Alembic Pharma targets 10-12 product filings from Karkhadi facility

Resolution of the observations made by the USFDA (for which Alembic has already responded to the regulator) is critical for Alembic's US business

Vadodara based drug maker Alembic Pharmaceuticals is now running exhibit batches at its Karkhadi facility (F3) to keep the plant alive and humming, while it awaits a final go-ahead from the US drug regulator.

“This way, once the plant is cleared by the US Food and Drug Administration (USFDA) we will be able to file applications for double the number of products than we would have usually. Typically, we would have been able to do four to six filings in a year from the Karkhadi plant, but as we are keeping the plant alive and humming with exhibit batches, we