API Source Validation

Documents required:

  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
  • Timeline to get the approval: 30-40 days