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(08 Mar 2025, 11:19)

Shilpa Medicare's Raichur units gets Form 483 with one observation from US FDA

Shilpa Medicare said that the United States Food and Drugs Administration (US FDA), post an inspection, has issued Form 483 with one observation to the company’s unit located at Raichur.


In a regulatory filing made after market hours yesterday, the company stated that the United States Food and Drugs Administration (USFDA) had conducted an inspection at Unit-1 of Shilpa Pharma Lifesciences, located at Raichur from March 3-7, 2025.

On conclusion of inspection, we received one observation in form 483, which is procedural in nature.

"The company will closely work with the agency and remain committed to address this observation comprehensively within stipulated time," Shilpa Medicare stated.

Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India.

The company had reported consolidated net profit of Rs 31.78 crore in Q3 FY25, which is significantly higher as compared with the PAT of Rs 4.58 crore posted in Q3 FY24. Revenue from operations for the third quarter was at Rs 319.32 crore, up 11.35% year on year.

The scrip had added 1.68% to end at Rs 671.95 on the BSE yesterday.


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