Recipe of Enrofloxacin ORS

RECIPE FOR
NAME OF THE PRODUCT:

ENROFLOXACIN BP 10 % VET ORAL SOLUTION
SUBMITTED BY
GENTRY PHARMACEUTICALS LTD.
House #39, Road # 27, Sector # 07, Uttara, Dhaka-1230
Page 1 of 6
FORM-DA- 1/88
APPLICATION FORM FOR THE REGISTRATION OF DRUGS (WHICH ARE INCLUDED
AS MONOGRAPH IN BP/BPC/USP-NF/NT.PH.OR ALREADY INTRODUCED IN
BANGLADESH).
01. Name and address of the Manufacturer

GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur
02. Manufacturing License Number

a) Biological : 26
b) Non-Biological : 27
03 Name of the Drugs

a) Generic Name: Enrofloxacin BP
b) Name under which the drug is proposed to be sold: To be submitted at the time of
inclusion.
04. Product Data Sheet

a) Presentation: Each ml Oral Solution contains Enrofloxacin BP 100 mg
b) Description:
Enrofloxacin inhibits the activity of DNA-gyrase enzyme, leasing to reduction in super coiling
and serious disruption of the spatial arrangement of DNA. As a result bacterial life cycle is
disrupted. The action of Enrofloxacin (quinolone) is bacteriocidal and the viability of
susceptible organisms is usually lost within 20-30 min of exposure to optimal antibacterial
concentration.
c) Indications:
Gastrointestinal infections, respiratory infections and urinary tract infections caused by
Enrofloxacin sensitive micro-organisms, like Campylobacter, E. coli, Haemophilus,
Mycoplasma, Pasteurella and Salmonella spp. in calves, goats, poultry, sheep and swine.
d) Dosage and Administration :

For oral administration:

Calves, goats and sheep:
Twice daily 10 ml per 75 - 150 kg body weight for 3 - 5 days.

Poultry:
1 ml per 1.5 - 2 litres of drinking water for 3 - 5 days.
Swine:
1 ml per 1 - 3 litres of drinking water for 3 - 5 days.
Note: for pre-ruminant calves, lambs and kids only.

Or, as per direction of registered Veterinarian.
Page 2 of 6
e) Contraindications:
Hypersensitivity to Enrofloxacin.
Administration to animals with a seriously impaired hepatic and/or renal function.
Administration to poultry producing eggs for human consumption.
Administration to pregnant or lactating animals.
Concurrent administration of tetracyclines, chloramphenicol, macrolides and lincosamides.
f) Side effects:
Administration to young animals during growth can cause cartilage lesions in joints.
Hypersensitivity reactions.
g) Withdrawal times:
For Egg : 7 days
For Meat : 12 days
h) Storage:
Store in a cool and dry place protected from light. Keep out of reach of children.
i) Package quantities:
100 ml, 500 ml & 1000 ml solution in Plastic bottle.
05. Technical Data:

A) Composition /Formula:
Each 100 ml Oral Solution contains:
Composition Specification Quantity Overage Usage
a) Active substance
1. Enrofloxacin BP 10.000 gm 2.0% API
b) Excipients
1. Sodium BP 1.500 gm Solubilizing
Hydroxide agent
2. Propylene Glycol BP 10.000 ml Stabilizing
agent
3. Sodium Sulfite BP 0.100 gm Antioxidant
4. Phenylmercuric BP 0.002 gm Preservative

Acetate
5. Purified water BP q.s. to 100.000 ml Diluent
Page 3 of 6
B) Manufacturing Instructions:
Precautions:
1. The operator and personnel must wear protecting clothing, caps. hand gloves, face
mask, eye protector and working shoes during manufacturing to protect him/herself
against raw materials that might be come in contact with the skin and inhaling into
lungs.
2. All manufacturing area must be thoroughly cleaned before going to production.
3. All manufacturing equipments and utensils must be thoroughly cleaned and dried
before using as per Standard Operating Procedure (SOP).
4. The personnel working at the manufacturing area must have a good state of health and
should show qualities of neatness and oderliness.
5. All manufacturing operations will be conducted in compliance with good
manufacturing practice (GMP).
Processing steps:
Step-1:
Clean and sanitize all the equipments and area as per SOP.
Step-2:
Check all the containers of raw materials having QC approval tag and shelf-life.
Step-3:
Weigh all the raw materials as per Batch Manufacturing Record (BMR).
Step-4:
Take required amount of purified water in a cleaned S.S. charge vat and add Sodium
Hydroxide into the charge vat with continuous stirring.
Step-5:
Slowly add Enrofloxacin into charge vat and continue stirring to dissolve Enrofloxacin and
add Propylene Glycol into charge vat.
Step-6:
Dissolve Sodium Sulfite in water and add to Step-5 and dissolve Phenylmercuric Acetate in
required amount of Propylene Glycol and add into charge vat.
Step-7:
Add purified water in the charge vat to adjust the required volume and continue the stirring for
30 minutes and then filter the solution.
Step-8 :
Request the Quality Control to draw sample for in-process control and after QC approval fill
and seal the bottle as per specifications.
Step- 9:
Request the Quality Control to draw sample (filled & sealed bottle) for in-process control
and take QC approval for packing.
Page 4 of 6
C) Control data for the active ingredient:

BP/BPC/USP-NF/INT.PH. Will be followed.
D) Stability data:
Stability data will be submitted at the time of inclusion.
E) Proposed shelf life:

To be submitted at the time of inclusion.
06. a) Number of manufacturer already manufacturing this product in

Bangladesh:
15 (Approx.). Enrox 10 (Techno), Enrocin (Renata), Enrovet (ACME), Enroflox-Vet
(Square), G-Enrox (Vet) (ACI) etc.
b) Estimated market of this product in Bangladesh:

Approximately 30 crores.
07. a) Proposed Maximum Retail Price ( MRP ):

As fixed by the Government of Bangladesh.
b) Estimated price per dose per day treatment & cost for the recommended
courses of treatment:
All depends on the prescription recommended by the Registered Veterinarian.
Page 5 of 6
08. For Locally Manufactured Drugs (Particulars of Manager, Quality Assurance,
Manager, Production and Sr. Executive, Product Development).
01. Manager, Quality Assurance
a) Name :
b) Qualification :
c) Date of joining :
d) Total experience :
e) Registration No. :
f) Signature :
02. Manager, Production

a) Name :
b) Qualification :
f) Signature :
03. Sr. Executive, Product Development

a) Name :
b) Qualification :
f) Signature :
09. Information regarding imported Drugs: Not applicable.
10. Date of Submission:
Page 6 of 6

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RECIPE FOR

NAME OF THE PRODUCT:

01. Name and address of the Manufacturer

02. Manufacturing License Number

03 Name of the Drugs

04. Product Data Sheet

d) Dosage and Administration :

Note: for pre-ruminant calves, lambs and kids only.

05. Technical Data:

4. Phenylmercuric BP 0.002 gm Preservative

C) Control data for the active ingredient:

E) Proposed shelf life:

06. a) Number of manufacturer already manufacturing this product in

b) Estimated market of this product in Bangladesh:

07. a) Proposed Maximum Retail Price ( MRP ):

02. Manager, Production

03. Sr. Executive, Product Development

09. Information regarding imported Drugs: Not applicable.

10. Date of Submission:

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