First Pharmacy UK

Tag: generic drug approval

4 Feb

From ANDA to Shelf: How Generic Drugs Reach Retail Pharmacies
Discover how generic drugs go from FDA approval to your pharmacy shelf, including regulatory hurdles, manufacturing challenges, and distribution logistics. Learn why some generics take months to become available despite approval.

By: Wellington Osawe 4 Comments Read More
28 Dec

Deficiency Letters in Generic Applications: Common FDA Findings and How to Avoid Them
Deficiency letters from the FDA are the most common reason generic drug applications are delayed. Learn the top 5 findings-dissolution issues, impurities, sameness problems, CQAs, and bioequivalence errors-and how to avoid them before submitting your ANDA.

By: Wellington Osawe 10 Comments Read More