API Source Validation
To start the business development of APIs in Bangladesh, you should have the source validation registration in DGDA Database. DGDA stands for Directorate General of Drug Administration, responsible for control and regulate the pharma and medical device industry of Bangladesh.
A local representative/Local agent/Local indenting firm is mandatory for holding the registration (i.e., API Source validation) in Bangladesh.
In Bangladesh, commercial importers/traders are not allowed to import active pharmaceutical ingredients (APIs). Only the finished formulators having the Drug Manufacturing License (issued by DGDA) are allowed to import APIs with their industrial IRC. IRC means Import registration certificate. Indenting firms are the commissioning agents for promoting the APIs to the Bangladeshi Pharmaceuticals for finished dosage form production. A local representative/indenting firm/local entity is required to apply the source validation of APIs in Directorate General of Drug Administration (DGDA), Bangladesh. Usually, source validation process takes 30 working days to get the source validation certificate issued by DGDA. Without having the source validation of the API plant & the APIs in the DGDA database, Bangladeshi purchase managers can not select the API during the Block list preparation. Block list is a format of DGDA to get prior approval of raw materials for import into Bangladesh.
Pharma DRA is the RA partner of:
- Hetero Drugs Ltd., India
- Hetero Labs Ltd., Unit-III, AP, India
- Chemeca Drugs Pvt. Ltd., India
- Liford Pharma LLP, Gujarat, India
- Glochem Industries Pvt. Ltd., India
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