These observations are both product specific and GMP observations related to the manufacturing and quality processes, Cipla said
Cipla shares fell 2.5 percent in the morning trade on April 1 after its Maharashtra unit received eight good manufacturing practices observations from the US health regulator.
The stock was quoting at Rs 518.60, down Rs 10.70, or 2.02 percent on the BSE, at 0915 hours IST.
The US Food and Drug Administration (USFDA) conducted a product specific pre-approval (PAI) and Good Manufacturing Practices (GMP) inspection at company's Kurkumbh plant from March 11 to 20, 2019.
The inspection covered three units at the plant.
"Post the conclusion of the inspection, the company received 8 GMP observations and also received 10 observations pertaining to the PAI for a novel technology product slated for approval beyond 2024," Cipla said in its BSE filing.
These observations are both product specific and GMP observations related to the manufacturing and quality processes, it added. "There are no data integrity (DI) observations."
The company said it is committed to addressing these observations and would submit its response to the agency within the stipulated time.
