Registration Application –BHUTAN

Injectiphos (Butaphosphan and Cyanocobalamin ) Injection

Application to Expedite Registration 

of

Injectiphos (Butaphosphan and Cyanocobalamin)

Injection
(For Veterinary Use)

To
Drug Regulatory Authority (DRA), Bhutan 

Applicant
Zydus Animal Health
(A Division of Cadila Healthcare Limited)
5th Floor, Astron Tech Park, Satellite Cross Roads,
Ahmedabad- 380 015, Gujarat. INDIA.

June 2020

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 Registration Application –BHUTAN
Injectiphos (Butaphosphan and Cyanocobalamin ) Injection

1. Letter of Authorization from the manufacturer

– The letter of authorization to KARMA Pharmaceuticals ane medical supplies, Bhutan for
from Cadila Healthcare Ltd., Ahmedabad, India, is attached with the application.

2. Price Structure

Price structure is attached herewith

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 Registration Application –BHUTAN
Injectiphos (Butaphosphan and Cyanocobalamin ) Injection

3. QC procedure (Method of Analysis ) of finished product

The method of analysis is attached as following pages.

4. Certificate of Analysis of Finished product

COA of Finished product is attached as following pages

5. Product Sample

The product samples are provided along with application.

6. Specimen of Package, Label and insert

Specimens each of Package and Label are provided with the application.

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 Registration Application –BHUTAN
Injectiphos (Butaphosphan and Cyanocobalamin ) Injection

7. Product Profile

a. Generic or International Non-proprietary name (INN):

Butaphosphan and Cyanocobalamin for injection

b. Brand name or trade name (if applicable):

Injectiphos

c. Dosage form:

Solution for injection

d. Strength of the finished product

Butaphosphan....100 mg /ml
Cyanocobalamin IP (Vitamin B12)...0.05mg /ml
N-Butyl Alcohol (as preservative)..3%v/v
Water for Injection IP... q.s.

e. Reference of the official standards of the finished product (e.g. compendial

pharmacopoeias or manufacturer’s in-house specification):

Product is developed as per In-house specification.

f. List of all the ingredients in the dosage form and their amount on a per unit
basis, as per the label claim and batch quantities.

Details of all the ingredients in the dosage form as per label claim is as below

Each ml contains:
Butaphosphan....100 mg /ml
Cyanocobalamin IP (Vitamin B12)...0.05mg /ml
N-Butyl Alcohol (as preservative)..3%v/v
Water for Injection IP... q.s.
Details of all the ingredients in the dosage form as per batch quantities is attached
in following pages.

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 Registration Application –BHUTAN
Injectiphos (Butaphosphan and Cyanocobalamin ) Injection

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 Registration Application –BHUTAN
Injectiphos (Butaphosphan and Cyanocobalamin ) Injection

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 Registration Application –BHUTAN
Injectiphos (Butaphosphan and Cyanocobalamin ) Injection

g. Description of the organoleptic characteristics of the finished product

Characteristic. Please find more details as mentioned in the attached COA of

Finished product.

h. Description of the organoleptic characteristics of the product, including

shape, size, superficial markings for identification purposes, colour, odour,
taste, consistency, type of tablet coating, type of capsule, superficial markings
for identification purposes, etc.

Pink color clear solution.

Please find more details as mentioned in the attached COA of Finished product.

i. Physico-chemical properties such as colour, shape, particle size, pH,

solubility in water and other solvents, existence/absence of polymorphs and
pseudo-polymorphs, hygroscopic nature, etc.

Pink color clear solution.

Please find more details as mentioned in the attached COA & MOA of Finished
product.

j. When describing a liquids, state clearly whether it is in the form of a solution

(clear), suspension, emulsion, etc

Pink color clear solution.

k. Commercial presentation of packaging and pack size in terms of

quantity/weight/volume, etc.:

- 30 ml vial

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