The update follows the US FDA inspection conducted at the facility from April 20, 2026, to May 1, 2026, during which the company received a Form FDA 483 containing seven observations. Alkem said the US FDA has now classified the inspection status of the facility as OAI.
The company said it continues to manufacture and supply approved products from the Amaliya facility to the US market. The company added that it will work with the regulator to achieve fully compliant status.
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What is a Form 483
A Form 483 is a list of observations made during the inspection and is issued by the USFDA inspectors after the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. But a Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.
Post Form 483 is issued, the company is given 15 days to submit its response to the USFDA explaining what steps the company will take to resolve the observations made by the USFDA.
What is Official Action Indicated (OAI)?
Given if violations found on-site require further administrative sanctions and mandatory corrective actions.
Fourth Quarter Results
Alkem Laboratories reported a 4.26% year-on-year rise in net profit at ₹306 crore for Q4FY25, falling short of the CNBC-TV18 poll estimate of ₹400 crore. Revenue for the quarter rose 7.1% YoY to ₹3,144 crore, slightly below the poll forecast of ₹3,149 crore.
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EBITDA came in at ₹391.5 crore, down 2.6% from ₹402 crore a year ago, and significantly below the expected ₹499 crore. The operating margin stood at 12.45%, lower than 13.69% in the same period last year and well below the street estimate of 16%.
CEO Vikas Gupta said the company ended the year on a strong note. “Our domestic business continues to gain momentum, reinforcing our confidence in its long-term growth trajectory,” he said, highlighting strong execution and targeted initiatives.
In the India market, Alkem registered 6.5% YoY growth in Q4, slightly trailing the broader Indian Pharmaceutical Market’s 6.9%. However, its acute segment outpaced the market, growing 7.5%, or 150 basis points ahead of the IPM.
International business sales grew 7.2% YoY. The US contributed 19.6% to total sales, down from 21.6% a year ago, while non-US international markets rose to an 11.8% share from 9.9% in Q4 FY24. During the quarter, Alkem filed six ANDAs and received four approvals from the USFDA.
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The company recommended a final dividend of ₹8 per equity share and scheduled its AGM for 25 August 2025, with the record date fixed as 8 August. The dividend, if approved, will be paid from 29 August.
Shares of Alkem Laboratories Ltd ended at ₹5,609.00, down by ₹53.75, or 0.95%, on the BSE.
