Alembic Pharma gets USFDA EIR for Jarod facility

Published On 2023-05-10 06:02 GMT | Update On 2023-05-10 06:02 GMT

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.

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.

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.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Alembic Pharma gets USFDA EIR for Jarod facility

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