Expedite Registration Application – DRA Bhutan

Bovirum Bolus

Application to Expedite Registration 

of

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

1. Letter of Authorization from the manufacturer

– The letter of authorization to KARMA Group, Bhutan from Cadila Healthcare Ltd.,
Ahmedabad, India, is attached with the application.

2. Price Structure

Price structure is attached herewith

Confidential
 Expedite Registration Application – DRA Bhutan
Bovirum Bolus

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.

Confidential
 Expedite Registration Application – DRA Bhutan
Bovirum Bolus

7. Product Profile

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

Rumenotoric bolus containing Antimony Potassium Tartrate, Ferrous
Sulphate, Copper Sulphate and Cobalt Chloride

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

BOVIRUM

c. Dosage form:
Bolus

d. Strength of the finished product:

Antimony Potassium Tartrate USP 2.0 gm

Dried Ferrous Sulphate IP 2.0 gm
Copper Sulphate Anhydrous BP 50 mg
Cobalt Chloride 100 mg

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

pharmacopoeias or manufacturer’s in-house specification):

Product is developed and validated 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 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

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.

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.

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.

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.

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

(clear), suspension, emulsion, etc

NA – Bolus form

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

quantity/weight/volume, etc.:

-A Blister Strip of 4's and a box of 25 strips

Confidential