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Cipla gets 8 observations from USFDA for Kurkumbh plant 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.

Press Trust of India  |  New Delhi 

Cipla, Cipla logo, Cipla headquarters

Drug Sunday said it has received eight good practices (GMP) observations from the US regulator for its in

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

"The Food and Drug Administration (USFDA) conducted a product specific pre-approval (PAI) and Good Practices (GMP) inspection at 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 slated for approval beyond 2024, said.

"These observations are both product specific and GMP observations related to the 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 said.

First Published: Sun, March 31 2019. 21:15 IST
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