Benefits of having API registration with 3rd party AR in Bangladesh
A local representative/Local agent/Local indenting firm is mandatory for holding the registration (i.e., API Source validation) in Bangladesh.
Definitions:
End user of APIs = Finished medicine manufacturer in Bangladesh
Indenting firm = Local agent for promoting and getting orders from the end user. Indenting firm/indentor takes commission on sale/export value.
Traders = importers. If any importer/trading firm import APIs from foreign API manufacturers, it’s illegal.
Bangladesh Government (DGDA) allows API import by the “End User” only (who have finished medicine manufacturing License/plants).
We are the source validation registration holder of the following API manufacturers:
- Glochem Industries Pvt. Ltd., Hyderabad, India
- Chemeca Drugs Pvt. Ltd., AP, India
- Liford Pharma LLP, Gujarat, India;
- Hetero Drugs Ltd., Hyderabad, India
- Kudos Chemie, India
1. If we hold the registration of your APIs in DGDA (Directorate General of Drug Administration), then DGDA database shows your API names & manufacturer’s name for preparing the order/Block list by the purchase managers of Bangladeshi formulators.
2. You can appoint multiple local agent/indenting firm for specific/targeted Pharmaceuticals in Bangladesh.
3. Local agent/indenting firms do not handover the Original reg. certificates (i.e., source validation certificate) after business discontinuation.
4. We charge very nominal yearly registration holding fees per APIs. We do not ask for the commission on the PI value.
5. Principal (Manufacturer) can export directly to finished medicine formulators (e.g. Square Pharma, Incepta, BEXIMCO, Popular Pharma etc.)
6. We will hand over the Registration certificate to new local agent anytime if manufacturer wants. Only the current year’s Reg. holding fees should be paid.
7. We will provide you the contact person name & address of purchase department.
8. We will visit the purchase department of Bangladeshi clients along with you, if you visit 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 cannot 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.
Other related services:
(a) We provide dedicated Business development executive for your product promotion to the Local pharmaceuticals.
(b) You can use our office as your country office located in Dhaka.
(c) Payroll management/HR service for your Bangladesh employee.
(d) We will submit your COA/Sample/Price quotation to the Pharma companies in person.
