Академический Документы
Профессиональный Документы
Культура Документы
Dicrysticin-S Injection
Dicrysticin-S 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
Confidential
Registration Application –BHUTAN
Dicrysticin-S Injection
2. Price Structure
Confidential
Registration Application –BHUTAN
Dicrysticin-S Injection
5. Product Sample
Specimens each of Package and Label are provided with the application.
Confidential
Registration Application –BHUTAN
Dicrysticin-S Injection
7. Product Profile
Dicrysticin
c. Dosage form:
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
Details of all the ingredients in the dosage form as per batch quantities is attached
in following pages.
Confidential
Registration Application –BHUTAN
Dicrysticin-S Injection
White fine, free flowing powder, practically free from extraneous matter.
Please find more details as mentioned in the attached COA of Finished product.
White fine, free flowing powder, practically free from extraneous matter.
Please find more details as mentioned in the attached COA & MOA of Finished
product.
NA – Powder for injection. After suspension in water for injection, should form
uniform suspension without agglomerates.
Confidential