Astaxanthin-4mg Soft Gelatin Capsule

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

________________________________________________________________________
4. PRODUCT DATA SHEET
a) Presentation and Packaging Quantities:

Box contains 2 blister stripes of 10’s soft gelatin capsules. Each soft gelatin capsule contains
Astaxanthin 4mg.
b) Description:
Astaxanthin acts as an antioxidant by dual mode of action. It suppresses singlet oxygen and
also inhibits lipid peroxidation. By these actions it reduces the harmful free radicals.
Therefore acts as a very strong antioxidant. Astaxanthin is absorbed by passive diffusion into
the intestinal epithelium alongside fatty acids. Then it is incorporated into lipoproteins,
transported to the liver, via lymph and blood and partly resecreted with lipoproteins. More
than 70% of the Astaxanthin is contained in high-density lipoprotein part of plasma. Highest
concentration of Astaxanthin is in the small intestine, followed by subcutaneous fat, spleen,
liver, heart, kidney and skin and lowest in the muscles.
c) Indications and Uses:

 Strong antioxidant
 Improves cardiovascular health (Atherosclerosis, reduce cholesterol).
 Improves immune function.
 Improves condition of skin
 Protects skin from damage caused by sun (Reduce wrinkles, pimples and other signs
of aging)
 Improves recovery from central nervous system injuries
 Protects from Parkinson ’s disease, Dementia and Alzheimer's
 Protects eyes from cataracts and macular degeneration.
 Reduces inflammation (Arthritis)
 Reduces risk of infertility
Also Astaxnthin effectively reduce oxidative damage to DNA, decrease the risk for many
types of cancer and stabilize blood sugar.
d) Dosage and Administration:
Adults (18 years and older) - Daily dose is 4mg. should be taken along with or immediately
prior to meals in the morning.
4 m.g. – Used as a strong antioxidant, improves cardiovascular health (Atherosclerosis,
reduce cholesterol), improves immune function.
4-8 m.g. - Improves condition of skin, protects skin from sun damage (Reduce wrinkles,
pimples and other signs of aging), improves recovery from central nervous system injuries
and protects eyes from cataracts and macular degeneration.
8-12 m.g.- Reduces inflammation (Arthritis)
16 m.g. - Reduces risk of infertility
e) Contraindications:
Contraindicated for those with known allergies to Astaxanthin.
f) Pregnancy and lactation:

Both pregnant women and lactating mothers should avoid Astaxanthin supplements as no
data on safety has been found yet.
g) Side-effects:
No severe side effects have been reported yet.
h) Drug Interaction:
Concomitant intake of Astaxanthin with Cholestyramine, Colestipol, Mineral oil, Orlistat may
reduce the absorption rate of Astaxanthin.
i) Overdose:
No case of overdose has occurred with Astaxanthin
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
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

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FORM DA-1/88

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

1. NAME OF THE MANUFACTURER : Incepta Pharmaceuticals Ltd.

2. MANUFACTURING LICENCE NOS. : a) Biological 108

3. NAME OF THE PREPARATION :

a) Generic Name : Astaxanthin

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

4. PRODUCT DATA SHEET

a) Presentation and Packaging Quantities:

c) Indications and Uses:

f) Pregnancy and lactation:

I. Name of the Substance Specification Qty./ml

Sodium Starch Glycolate BP 3.000

c) Control Data for the Active material:

d) Pharmacopoeia References for other constituents:

e) Control Data for finished product:

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:

MAHBUBUL KARIM A.K.M. ZAKARIA

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

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

Total experience in Pharmaceutical Total experience in Pharmaceutical

9) In case of imported drugs : Not applicable

10) Date of Submission :

11) Additional Information (if any) : Not applicable

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