Shares of Alkem Laboratories are likely to remain in focus after the US Food and Drug Administration (USFDA) classified the company’s Amaliya manufacturing facility in Daman as Official Action Indicated (OAI).

The development follows seven observations issued after a US FDA inspection earlier this year, putting the stock under regulatory watch.

The USFDA inspected the Daman facility between April 20 and May 1, 2026. At the end of the inspection, the regulator issued a Form 483 containing seven observations. Alkem had earlier said it would respond to the observations within the required timeline.

The latest OAI classification means the US regulator has identified issues that require further regulatory attention. It does not automatically mean that supplies from the facility have been stopped. Alkem has said that it continues to manufacture and supply approved products from the facility to the US market and is working with the regulator to address the concerns.

The development is important because regulatory clearances from the USFDA are closely watched by investors in Indian pharmaceutical companies. Any prolonged delay in resolving the observations could create uncertainty around future approvals or supplies from the facility.

Alkem, meanwhile, has several other business initiatives underway. The company is investing in manufacturing capacity and expanding into areas such as medical devices. It has also scheduled its board meeting for August 14 to announce its June-quarter financial results.

At 12:15 pm, the shares of Alkem Laboratories were trading 0.31% lower at Rs 5,580 on NSE.

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