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Granules India facility gets 3 observations during USFDA audit

Granules India facility gets 3 observations during USFDA audit

New Delhi: Drug firm Granules India has received three observations from the USFDA for its Jeedimetla, Hyderabad facility during a recent inspection.

US Food and Drug Administration (USFDA) completed the inspection of company’s two facilities, one located at Vizag in Andhra Pradesh and another at Jeedimetla in Telangana, Granules India said in a regulatory filing.

“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 added.

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

It has three facilities in Hyderabad and one in Jingmen, China. A fifth factory is under construction in Vizag through its JV company Granules OmniChem.

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