Alembic Pharma received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for the inspection carried out by them at company's Solid Oral Formulation Facility (F-4) at Jarod, Vadodara.
The USFDA conducted an inspection at the Jarod unit from December 8 to December 16, 2022. This was a pre-approval inspection to cover Solid Oral drug products for which ANDAs were filed by the company with USFDA. The company had also started receiving approvals for manufactured at this facility.
US FDA issues an establishment inspection report (EIR) to an establishment subject to US FDA inspection when the agency decides to close the inspection.
Alembic has a total of five drug product manufacturing facilities and two drug substance manufacturing facilities. All these facilities are inspected and accepted by USFDA.
The Solid Oral Formulation Facility (F-4) unit was issued five procedural observations back in December 2022 by the USFDA awaiting a response on it, Pranav Amin of Alembic Pharma had told CNBC-TV18 on May 8.
In April, US FDA issued Form 483 with two minor procedural observations for Alembic Pharma’s injectable and ophthalmic facility (F-3) in Karkhadi.
Alembic Pharma’s January-March Quarter earnings were marginally better than estimates. The company's US business continued to slow down on a sequential basis. Shares of the company have opened in the green in today’s trade and is trading near the flatline.
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First Published: May 10, 2023 10:02 AM IST
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