FORM DA-1/88

APLICATION FORM FOR THE REGISTRATION OF DRUGS (WHICH ARE INCLUDED AS

MONOGRAPH IN GP/BPC/USP-MF/INT.PH. OR ALREADY 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 : Aspartame

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

________________________________________________________________________

4. PRODUCT DATA SHEET

a) Presentation and Packaging Quantities:

Box contains 10 blister of 10’s tablets. Each tablet contains Aspartame 1gm.

b) Description:
Aspartame is broken down in the body to the amino acids aspartic acid and phenylalanine as
well as a small amount of methanol. It is a mixture of 40 percent aspartic acid, 50 percent of
phenylalanine, and 10 percent of methanol
Methanol is quickly absorbed through the stomach and small intestine mucosa. The methanol
is converted into formaldehyde (a known carcinogen). Then, via aldehyde hydrogenase, the
formaldehyde is converted to formic acid. These two metabolites of methanol are toxic and
cumulative.

c) Indications and Uses:

Aspartame offers people with type 1 and type 2 diabetes greater variety and flexibility in
budgeting their total carbohydrate intake and helps them satisfy their taste for sweets without
affecting blood sugar.

d) Dosage and Administration:

Aspartame adds sweetness to your hot drinks anytime, anywhere so that you can still enjoy a
delicious, sweet taste without the calories. Each tablet dissolves easily in your tea and coffee
and gives the same sweetness of one teaspoon of sugar.

e) Contraindications:
The only people who should not use Aspartame are those with phenylketonuria (PKU), a rare,
genetic metabolic disorder diagnosed at birth, which leaves affected unable to tolerate
standard levels of an essential amino acid called phenylalanine

f) Pregnancy and lactation:

Aspartame is not effective in heat nor for long periods in liquid form. It is often found as an
additive to soft drinks, gelatin, desserts, pudding mixes, breakfast cereals, beverages,
chewing gum, dairy products, and other foods and drugs. According to the Food and Drug
Administration(FDA), Aspartame is safe for use during pregnancy and lactation.

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 It is recommended to limit consumption to a moderate level.

g) Precautions:
There is a substantial amount of evidence supporting the safety of aspartame in the general
public.  Since the components that it is broken down to (methanol, aspartic acid and
phenylalanine) are found in greater quantities in common everyday foods, it is unlikely that a
person will become toxic or experience adverse effects from aspartame.  There is also little
chance that the dangerous, even life threatening, effects that some people attribute to
aspartame are indeed true.  It is possible, however, that a very small subset of our population
is sensitive to the artificial sweetener and may exhibit benign symptoms such as a headache,
nausea, and dermatological reactions.

h) Side-effects:
Sugar-free products are popular, but the leading artificial sweetener, aspartame, is
controversial. Activists claim there’s a link between aspartame and a multitude of ailments,
including:
1. cancer
2. seizures
3. depression
4. lupus
5. multiple sclerosis 

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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:

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