After the United States Food and Drug Administration (USFDA) issued three minor observations towards Bliss GVS Pharma, the company’s share declined by 3.4% in early trade.
The company said the USFDA conducted a good manufacturing practice (GMP) inspection and a pre-approval inspection (PAI) at Bliss GVS Pharma’s manufacturing unit at Palghar from March 13 to 17 in an exchange filing on Saturday, according to a press release.
The USFDA issued a form 483 with three minor observations. The pharma company mentioned that the observations are procedural and unrelated to data integrity. The company plans to prepare a detailed response to these observations to be submitted to the USFDA within the prescribed timelines.
Bliss GVS Pharma develops, manufactures and sells formulations in capsules, tablets, syrups, suppositories, and pessaries under over 250 brands. The formulations are made to work against various illnesses, including malaria and diabetes, and are mainly sold in Africa. At 9:55 am, Bliss GVS Pharma quoted Rs 72.60, down Rs 2.55, or 3.39%, on the BSE.
The company had a net loss of Rs 50.11 crore in the quarter that ended December 2021, which has grown to a consolidated net profit of Rs 27.94 crore in the quarter that ended December 2022. However, the sales declined to Rs 205.72 crore in Q3FY23, 4.87% from Q3FY22.
The company has assured commitment to maintain the highest compliance standards and to work closely with the agency to comprehensively address all the observations.