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Alembic Pharma receives EIR from US FDA for solid oral formulation facility at Jarod

Alembic Pharma receives EIR from US FDA for solid oral formulation facility at Jarod

Alembic Pharmaceuticals has received Establishment Inspection Report (EIR) from US Food and Drug Administration (US FDA) for the inspection carried out by them at our Solid Oral Formulation Facility (F-4) at Jarod, Vadodara during the period from December 6 to 16, 2022. This was a pre-approval inspection to cover our Solid Oral drug products for which ANDAs were filed with the US FDA. The Company had also started receiving approvals for manufacturing at this facility.

Alembic has a total of five drug product manufacturing facilities and two drug substance manufacturing facilities. All these facilities are inspected and accepted by the US FDA.

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Alembic Pharma EIR USFDA
More news about: quality / gmp | Published by Sudeep Soparkar | May - 11 - 2023 | 411

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