Shilpa Medicare’s Subsidiary Clears USFDA Inspection at Raichur Facility

Shilpa Medicare announced on Friday, March 14, that its wholly owned subsidiary, Shilpa Pharma Lifesciences Ltd, has successfully cleared a US Food and Drug Administration (USFDA) inspection at its Unit-2 facility in Raichur with zero observations.

The inspection, conducted from March 10 to March 14, 2025, concluded without any Form 483 being issued. This marks the second consecutive clean inspection at this site. “This is to inform you that the United States Food and Drug Administration (USFDA) has conducted an inspection at Unit-2 of Shilpa Pharma Lifesciences Limited, located at Raichur, from March 10-14, 2025. The inspection was closed with ZERO observations. This is the second consecutive ZERO 483 inspection from USFDA at this site,” Shilpa Medicare stated in a regulatory filing.

Recent Inspection at Unit-1

Before this, the USFDA also completed an inspection at Unit-1 of Shilpa Pharma Lifesciences Ltd in Raichur. The inspection, conducted from March 3 to March 7, 2025, resulted in one procedural observation under Form 483.

“This is to inform you that the United States Food and Drug Administration (USFDA) has conducted an inspection at Unit-1 of Shilpa Pharma Lifesciences Limited, located at Raichur, from March 3-7, 2025. On the conclusion of the inspection, we received 1 (one) observation in Form 483, which is procedural in nature,” the company stated in its regulatory filing.

Company’s Response to Observation

Shilpa Medicare assured that it will work closely with the USFDA to address the observation within the stipulated timeframe. “The company will closely work with the agency and remain committed to addressing this observation comprehensively within the stipulated time,” it added.

Stock Performance 

On March 17, 2025, Shilpa Medicare share price traded 0.21% higher at ₹630.05 at 11:19 AM (IST). Shilpa Medicare’s share price reached a 52-week high of ₹959.95, and a 52-week low of ₹403.05. As per BSE, the total traded volume for the stock stood at 0.13 lakh shares with a turnover of ₹79.90 lakhs.

At the current price, Shilpa Medicare shares are trading at a price-to-earnings (P/E) ratio of 72.75x, based on its trailing 12-month earnings per share (EPS) of ₹8.66, and a price-to-book (P/B) ratio of 2.29, according to exchange data.

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