Lupin announced that the U.S. Food and Drug Administration (FDA) has classified its Pithampur Unit-2 manufacturing facility as “Official Action Indicated” (OAI) following an inspection conducted between 8 and 17 July 2025. The inspection resulted in a Form 483 with four observations, leading to the upgraded regulatory status.

An OAI designation means the FDA has identified deficiencies that may warrant formal enforcement or regulatory action unless the company implements adequate corrective measures. Lupin stated that it is actively engaging with the U.S. regulator and remains committed to maintaining full compliance with current Good Manufacturing Practice (cGMP) standards across all its manufacturing sites.

The Pithampur Unit-2 facility is responsible for producing oral solid dosage forms and ophthalmic products, making the regulatory action particularly significant for Lupin’s exports to regulated markets such as the United States. Under the OAI status, the site may face restrictions on new product approvals until the observed issues are satisfactorily resolved.

Analysts have noted that any delay in addressing the regulatory findings could disrupt production timelines, impact supply continuity, and increase compliance-related costs for the company. Following the announcement, Lupin’s shares recorded a decline as investors reacted to concerns over the potential implications for its global operations and export revenues.