Strides Pharma Science Ltd Receives USFDA Establishment Inspection Report for Chestnut Ridge Facility

Strides Pharma Science Ltd, a leading global pharmaceutical company, confirmed that its wholly-owned US subsidiary, Strides Pharma Inc., has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its formulations facility at Chestnut Ridge, New York.

The inspection, conducted between December 17–23, 2025, was a routine current Good Manufacturing Practices (cGMP) audit. While the USFDA issued a Form 483 with four procedural observations, the company emphasized that these were minor in nature and would not affect the supply of commercial products.

This development reinforces Strides’ commitment to maintaining high-quality standards and regulatory compliance across its global manufacturing network.

Key Highlights

• Inspection Period: December 17–23, 2025.
• Facility: Chestnut Ridge, New York (formulations unit).
• Outcome: USFDA issued EIR with four procedural observations.
• Impact: No disruption to product supply expected.
• Significance: Strengthens Strides’ regulatory standing in the US market.
• Market Reaction: Shares dipped slightly post-inspection but outlook remains stable.

Sources: IPP Bureau; CNBC-TV18; The Financial Express