Cipla gets eight observations from USFDA for Kurkumbh plant

Cipla has recently received eight good manufacturing practices (GMP) observations from the US health regulator for its Kurkumbh facility in Maharashtra. The inspection covered three units at the plant. Post the conclusion of the inspection, the company received eight GMP observations.

The company also received 10 observations pertaining to the PAI for a novel technology product, slated for approval beyond 2024. These observations are both product-specific and GMP observations, related to the manufacturing and quality processes. The company is committed to addressing these observations and will submit its response to the agency within the stipulated time.