Alembic Pharmaceuticals has announced that it has received the EIR from the USFDA

Alembic Pharmaceuticals has announced that it has received the Establishment Inspection Report (EIR) from the USFDA for its API-III manufacturing facility located in Karakhadi, Gujarat. The USFDA inspection was conducted from 17 March 2025 to 21 March 2025. Alembic had so far active 141 DMFs. There is a high likelihood that approximately 41 DMFs listed below could have been manufactured at the Karakhadi site.


API business could account for about 20% of Alembic's overall business, and therefore, the Karakhadi site would make a significant contribution to Alembic’s presence in the United States.


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