Shilpa Medicare gets 2 USFDA observations for Telangana facility

The US Food and Drug Administration (USFDA) inspected the company's finished dosage formulation facility located at Pharmaceutical Formulations SEZ, APIIC, Jadcherla (Telangana state) from August 29 to September 6, 2019, Shilpa Medicare said in a filing to the BSE.

New Delhi: Drug firm Shilpa Medicare on Saturday said it has received two observations from the US health regulator for its Telangana facility.

The US Food and Drug Administration (USFDA) inspected the company's finished dosage formulation facility located at Pharmaceutical Formulations SEZ, APIIC, Jadcherla (Telangana state) from August 29 to September 6, 2019, Shilpa Medicare said in a filing to the BSE.

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"The inspection concluded with two observations. There were no repeat observations or Data Integrity (DI) related observations," the company added.

Shilpa Medicare said the company is addressing these observations and will respond to the USFDA at the earliest.

Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989.

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