Category: EMA

Malta Medicines Authority Maintains cGMP

Pune based Akriti Pharmaceuticals Private Limited’s EUGMP Certificate remains suspended as the facility remains in

EMA To Review Finasteride and Dutasterid

The European Medicines Agency (EMA) has initiated a review of finasteride and dutasteride due to

USFDA and EMA Parallel Scientific Advice

Prospective applicants of Complex Generics (CG) can request for a joint meeting with FDA OGD

EMA Updates Nitrosamines Q&A documen

EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits