Caplin Point Laboratories' arm receives Form 483 with 10 observations from USFDA

Caplin Point Laboratories announced that the US Food and Drug Administration (USFDA) conducted an unannounced inspection of its subsidiary Caplin Steriles' injectable and ophthalmic manufacturing facility in Gummidipoondi, Tamil Nadu.

The inspection was carried out from 13 August 2026 to 21 August 2026. At the conclusion of the inspection, the company received Form 483 containing 10 observations.

The company said that the observations were procedural in nature and did not pertain to data integrity. It also stated that none of the observations were repeat observations.

Caplin Point Laboratories is a fully integrated pharmaceutical company with a strong presence in Latin America. The companys consolidated net profit jumped 18.79% YoY to Rs 176.91 crore in Q1 FY27. Net sales increased 19.63% to Rs 610.36 crore in Q1 FY27 from Rs 510.22 crore in Q1 FY26.

 

The counter increased 1.09% to settle at Rs 2558.10 on Friday, 21 August 2026.

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