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Application To Expedite Registration: Regulatory Authority (DRA), Bhutan
Application To Expedite Registration: Regulatory Authority (DRA), Bhutan
Application To Expedite Registration: Regulatory Authority (DRA), Bhutan
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
Confidential
Registration Application –BHUTAN
Neuroxin-M (Methylcobalamin, Vit. B6 & Nicotinamide ) Injection
2. Price Structure
Confidential
Registration Application –BHUTAN
Neuroxin-M (Methylcobalamin, Vit. B6 & Nicotinamide ) Injection
5. Product Sample
Specimens each of Package and Label are provided with the application.
Confidential
Registration Application –BHUTAN
Neuroxin-M (Methylcobalamin, Vit. B6 & Nicotinamide ) Injection
7. Product Profile
Neuroxin-M
c. Dosage form:
Methylcobalamin IP 500mcg/ml
Pyridoxine HCl IP 50 mg/ml
Nicotinamide IP 50 mg/ml
Benzyl alcohol IP 2% v/v
Water for Injection IP qs
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 :
Methylcobalamin IP ...500mcg
Pyridoxine HCl IP ......50 mg
Nicotinamide IP....... 50 mg
Benzyl alcohol IP .......2% v/v
Water for Injection IP .....qs
Details of all the ingredients in the dosage form as per batch quantities is attached
in following pages.
Confidential
Registration Application –BHUTAN
Neuroxin-M (Methylcobalamin, Vit. B6 & Nicotinamide ) Injection
Confidential
Registration Application –BHUTAN
Neuroxin-M (Methylcobalamin, Vit. B6 & Nicotinamide ) Injection
Confidential
Registration Application –BHUTAN
Neuroxin-M (Methylcobalamin, Vit. B6 & Nicotinamide ) Injection
Confidential
Registration Application –BHUTAN
Neuroxin-M (Methylcobalamin, Vit. B6 & Nicotinamide ) Injection
Please find more details as mentioned in the attached COA of Finished product.
- 30 ml vial
Confidential