API Source Validation
Documents required:
- Letter of Authorization (Attested by Bangladesh embassy/Chamber of Commerce)
- Principal company profile (Attested by Bangladesh embassy/Chamber of Commerce)
- Principal company manufacturing license (Attested by Bangladesh embassy/Chamber of Commerce)
- Registered office address of the Manufacturer & the factory address (Attested by Bangladesh embassy/Chamber of Commerce)
- GMP Certificate (Attested by Bangladesh embassy/Chamber of Commerce)
- List of Countries where the API is being exported (Attested by Bangladesh embassy/Chamber of Commerce)
- Certificate of Analysis (COA) with Specification of the API/RM (Attested by Bangladesh embassy/Chamber of Commerce)
- Product list of the manufacturer (Attested by Bangladesh embassy/Chamber of Commerce)
- Form-9 (mentioning the product name) – Signed by the manufacturer
- Validity of Source validation certificate: 3 years
- Timeline to get the approval: 30-40 days