 "Ipca shares drop nearly 3% after USFDA's 11 observations about MP facility")
Ipca Laboratories' shares dropped 2.57 per cent to end at Rs 715.95 apiece on BSE Friday after USA’s drugs regulator made 11 observations about the pharmaceutical firm’s manufacturing facility in Ratlam, Madhya Pradesh.
The facility plays a crucial role in Ipca's production of active pharmaceutical ingredients (APIs), crucial components of medicines. The United States Food and Drug Administration (USFDA) issued a form with 11 observations about the facility after inspection from June 5 to June 13, 2023.
Ipca has faced several challenges in complying with cGMP (Current Good Manufacturing Practices) regulations set by the USFDA over the years. Reports suggest that USFDA’s letters warned the company that it had failed to meet regulatory standards. Ipca recently received three USFDA observations after an inspection of its formulations manufacturing unit in Piparia, Silvassa, from April 18 to April 26.
Ipca has said it will respond comprehensively to the observations within the specified timeframe.
USFDA’s observations during the inspection in Ratlam listed areas that require attention and improvement in the company's processes. Details of the observations have not been disclosed. Ipca said: “The company takes the quality and compliance issues with utmost importance and remains committed to maintain the highest standards of quality and compliance across all its manufacturing facilities.’’
Zydus Lifesciences, another pharmaceutical company, said on Tuesday its injectables manufacturing facility at Zydus Biotech Park in Changodar, Ahmedabad, underwent USFDA cGMP inspection from June 5 to June 13 June and it was concluded without any observations.