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Alembic Pharma completes USFDA inspection at Karakhadi, Gujarat facility with two observationsShares of Alembic Pharmaceuticals Ltd ended at ₹773.70, down by ₹2.70, or 0.35%, on the BSE.By Jomy Jos Pullokaran  February 18, 2026, 11:42:26 PM IST (Published)2 Min ReadDrug firm Alembic Pharmaceuticals Ltd on Wednesday (February 18) completed an unannounced cGMP inspection by the United States Food and Drug Administration (USFDA) at its injectable facility (F-3) in Karakhadi, Gujarat. The inspection was conducted from February 9 to February 18, 2026.

The USFDA inspection concluded with two observations. None of the observations are related to data integrity. The company will respond to the observations within the stipulated time. Alembic Pharmaceuticals continues to maintain its commitment to high-quality standards and regulatory compliance.

Third Quarter Results

Net profit declined 4.1% year-on-year to ₹132 crore, impacted by a one-time provision of ₹42 crore towards employee benefits following changes under the new labour code.

Also Read: Alembic Pharma secures USFDA final nod for Parkinson’s therapy tablets

The company posted a 10.8% year-on-year increase in revenue to ₹1,876.3 crore, driven by steady performance across domestic and international operations. EBITDA rose 12.8% to ₹293.5 crore, with margins inching up to 15.6% from 15.4% in the same period last year.

The India-branded business posted 6% year-on-year growth to ₹652 crore, led by the gynaecology, ophthalmology and animal healthcare segments. The anti-infective portfolio grew broadly in line with market trends, while the company also introduced four new products during the quarter.

Internationally, US generics revenue rose 6% to ₹553 crore, with two new product launches during the quarter. Ex-US international generics saw strong momentum, growing 36% year-on-year to ₹406 crore. Alembic received seven ANDA approvals during the quarter, taking cumulative approvals to 232.

Also Read: Alembic Pharma receives final US FDA approval for eye inflammation drug

The API business grew 2% year-on-year to ₹264 crore. Managing Director Pranav Amin said the company maintained its operating rhythm, invested around 9% of revenue in R&D, and made progress on integrating Utility Therapeutics, with the launch of Pivya™ expected in Q4 to strengthen its US branded portfolio.

Shares of Alembic Pharmaceuticals Ltd ended at ₹773.70, down by ₹2.70, or 0.35%, on the BSE.Continue Reading(Edited by : Jomy Jos Pullokaran)TagsAlembic Pharmaceuticalsshare market today