PRIMARY PRODUCT REGISTRATION

PRODUCT NAME

Butamirate Citrate

SUBMITTED BY
EVEREST Pharmaceuticals Ltd.
Kanchpur BSCIC, Sonargaon, Narayanganj
BANGLADESH

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 FORM DA – 1/88

APPLICATION FORM FOR THE REGISTRATION OF DRUGS

(WHICH ARE INCLUDED AS MONOGRAPH IN USP/USPC/USP-NF/INT.PH.OR ALREADY
INTRODUCED IN BANGLADESH)

01. Name and address of the Manufacturer

EVEREST Pharmaceuticals Ltd.
Kanchpur BSCIC, Sonargaon, Narayanganj

02. Manufacturing Licence Number

a) Biological :178
b) Non-Biological :336

03 Name of the Drugs

a) Generic Name : Butamirate Citrate
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 5 ml contains 7.5mg Butamirate Citrate.

b) Uses:
Butamirate Citrate is used to relieve dry (non-productive) cough. Dry cough may be caused by a
recent viral infection. It is also used for pre- & post-operative cough sedation in patients who will
undergo surgical procedures and bronchoscopy. It can be used in acute cough of any etiology,
whooping cough and cough due to acute lower respiratory tract infections (tracheitis, laryngitis,
bronchitis) etc.

c) Dosage and Administration:

Tablet:
Adult: 2-3 tablets daily at 8 to 12 hours intervals,

Adolescents over 12 years old: 1-2 tablets daily.

Syrup:
Children (3-6 years): 5 ml 3 times daily,

Children (6-12 years): 10 ml 3 times daily,

Adolescent: 15 ml 3 times daily,

Adult: 15 ml 4 times daily.

Pediatric Drops:
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Children (1-3 years): 0.75 ml 4 times daily,
Children (2 months-1 year): 0.50 ml 4 times daily

d) Contraindications:
Butamirate Citrate is contraindicated in patients with known hypersensitivity to any component of the
formulation.
e) Precautions:
Avoid simultanous administration of expectorants. Minor influence on the ability to drive & use
machines. Avoid during pregnancy (1st 3 months) & lactation.

Tablet: Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-
galactose malabsorption.

Syrup: Sorbitol: Rare hereditary problems of fructose intolerance. Contains ethanol.

f) Drug Interactions:
Avoid use with expectorants.

g) Adverse reactions:
Tolerance of Butamirate Citrate is good. Adverse reactions such as rash, nausea and vertigo have been
observed in a few rare cases, resolving after dose reduction or treatment withdrawal
h) Package quantities:

To be submitted at the time of inclusion.

05.
Technical Data
a) Composition/Formula
Ingredients Specifications Quantity/ Function of
Tablet Excipients
Active Ingredient

Excipients

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 Coating Materials

* Solvent does not appear in the final product.

b) Manufacturing Instructions:

6. a) Number of manufacturer already manufacturing this product in Bangladesh:

N/A

b) Estimated market of this product in Bangladesh:

N/A

c) Control data for the active ingredient:

Butamirate Citrate

d) Stability data:
Stability data is to be submitted at the time of inclusion.
e) Proposed shelf life:
Stability data is to be submitted at the time of inclusion.

7. 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 physician.

08. a) Particulars of Head of Production

Full Name : Shah Galib Eftekhar

Qualification : M. Pharm.
Date of Joining in the applicant Company : 02.11.2019
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 Total experience in the Pharmaceutical Industries: 9 Years
Registration No. : A-5728

Signature : _________________

b) Particulars of Head of Quality Assurance

Full Name : Md. Ruknuzzaman Rony

Qualification : M. Pharm.
Date of Joining in the applicant Company : 05.05.2019
Total experience in the Pharmaceutical Industries: 14 Years
Registration No. : A-2754

Signature : _________________

09 : Date of Submission :

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