Cipla gets 8 observations from USFDA for Kurkumbh plant
Summary
Drug major Cipla on 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 …
Continue reading “Cipla gets 8 observations from USFDA for Kurkumbh plant”
Drug major Cipla on 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.
“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.
Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout
3 Mins Read
Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter