Cipla gets 8 observations from USFDA for Kurkumbh plant

Drug major Cipla Sunday said it has received eight good manufacturing practices (GMP) observations from the US health regulator for its Kurkumbh facility in Maharashtra.

The company has also received 10 observations pertaining to a product specific pre-approval (PAI) from the same plant, Cipla said in a BSE filing.

"The United States Food and Drug Administration (USFDA) conducted a product specific pre-approval (PAI) and Good Manufacturing Practices (GMP) inspection at Kurkumbh plant from March 11, 2019 to March 20, 2019," it added.

The inspection covered three units at the plant. Post the conclusion of the inspection, the company received 8 GMP observations. The company also received 10 observations pertaining to the PAI for a novel technology product slated for approval beyond 2024, Cipla said.

"These observations are both product specific and GMP observations related to the manufacturing and quality processes," it added.

There are no data integrity observations, Cipla said. It, however, did not specify the details of the observations.

"The company is committed to addressing these observations and will submit its response to the agency within the stipulated time," the drug major said.

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