Rosuvastatin Calcium API 1 Kg with DMF - NPD

Air Pharmaceuticals invites quotations for 1 Kg Rosuvastatin Calcium API for new product development (NPD). Shipment CPT Lahore by air. Payment: Bank Contract (BC).

The following documents are required with the quotation (or before PO):
1. DMF - open part / applicant part (and Letter of Access / authorization for DRAP registration)
2. Certificate of Analysis (COA) of current batch
3. Method of Analysis (MOA) and specifications
4. Stability data (accelerated and long term)
5. GMP certificate of manufacturing site
6. Manufacturing license of the manufacturer
7. MSDS / SDS
8. Impurity profile, residual solvents and nitrosamine risk assessment
9. TSE / BSE and allergen statements
10. Working / reference standard and impurity standards availability
11. Manufacturer name and site address; authorization letter if quoting as indenter / agent
12. Form 3
13. Form 7 (manufacturer warranty)
14. Certificate of Origin (COO)
15. FTA certificate of origin (China - Pakistan FTA) for duty concession, if shipped from China

1. Prices must be quoted inclusive of all taxes unless stated otherwise.
2. Quotation must remain valid for at least 30 days.
3. Air Pharmaceuticals reserves the right to accept or reject any quotation in full or in part without assigning any reason.
4. Partial quotations are accepted unless stated otherwise.

No clarifications published yet.