We are looking for a vendor to outsource API--BALSALAZIDE DISODIUM DIHYDRATE for the US market.
The tentative quantity requirement for development-10Kg, EB-250Kg approx.
Kindly provide the below details for vendor evaluation purpose:
1. USFDA DMF Review status. (when was it last reviewed for this API-- month/ year)
2. USFDA Inspection status. (Date, Month, EIR status)
3. Is the API sold commercially in the US?
4. How many ANDA players do you work with presently?
5. Slab wise- Developmental & Commercial Price of the API