Caplin Point Unit Passes FDA Inspection with Zero 483 Observations

Caplin Point Laboratories Ltd., established in 1990, is a distinguished Indian pharmaceutical enterprise specialising in the development, manufacture, and marketing of generic formulations and branded products. 

Caplin Point gets EIR from the US FDA

On January 6, 2025, Caplin Point Laboratories Ltd. announced a significant milestone, having received the coveted Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA). This follows a comprehensive review of its Caplin Steriles injectable and ophthalmic manufacturing facility, situated in Gummidipoondi, Tamil Nadu.

“The company has been granted the Establishment Inspection Report (EIR) by the U.S. FDA, affirming compliance with regulatory standards after the recent inspection of the Caplin Steriles facility at Gummidipoondi,” Caplin Point Laboratories disclosed in its regulatory filing.

About Inspection

The inspection, conducted on an unannounced basis from August 5, 2024, to August 9, 2024, concluded with a pristine outcome of zero Form 483 observations. This result reinforces the company’s commitment to adhering to stringent quality and regulatory standards. Notably, Caplin Point promptly informed the stock exchanges of the inspection’s successful completion on August 9, 2024.

The FDA’s routine inspections aim to evaluate facilities for adherence to Good Manufacturing Practices (GMP) and other regulatory protocols critical to ensuring the quality, safety, and efficacy of pharmaceutical products.

Share Price Performance

As of 10:43 AM on January 6, 2025, shares of Caplin Point Laboratories Ltd were trading at ₹2,548.00 on the National Stock Exchange (NSE).

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