FORM DA-2/88

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

MONOGRAPH IN BP/BPC/USP-NF/INT.PH. OR ALREADY INTRODUCED IN BANGLADESH)
____________________________________________________________________________

1. NAME OF THE MANUFACTURER : Incepta Pharmaceuticals Ltd.

AND PLACE OF MANUFACTURING Savar, Dhaka.
____________________________________________________________________________
2. MANUFACTURING LICENCE NO. : a) Biological 108
b) Non-Biological 193
____________________________________________________________________________

3. NAME OF THE PREPARATION :

a) Generic Name : Cod liver oil

b) Trade/Brand Name : To be submitted at the time of

inclusion
____________________________________________________________________________
PRODUCT DATA SHEET

a) Presentation and Packaging Quantities:

Box contains a container of 100’s soft gelatin capsules. Each soft gelatin capsule
contains EPA 26mg ,DHA 24mg, Vitamin A 670IU, Vitamin D3 67IU & Vitamin E 0.3 IU.

b) Description:
The Vitamin A and D content of Cod Liver Oil ensures that normal dietary requirements
are met and that Vitamin A and D deficiency states are corrected.
The essential fatty acids, Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid
(DHA), found in Cod Liver Oil, undergo beta oxidation, EPA is a precursor of the ‘3’ series
of prostaglandins and in a cascade reaction can lead to the production of thrombozane
A3 and prostacyclin PG13.
Precise data on the rate of turnover of EPA and DHA in lipids of nervous tissue have not
been determined.

c) Indications and Uses:

 Treatment of combined vitamins A, D and E deficiencies.
 Combined vitamins A, D and E and Polyunsaturates supplement to the diet
during childhood and in adults with very poor dietary status.
 Traditional remedy in the symptomatic relief of muscular and joint stiffness and
aches.

d) Dosage and Administration:

For mild to moderate deficiency states: 1-3 capsules three times a day depending on
the age of the patient and the severity of the deficiency. Treatment of the deficiency
should be continued usually between 2 weeks - 2 months until the deficiency state is
corrected.
As a dietary supplement:    Adults and children over 6 years old - 1-2 capsules three
times a day before meals.
Women who are pregnant, lactating or likely to become pregnant - 1 capsule three times
a day.
Do not exceed the stated dose.
To be taken by oral administration.
e) Contraindications:
-    Hypersensitivity to the active substances or to any of the excipients.
-    Hypercalcaemia
-    Hypervitaminoses A, D and E

f) Side-effects:
Vitamin excess can be harmful but a very large overdose of this product would be
needed to produce ill effects.
As most undesirable effects are based on post-marketing spontaneous reporting, precise
frequency estimation is not possible.
-    Gastrointestinal disorders, particularly at high doses, e.g. eructation,
fishy after-taste, nausea, vomiting, abdominal pain, constipation, diarrhoea
-    Moderate increases in hepatic transaminases have been reported in
patients with hypertriglyceridaemia
-    Skin reactions, e.g. acne, eczema and rash Reporting of suspected adverse
reactions

g) Use in pregnancy and lactation:

Seven Seas Cod Liver Oil capsules should only be used after the consultation with a
physician when planning a pregnancy, during pregnancy and lactation. The
recommended dosage must not be exceeded.
Large doses of vitamin A (exceeding 10,000 IU) have been found to be teratogenic if
administered during the first trimester of pregnancy.

h) Precautions:
Do not take other supplements of Vitamin A and D whilst taking this product. Benefits
from Cod Liver Oil supplementation in malabsorption syndromes are unlikely.
Omega-3 fatty acids may have antithrombotic activity at high doses and in patients
susceptible to bleeding. Therefore, they should be given with caution to patients with
haemorrhagic disorders or to those receiving anticoagulants or other drugs affecting
coagulation.
There is some evidence to suggest that fish oil supplements may adversely affect
patients with aspirin-sensitive asthma.
Caution is required in hepatic impairment, particularly if receiving high doses. It is
advisable that patients with hepatic impairment do not receive high doses.

i) Drug Interactions:
Thiazide diuretics with vitamin D may raise calcium levels.
Oestrogen contraceptive pills can raise plasma levels of vitamin A.
In view of a potential effect on bleeding time and platelet aggregation (See Section 4.4),
great care should be exercised in patients on concomitant anti-coagulation therapy or
receiving other drugs which may affect coagulation factors, e.g aspirin, warfarin,
cephalosporin.

j) Over dose:
Vitamin A toxicity generally presents as irritability, vomiting, loss of appetite and skin
changes.
Vitamin D toxicity leads to disturbing of calcium metabolism and calcification of soft
tissues including the lungs and kidneys.
The benefit of gastric decontamination is uncertain. Consider activated charcoal
(charcoal dose: 50 g for adults; 1 g/kg for children) only if the patient presents within  1
hour of ingestion of 1.5 mg/kg (5000 iu/kg) or more vitamin A. Other symptomatic  and
supportive measures should be provided when indicated. Hepatic, renal, cardiac and fluid
electrolyte status should be carefully monitored.
5. TECHNICAL DATA

a) Composition/Formula

I. Name of the Substance Specification Qty./Tablet

Active Substance (in mg)

Aliskiren INN 300

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 the following materials into a Rapid Mixer Granulator (RMG) after passing through
#16 mesh screen (if necessary).
Sodium Starch Glycolate, Lactose, Micro crystalline Cellulose (Avicel PH101).
2) Add Povidone solution to step-1 and mix for 5 to 7 minutes until a granulating mass is
obtained.
3) Discharge the wet mass through to a FBD bowl at slow speed with both Agitator and
Chopper ON.
4) Dry the wet granules in fluid bed dryer at 700 C-750 C temperature. Keep the moisture
content up to 1%.
5) Pass the dried granules through #20 mesh screen and place the granules into double
cone blender.
6) Add Clomiphene Citrate to the step 4 and mix for 20 minutes.
7) Then add Magnesium Stearate and mix it for 1 minute.
8) Send some blend to QC for analysis.
9) Transfer the blend into a suitable tare container line with polybag with proper labeling and
lid.

c) Control Data for the Active material:

As per In House specification

d) Pharmacopoeia References for other constituents:

As that mentioned in the composition/formula

e) Control Data for finished product:

 Appearance : Conform
Color : White
Shape : Round
Hardness : 50N - 80N
Av. tablet wt. : 150 mg
DT : NMT 15 minutes
Label claim/Tablet : Each tablet contains Trifluoperazine Hydrochloride BP 1 mg.

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

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

6. Pharmacological Data:
Pharmacokinetics
The essential fatty acids, Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid
(DHA), found in Cod Liver Oil, undergo beta oxidation, EPA is a precursor of the ‘3’ series
of prostaglandins and in a cascade reaction can lead to the production of thrombozane
A3 and prostacyclin PG13.
Precise data on the rate of turnover of EPA and DHA in lipids of nervous tissue have not
been determined.

7. Clinical Data:
There are no clinincal data of relevance which are additional to those already included in
other sections of the SPC

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

None

b) Estimated market size of the product in Bangladesh: Tk. 10 million (approx.)

9. 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 of inclusion.

10. For locally manufactured drugs:

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

11. In case of imported drugs : Not applicable

12. Date of Submission :

13. Additional Information (if any) : Not applicable