg
1 mg
3 mg
6 mg
6 mg
1 mg
1 mg
Coccinia grandis
Lumbricina
Aquilaria malaccensis
Wax
1 mg
3 mg
6 mg
6 mg
Q.S
White Rooster’s
spleen water
Mimusops Elengi
Flower
Rose
screwpine
Henna
Ambergris
Pure Musk
Saffron
Poppy seeds extrat
Mimusops Elengi
Extract
Arania Coccinia
Earthworms
Eagle Wood
Wax
Erectile
Dysfunction,
Premature
Ejaculation,
Bended, Weak
and Small
Organ.
Pack
Size
50gm
Maximum
Retail
Price
Rs.2200/-
Master Formula. (Annexure A)
Manufacturing process and in process controls (Annexure B)
Testing specification for Raw Material and finished products. (Annexure C)
Shelf life and storage. (Shell life shall base on stability data). In case data not available then letter of
commitment for submission of data be submitted. (Annexure D)
6. Recommended Conditions for use. Evidence for therapeutic or disease reduction claims as per standards
of evidence (Annexure E)
7. Packaging and labeling. (Annexure F)
8. Maximum Retail price. (Annexure G)
9. Fee deposit receipt. (Fee deposited Challan copy attached)
10.I undertake and certify that the contents stated above are correct true to the
best of my knowledge (Attached undertaking on the notarized stamp paper).
Name of the owner
Hakeem & Dr. TARIQ MEHMOOD TASEER
Signature ………………….
Seal of the firm/ company
Dated…………………..
(Annexure A)
Master Formula
Active ingredients:
Each 1 g contains:
White Rooster’s spleen
water
Mimusops elengi L
6 mg
Rosa
Pandanus
Lawsonia inermis
Ambergris
Moschus moschiferus
Crocus sativus
Opium poppy
Mimusops elengi L
1 mg
1 mg
1 mg
3 mg
6 mg
6 mg
1 mg
1 mg
Coccinia grandis
Lumbricina
Aquilaria malaccensis
Wax
1 mg
3 mg
6 mg
6 mg
Excipients:
nil
Q.S
(Annexure B)
Manufacturing process
Manufacturing process is consisted of following:
a)
b)
c)
d)
e)
f)
g)
h)
Purify all the ingredients completely and wash with distilled water.
Boil on low temperature and get the joshanda.
Filter the joshanda with the help of Cloth.
Then put oil into the stainless steel pot.
Point out the upper layer stainless steel pot.
Now put joshanda into pot and boil it.
Boils that specific point. Then away from the fire.
Tilla is ready for use.
In Process Controls ( BY Q.C. Department)
1.
2.
3.
4.
Boiling of water upto 30 mins
Maintenance of filling volume at the time of filling
Monitoring of volume variation.
Proper preparation of the extracts
(Annexure C)
Testing specification of Raw Material
(Manufacturer specification)
Testing specification
(Manufacturer’s Specification)
Average volume in a bottle:
50 grams
Volume Variation:
+/- 0.5 gm
pH of the OIL :
------
Color of the OIL:
(As per the control)
Taste of the OIL:
no flavor
(Annexure D)
Shelf life and storage
Shelf Life:
For 2 years
Storage:
Keep the product in cool and dry place at room temperature, Keep out of the children’s reach.
Letter of Commitment for Stability Data
This is to commit that we are working on the stability data of the said product. The moment the product
completes its shell life we shall submit the stability data as monitored by our Quality Control department, for
your perusal
Name of the owner
Hakeem & Dr. TARIQ MEHMOOD TASEER
Signature ………………….
Seal of the firm/ company
Dated…………………..
(Annexure E)
Recommended Conditions for use
Indications:
Erectile Dysfunction, Premature Ejaculation, Bended, Weak and Small Organ.
Dosage:
Rub tilla gently on the sexual organ (except the glands and bottom of the organ) at night before going to
sleep.
References:
(Annexure F)
Packaging and labeling
Label:
Pack:
(Annexure G)
Maximum Retail price.
Maximum Retail Price. Rs: 2200/-
Undertaking
I undertake and certify that the contents stated above regarding the “BRONZE ENHANCEMENT
TILLA” are correct true to the best of my knowledge. That the product is manufactured as per the good
manufacturing practices.
Name of the owner
Hakeem & Dr. TARIQ MEHMOOD TASEER
Signature ………………….
Seal of the firm/ company
Dated…………………..