Strides Pharma US Unit Gets FDA Form 483 with 4 Observations; Company Confident

• US FDA inspected Strides Pharma Science's wholly-owned subsidiary, Strides Pharma Inc (SPI), at its Chestnut Ridge, New York plant from Dec 17-23, 2025.
• The inspection concluded with the issuance of Form 483, noting four observations.
• Strides Pharma stated it was a routine inspection and the observations are not expected to impact product supply.
• The company will submit a detailed response to the FDA and is confident in addressing all observations satisfactorily.
• Strides Pharma reported strong Q2 results with net profit up 82% to ₹131.5 crore and revenue up 4.6% to ₹1,221 crore.

Why It Matters: Strides Pharma's US unit received 4 FDA observations but assures no impact on supply, showing strong Q2 results.