Generic Pharmaceutical Drugs
Branded and generic drugs are technically same but in appearance and pricing. Their similarities and differences are described here in detail. When a drug company first invents a drug, only that company is allowed to make that drug in the same country for a certain number ...
Generic drug manufacturer must gain FDA approval for selling drug in USA, though they do not need to repeat the clinical trials of the reference listed drug (RLD) they copy.The application for generic drugs approval in USA is the Abbreviated New Drug Application (ANDA). It’s called “abbreviated” ...
– Obtain project proposal from project management department
– Perform literature review and request to the TSD/SCM for RLD/ Reference/ Market sample
– Raise requisition for new API, excipients, packaging materials and analytical requirements to TSD/SCM
– Perform RLD/ Reference/ ...