API source validation service in Bangladesh

Required documents for API source validation in Bangladesh

1. Letter of Authorization (Attested by Bangladesh embassy/Chamber of Commerce)

2. Principal company profile (Attested by Bangladesh embassy/Chamber of Commerce)

3. Principal company manufacturing license (Attested by Bangladesh embassy/Chamber of Commerce)

4. Registered office address of the Manufacturer & the factory address (Attested by Bangladesh embassy/Chamber of Commerce)

5. GMP Certificate (Attested by Bangladesh embassy/Chamber of Commerce)

6. List of Countries where the API is being exported (Attested by Bangladesh embassy/Chamber of Commerce)

7. Certificate of Analysis (COA) with Specification of the API/RM (Attested by Bangladesh embassy/Chamber of Commerce)

8. Product list of the manufacturer (Attested by Bangladesh embassy/Chamber of Commerce)

9. Form-9 (mentioning the product name) – Signed by the manufacturer

Validity of Source validation certificate: 3 years

*All documents must be submitted as Original copy.

Please, ship the documents to:

Md. Kamruzzaman

Address: 1/3 Nandipara, Road 12, Khilgaon, 1219, Dhaka, Bangladesh

Phone (1): 01978041545

Phone (2): 01813364189

We provide Biosimilar API registration service in Bangladesh