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Shilpa Medicare gets 2 observations from USFDA for Telangana facility

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Press Trust of India New Delhi
Last Updated : Sep 07 2019 | 4:40 PM IST

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.

"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.

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First Published: Sep 07 2019 | 4:40 PM IST

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