Alkem Laboratories US FDA Facility Gets OAI Status

Date: August 6, 2026

Regulatory Update

This disclosure provides an update regarding the US Food and Drug Administration (US FDA) inspection at the company's manufacturing facility located at Amaliya, Daman.

The inspection was conducted from April 20, 2026 to May 1, 2026. During this inspection, the company received a Form FDA 483 containing seven (7) observations, as previously intimated on May 2, 2026.

The US FDA has now classified the inspection status of the facility as Official Action Indicated (OAI).

Despite the OAI classification, the company continues to manufacture and supply approved products from this facility to the U.S. market.

The company stated it will work with the regulator to achieve fully compliant status for the facility.