Wednesday, June 19, 2024

Sun Pharma's Dadra unit gets USFDA warning letter

Sun Pharma's Dadra unit had received an Official Action Indicated (OAI) status from the USFDA on April 11 this year. This was after the regulator had inspected the facility between December 4 to December 15, 2023.

Sun Pharma's Dadra unit is involved in the production of oral solid dosage forms and in the manufacturing of the generic Revlimid, which has been a key driver of sales for many pharma companies including Dr. Reddy's, in recent times.

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EU GMP Chapter 1 Revision: Key Updates and Stakeholder Consultation

The European Commission has announced a targeted revision to Chapter 1 of EudraLex Volume 4, the EU Good Manufacturing Practice (GMP) Guidel...