FORM DA-2/88

APLICATION FORM FOR THE REGISTRATION OF DRUGS (WHICH ARE NOT INCLUDED AS
MONOGRAPH IN BP/BPC/USP-MF/INT.PH. OR NOT INTORDUCED IN BANGLADESH)
________________________________________________________________________

1. NAME OF THE MANUFACTURER : Incepta Pharmaceuticals Ltd.

AND PLACE OF MANUFACTURING : Savar, Dhaka.
________________________________________________________________________

2. MANUFACTURING LICENCE NOS. : a) Biological 108

b) Non-Biological 193
________________________________________________________________________

3. NAME OF THE PREPARATION :

a) Generic Name : Zinc Orotate

b) Trade/Brand Name : To be submitted during inclusion

________________________________________________________________________

4. PRODUCT DATA SHEET

a) Presentation and Packaging Quantities:

Bottle contains 30’s Tablets. Each film coated tablet contains Zinc Orotate 50mg.

b) Description:
Zinc is an essential trace element necessary for normal human functioning. It serves as an
enzyme cofactor and protects cell membranes from lysis caused by complement activation
and toxin release. Zinc is not stored in the body; therefore, dietary intake is required. Meat
and seafood are rich in zinc. The role of zinc in human health and functioning has primarily
focused on dietary supplementation for the promotion of health and disease prevention.

c) Indications and Uses:

Zinc deficiency, Diarrhea, Aninherited disorder called Wilson’sdisease.

d) Dosage and Administration:

Zinc has been studied in clinical trials for a variety of diseases. Typical daily doses include 12
to 150 mg daily as free zinc, or up to 220 mg as zinc sulfate. Reviews of the role of zinc
supplementation suggest a conservative approach that recognizes a differential effect, with
lower doses having positive effect and higher dosages being potentially harmful, as well as
the potential for displacement of other metal ions.
Bioavailability of zinc is variable, with absorption generally better than aqueous solutions.

e) Contraindications:
Large doses of zinc canlower blood sugar in people with diabetes.High doses above the
recommendedamounts might cause fever, coughing,stomach pain, fatigue.

f) Precautions:
Not found

g) Pregnancy & Lactation:

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 Estimations indicate that 82% of pregnant women worldwide are likely to have inadequate
zinc intakes. Poor maternal zinc nutritional status has been associated with a number of
adverse outcomes of pregnancy, including low birth weight, premature delivery, labor and
delivery complications, and congential anomalies. However, the results of maternal zinc
supplementation trials in the U.S. and developing countries have been mixed. Although some
studies have found maternal zinc supplementation increases birth weight and decreases the
likelihood of premature delivery, two placebo-controlled studies in Peruvian and Bangladeshi
women found that zinc supplementation did not affect the incidence of low birth weight or
premature delivery. Supplementation studies designed to examine the effect of zinc
supplementation on labor and delivery complications have also generated mixed results,
though few have been conducted in zinc-deficient populations. A recent systematic review of
17 randomized controlled trials found that zinc supplementation during pregnancy was
associated with a 14% reduction in premature deliveries; the lower incidence of preterm births
was observed mainly in low-income women. This analysis, however, did not find zinc
supplementation to benefit other indicators of maternal or infant health.

h) Side-effects:
Side-effects includeconstipation, dry mouth, nausea, vomiting,tachycardia, dizziness,
confusion,euphoria, hallucinations, impairedmemory, anxiety, restlessness, urinaryretention,
blurred vision, and rash.Angle-closure glaucoma may occur very rarely.

i) Overdosage:
None

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5. TECHNICAL DATA

a) Composition/Formula

I. Name of the Substance Specification Qty./ml

Active Substance (in mg)
Rivaroxaban
INN 10

II. Excipients

Sodium Starch Glycolate BP 3.000

Lactose BP 10.40
Microcrystalline Cellulose BP 122.5
(Avicel PH 101)
Povidone K 30 BP 10.05
Magnesium Stearate BP 2.000
Colloidal Silicone Dioxide USPNF 2.000

b) Manufacturing Instructions:
1. Place Cetostearyl Alcohol, Mineral Oil, Polysorbate 60 and Sorbitan Monostearate in a
jacketed vessel. Heat to 75°C and mix for 15 minutes.
2. Place water, Glycerin and Benzyl Alcohol in a kettle after passing through 60mesh screen.
Heat to boil and cool to 75°C.
3. Mix step 1 and 2 and sieve through 60 mesh screen
4. Add Betamethasone Valerate and Neomycin sulphate to step 3 and homogenize for 20
minutes. Start congealing and then pass through a Colloid mill.
5. Send sample to QC for analysis.
6. After QC approval, fill the tube to seal as per specification.

c) Control Data for the Active material:

As per BP specification

d) Pharmacopoeia References for other constituents:

As that mentioned in the composition/formula

e) Control Data for finished product:

Appearance : Conform
Color : White to off-white
Label claim/gm : Each gm cream contains Betamethasone Valerate BP
1.22mg and Neomycin Sulphate BP 5mg.

f) Stability Data : To be submitted at the time of inclusion

g) Proposed Shelf Life : To be submitted at the time of inclusion

6. a) Number of manufacturers already manufacturing the product in Bangladesh:

None
b) Estimated market size of the product in Bangladesh: Tk. 10 million (approx.)

7. a) Proposed maximum retail price ( MRP) : To be submitted at the time of inclusion

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 b) Estimated price – per dose; per day treatment, cost for the recommended course of
treatment: To be submitted at the time inclusion.

8. Particulars:

Signature: Signature:

MAHBUBUL KARIM A.K.M. ZAKARIA

Director, Technical Operations Deputy Manager, R & D Formulation

Qualification: Qualification:
B. Pharm. (Hons.) B. Pharm (Hons.)
M. Pharm M. Pharm
.

Registration No. A – 811 Registration No. A – 1617

Date of joining in this company: Date of joining in this company:

1st April. 2004 1st May 2001

Total experience in Pharmaceutical Total experience in Pharmaceutical

Industry: Twenty Five Years Industry: Ten Years

9) In case of imported drugs : Not applicable

10) Date of Submission :

11) Additional Information (if any) : Not applicable