Shilpa Medicare’s subsidiary clears USFDA inspection with zero observations for second consecutive time

Shilpa Medicare Limited has announced that the United States Food and Drug Administration (USFDA) has successfully completed an inspection at Unit-2 of Shilpa Pharma Lifesciences Limited, a wholly owned subsidiary of the company, located in Raichur. The inspection, conducted between March 10 and March 14, 2025, concluded with zero observations.

This marks the second consecutive instance where the facility has received a clean review with no Form 483 observations, reinforcing the company’s commitment to maintaining high regulatory and compliance standards. A USFDA inspection with zero observations is a significant achievement, reflecting adherence to stringent quality control and manufacturing processes.

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Shilpa Medicare remains focused on ensuring global regulatory compliance across its facilities, strengthening its position in the pharmaceutical industry. The successful inspection further enhances the credibility of the company’s operations in the US market.