Professional Documents
Culture Documents
Bovirum Bolus
Bovirum bolus
(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
Expedite Registration Application – DRA Bhutan
Bovirum Bolus
2. Price Structure
Confidential
Expedite Registration Application – DRA Bhutan
Bovirum Bolus
5. Product Sample
Specimens each of Package and Label are provided with the application.
Confidential
Expedite Registration Application – DRA Bhutan
Bovirum Bolus
7. Product Profile
BOVIRUM
c. Dosage form:
Bolus
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 uncoated Bolus contains:
Antimony Potassium Tartrate USP 2.0 gm
Dried Ferrous Sulphate IP 2.0 gm
Copper Sulphate Anhydrous BP 50 mg
Cobalt Chloride 100 mg Excipients q.s.
List of all the ingredients in the dosage form as per batch quantities is attached in
following pages.
Confidential
Expedite Registration Application – DRA Bhutan
Bovirum Bolus
Confidential
Expedite Registration Application – DRA Bhutan
Bovirum Bolus
Confidential
Expedite Registration Application – DRA Bhutan
Bovirum Bolus
Off- white, Caplet shape, uncoated bolus, Break line on one side and BIOTRIM
DS embossed on other side
Please find more details as mentioned in the attached COA of Finished product.
Offwhite to light gray colored, Oblong, biconvex Shape, Uncoated Bolus with
mottled surface, "Zydus AH" Logo on one side and plain on other side,
Please find more details as mentioned in the attached COA & MOA of Finished
product.
NA – Bolus form
Confidential