Cipla gets 8 USFDA observations for Kurkumbh plant
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.
New Delhi: 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, the company 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, the company said.
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"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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Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at email@example.com Contact no. 011-43720751 To know about our editorial team click here