1. Generics Bulletin

The Factory Floor: Biocon, Indoco, Strides And Lupin Line Up For Inspection

As MedPharm Completes Expansion And Coripharma Concludes Packaging Deal

 
• By Penelope MacRae

Biocon Pharma’s solid-dosage plant has received FDA inspection approval but its parent company was not so lucky, with one of its sites getting hit with five observations. Indoco, Strides, and Lupin were also in the regulatory spotlight while MedPharm has moved into a new, expanded facility and Coripharma has signed a packaging deal with Stada.

GMP
Several firms have seen outcomes from GMP inspections • Source: Shutterstock

January was a busy inspection month for Indian drugmakers with some getting the all-clear from regulators while others were told to do more work.

Biocon announced that the US Food and Drug Administration had conducted a pre-approval and good manufacturing practice inspection from 20-24 June of its Indian active pharmaceutical ingredient plant in Bengaluru that ended with the agency issuing a Form 483 with five observations

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