The USFDA has issued an Establishment Inspection Report (EIR) and communicated the closure of the inspection, the company said in a regulatory filing. The inspection at Alembic Pharmaceuticals’ bioequivalence facility was conducted between March 3 and March 7, 2025.
The latest update follows Alembic Pharmaceuticals’ earlier intimation dated March 7, 2025, regarding the completion of the USFDA inspection at the Vadodara facility.
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What is an Establishment Inspection Report (EIR)?
Based on the inspection and the response given by the company to the USFDA, the FDA will release an Establishment Inspection Report (EIR) within 30 days of the inspection.
The EIR reflects the FDA’s official determination of a factory’s GMP compliance. FDA and the Inspection Classification Database classify the inspection by each project area with one of three classifications.
First Quarter Results
The drugmaker’s net profit grew by 11.7% to ₹172 crore from ₹154 crore last year. Its revenue increased 26% in the first quarter to ₹2,150 crore from ₹1,710 crore in the previous fiscal year.
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Earnings before interest, taxes, depreciation and amortisation (EBITDA) increased 18.6% to ₹333 crore from ₹280.5 crore in the first quarter last year. However, its margins contracted to 15.5% from 16.4% in the year-ago period.
For the India business, Gynaecology, Gastrology and Ophthalmology all showed robust growth, according to the company, while the performance of the animal healthcare business was “encouraging”.
Its US formulation business growth was up 49% from the previous fiscal year, driven by key product launches and volumes. Excluding the US formulations, its growth was 17%, with continued focus on expanding offerings and strengthening market reach, the company said.
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Alembic Pharma said its post R&D EBITDA increased 21% from the previous year. It was supported by operating leverage expansion amid planned strategic expansion in the US branded business and R&D pipeline focusing on peptide development, and increased filings.
Shares of Alembic Pharmaceuticals Ltd ended at ₹823.15, down by ₹0.70, or 0.085%, on the BSE.
