FORM DA -1/88
APPLICATION FORM FOR REGISTRATION OF DRUGS
(WHICH ARE INCLUDED IN MONOGRAPH IN BP/BPC/USP-NF/INT. PH. AND
ALREADY INTRODUCED IN BANGLADESH)
1. Name & Address of the Manufacturer : Veritas Pharmaceuticals Ltd.
Muradpur, Vannara, Mouchak,
Kaliakoir, Gazipur
2. Manufacturing License No. : a) Biological : 288
b) Non-biological : 492
3. Name of the Drug : a) Generic name -
Ascorbic Acid BP 250 mg per Tablet
: b) Brand name –
To be submitted at the time of inclusion
4. Product Data Sheet : Please see Annexure -I (enclosed)
5. Technical Data Sheet : Please see Annexure -II (enclosed)
6. a) Number of Manufacturers already : About 60 manufacturers
manufacturing the product in Bangladesh
b) Estimated market of this product/ : 25 million (approx.) Tablet are consumed per year
product group in Bangladesh
7. a) Proposed maximum retail price : To be submitted at the time of inclusion.
b) i) Estimated price per dose : To be submitted at the time of inclusion.
ii) Estimated price per day treatment : Depends on Physician’s advice.
iii) Cost for the recommended course of : Depends on Physician’s advice.
treatment
8. For Locally Manufacturing Drugs : Please see Annexure III (enclosed)
Particulars of Production Manager and
Quality Assurance Manager
9. Information regarding imported Drugs : Not applicable.
10. Date of submission :
11. Additional information (if any) : None
Annexure I
4. PRODUCT DATA SHEET
Composition
Each tablet contains Ascorbic Acid BP 250 mg per Tablet.
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Mode of Action:
In humans, an exogenous source of ascorbic acid is required for collagen formation and tissue repair.
Ascorbic acid is reversibly oxidized to dehydroascorbic acid in the body. These two forms of the
vitamin are believed to be important in oxidation-reduction reactions. The vitamin is involved in
tyrosine metabolism, conversion of folic acid to folinic acid, carbohydrate metabolism, synthesis of
lipids and proteins, iron metabolism, resistance to infections, and cellular respiration.
Indications and Uses:
Vitamin C is recommended for the prevention and treatment of scurvy. Its parenteral administration
is desirable for patients with an acute deficiency or for those whose absorption of orally ingested
ascorbic acid is uncertain.
Symptoms of mild deficiency may include faulty bone and tooth development, gingivitis, bleeding
gums, and loosened teeth. Febrile states, chronic illness, and infection (pneumonia, whooping cough,
tuberculosis, diphtheria, sinusitis, rheumatic fever, etc.) increase the need for ascorbic acid.
Hemovascular disorders, burns, delayed fracture and wound healing are indications for an increase in
the daily intake.
Dosage and Administrations:
Ascorbic acid is usually administered orally. When oral administration is not feasible or when
malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given
parenterally, utilization of the vitamin reportedly is best after IM administration and that is the
preferred parenteral route.
For intravenous injection, dilution into a large volume parenteral such as Normal Saline, Water for
Injection, or Glucose is recommended to minimize the adverse reactions associated with intravenous
injection.
The average protective dose of vitamin C for adults is 70 to 150 mg daily. In the presence of scurvy,
doses of 300 mg to 1 g daily are recommended. However, as much as 6 g has been administered
parenterally to normal adults without evidence of toxicity.
To enhance wound healing, doses of 300 to 500 mg daily for a week or ten days both preoperatively
and postoperatively are generally considered adequate, although considerably larger amounts have
been recommended. In the treatment of burns, doses are governed by the extent of tissue injury. For
severe burns, daily doses of 1 to 2 g are recommended. In other conditions in which the need for
vitamin C is increased, three to five times the daily optimum allowances appear to be adequate.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
administration, whenever the solution and container permit.
Contraindications:
Contraindicated in those persons who have shown hypersensitivity to any component of this
preparation.
Use in Pregnancy and lactation:
Ascorbic acid has been assigned to pregnancy category A by the FDA when used in doses that are
advocated by the FDA. Doses exceeding the recommended dietary allowance (RDA) have been
assigned to pregnancy category C. Animal studies have not been reported. There are no controlled
data in human pregnancy. Ascorbic acid is only recommended for use during pregnancy when
benefit outweighs risk.
High doses of ascorbic acid taken during pregnancy have been reported to cause conditional scurvy
in infants following birth.
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During pregnancy and lactation indicated dosage of Vitamin-C is safe.
Precautions and warning:
General Precautions: Too-rapid intravenous injection is to be avoided.
Laboratory Tests: Diabetics taking more than 500 mg vitamin C daily may obtain false readings of
their urinary glucose test. No exogenous vitamin C should be ingested for 48 to 72 hours before
amine-dependent stool occult blood tests are conducted because possible false-negative results may
occur.
Diabetics, patients prone to recurrent renal calculi, those undergoing stool occult blood tests, and
those on sodium-restricted diets or anticoagulant therapy should not take excessive doses of vitamin
C over an extended period of time.
Side effects:
Generally Ascorbic acid is well tolerated. However, few side-effects including stomach upset,
diarrhea, mouth sores, or frequent urination may be seen after administration of Ascorbic acid.
Over dosage:
If overdose is suspected, patients should contact to local poison control center or emergency room
immediately. Symptoms of overdose may include change in amount of urine or joint pain.
Storage:
Store in a cool and dry place, protected from light.
Package Quantities:
Each box contains 10 Alu-Alu blister strip of 10 chewable tablets.
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Annexure II
5. TECHNICAL DATA
a) Composition : Each tablet contains
Active Substance Specifications Quantity Overage
Ascorbic Acid BP 250 mg 3%
Sodium Ascorbate BP 60 mg 3%
Excipients
Lactose BP 68.000 mg
Mannitol BP 50.000 mg
Aspartame BP 0.250 mg
Povidone K 30 BP 2.500 mg
Orange Lake Color Ph Grade 0.030 mg
Orange Flavor Powder Ph Grade 1.000 mg
Magnesium Stearate BP 1.250 mg
b) Manufacturing Process
Step-1: Weigh accurately Ascorbic Acid, Sodium Ascorbate, Mannitol, Aspartame, Orange
Lake color,Orange Flavor Powder and Aerosil 200. Sieve through 30 mesh and mix
for 10 minutes.
Step-2: Weigh Magnesium Stearate, add to the dried granules and mix for 1 minute.
Step-3: After QA approval compress into tablets using appropriate tool.
Step-4: Compressed tablet after QA approval are ready for coating.
Packing:
Step-5: Coated tablets after QA approval are packed in blister strips, each containing 10 tablets.
Step-6: Blister strips are further packed in printed cartons in 10 X 10’s quantities.
c) Control data for Active Substances : As indicated under specification in 5 a).
d) Control data for Excipients : As indicated under specification in 5 a).
e) Control data for finished product
Appearance : A orange colored, round shaped, one side engraved
with “V” and other side break line tablet.
Average weight(mg) : Approx. 435 mg
Disintegration time : Not more than 30 minutes
Dissolution : Not less than 75% within 45 minutes
Assay : 90% to 110% of the label claim.
Claim : 250.0 mg 225.00 mg – 275.00 mg
f) Stability data : Will be submitted at the time of inclusion.
g) Proposed shelf life : Two years from the date of manufacturing.
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Annexure III
8. PARTICULARS OF PRODUCTION MANAGER AND QA MANAGER
Plant Manager:
1. Full Name Md. Didarul Alam
2. Qualification M. Pharm
3. Date of joining to Veritas Pharma Ltd. 06th October 2020
4. Total Experience 18 Years
5. Registration Number A-2406
6. Signature
7. Date
QA In-Charge:
1. Full Name Md. Tawhidunnabi
2. Qualification M. Pharm
3. Date of joining to Veritas Pharma Ltd. 11th July 2019
4. Total Experience 06 Years
5. Registration Number A-12767
6. Signature
7. Date
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