Alembic Pharmaceuticals completes USFDA inspection at Karakhadi, Gujarat facility with two observations – CNBC TV18

Drug agency Alembic Pharmaceuticals Ltd on Wednesday (February 18) accomplished an unannounced cGMP inspection by america Meals and Drug Administration (USFDA) at its injectable facility (F-3) in Karakhadi, Gujarat. The inspection was carried out from February 9 to February 18, 2026.

The USFDA inspection concluded with two observations. Not one of the observations are associated to information integrity. The corporate will reply to the observations inside the stipulated time. Alembic Pharmaceuticals continues to keep up its dedication to excessive-high quality requirements and regulatory compliance.

Third Quarter Outcomes

Web revenue declined 4.1% yr-on-yr to ₹132 crore, impacted by a one-time provision of ₹42 crore in direction of worker advantages following modifications underneath the brand new labour code.

Additionally Learn: Alembic Pharma secures USFDA remaining nod for Parkinson’s remedy tablets

The corporate posted a ten.8% yr-on-yr improve in income to ₹1,876.3 crore, pushed by regular efficiency throughout home and worldwide operations. EBITDA rose 12.8% to ₹293.5 crore, with margins inching as much as 15.6% from 15.4% in the identical interval final yr.

The India-branded enterprise posted 6% yr-on-yr development to ₹652 crore, led by the gynaecology, ophthalmology and animal healthcare segments. The anti-infective portfolio grew broadly in line with market tendencies, whereas the corporate additionally launched 4 new merchandise in the course of the quarter.

Internationally, US generics income rose 6% to ₹553 crore, with two new product launches in the course of the quarter. Ex-US worldwide generics noticed sturdy momentum, rising 36% yr-on-yr to ₹406 crore. Alembic obtained seven ANDA approvals in the course of the quarter, taking cumulative approvals to 232.

Additionally Learn: Alembic Pharma receives remaining US FDA approval for eye irritation drug

The API enterprise grew 2% yr-on-yr to ₹264 crore. Managing Director Pranav Amin stated the corporate maintained its working rhythm, invested round 9% of income in R&D, and made progress on integrating Utility Therapeutics, with the launch of Pivya™ anticipated in This autumn 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.