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.
Read also: Glaucoma drug: USFDA nod to Alembic Pharma Brimonidine Tartrate Ophthalmic Solution
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.
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