Shilpa Medicare gets 15 observations from USFDA

Shilpa Medicare gets 15 observations from USFDA

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USFDA
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Shilpa Medicare has received 15 observations from US Food and Drug Administration (FDA) for the company’s finished dosage formulation facility (sterile and non-sterile) for Jadcherla facility.

“US FDA conducted good manufacturing practices (GMP) inspection of the company’s finished dosage formulation facility (sterile and non-sterile) from 13-25, February 2020,” the company said in a BSE filing.

The facility is located at S-20 to S-26, pharmaceutical formulations SEZ, TSIIC, Jadcherla, Telangana State, India.

Also read: Alkem Labs gets two USFDA observations

The company is preparing responses to the observations, which will be submitted to the agency within 15 business days.

The company is committed to addressing these observations promptly.

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