Panacea Biotec subsidiary gets OAI from USFDA for Baddi facility

8 Sep 2022 , 02:57 PM

Earlier in June 2022, The United States Food and Drug Administration (USFDA) conducted an inspection at subsidiarys facility at Baddi, Himachal Pradesh from 30 May 2022 to 8 June 2022. At the end of inspection, USFDA issued Form 483 with eight observations which are related to improvements in existing procedures and are addressable. The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved. PBPL is working closely with USFDA to close these observations and the closure of Warning Letter issued by the USFDA earlier on 24 September 2020, the company said. The pharma company said that it is committed to patient safety & quality and take quality & compliance matters seriously and stand by its commitment to fully comply with the cGMP quality standards. PBPL continues to manufacture and distribute existing products for the US market, thereby not likely to have any material adverse impact on current business from the facility, the company stated in press release. Panacea Biotec is a biotechnology company that focuses on discovery, development, and commercialisation of prescription medicines primarily, focusing on vaccines, diabetes, transplant, gastroenterology, and oncology. The company reported a consolidated net loss of Rs 56.14 crore in Q1 FY23 as against a net loss of Rs 57.35 crore recorded in Q1 FY22. Net sales dropped 16.4% year on year to Rs 110.70 crore in Q1 FY23. Shares of Panacea Biotec were down 0.43% to Rs 138.35 on the BSE. Powered by Capital Market – Live News