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Granules India gets Establishment Inspection Report from USFDA

Granules India gets Establishment Inspection Report from USFDA

NEW DELHI: Pharma firm Granules India has received Establishment Inspection Report from the US health regulator for the inspection done at the company’s Jeedimetla plant in Telangana.

“The company has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (USFDA) for the inspection conducted at its Jeedimetla facility in December 2015,” Granules India said in a filing to the BSE.

The USFDA acknowledged receipt of responses sent on January 7 and March 28, 2016 on the observations issued by the FDA for the facility, it added.

“The USFDA closed the matter and issued the EIR for the Jeedimetla facility…,” Granules India said.

In December 2015, Granules India had said in a regulatory filing that USFDA had completed the inspection of its two facilities, one located at Vizag in Andhra Pradesh and another at Jeedimetla in Telangana.

“There are no observations for Vizag facility and three observations for Jeedimetla facility. The company will respond to the observations in 15 business days,” it had added.

The Hyderabad-based firm serves customers in over 60 countries and has manufacturing footprint in India and China.

Source: PTI
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