Alembic Pharma gets USFDA EIR for Jarod facility
Vadodara: Pharma major, Alembic Pharmaceuticals, has announced that the Company has received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for the inspection carried out at the company's Solid Oral Formulation Facility (F-4) at Jarod, Vadodara.
The inspection was held from 8th December, 2022 to 16th December, 2022.
"This was pre-approval inspection to cover our Solid Oral drug products for which ANDAs were filed with USFDA. The Company had also started receiving approvals manufactured at this facility," Alembic stated in a BSE filing.
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.
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Medical Dialogues team had earlier reported that Alembic Pharma had received a Form 483 with 5 procedural observations from USFDA after an inspection of the company's said facility.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Read also: USFDA inspection: Alembic Pharma gets Form 483 with 5 observations
Headquartered in Vadodara, Gujarat, Alembic Pharmaceuticals Limited is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. The company was founded in 1907. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
Read also: Alembic Pharma successfully completes ANVISA, Brazil GMP audit for API-III facility at Karakhadi
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