The drug major on Thursday announced that it has received a communication from the United States Food and Drug Administration (USFDA) that the classification of company's Goa manufacturing facility continues to be as Official Action Indicated (OAI).
Earlier in August 2022, the pharmaceutical company said that its Goa plant underwent a USFDA inspection from 16 to 26 August 2022. The US drug regulator had inspected the company's Goa manufacturing facility in September 2019. A warning letter for the same was received by the company in February 2020. On conclusion of the inspection, the company had received 6 observations with some referencing to the observations made during the September 2019 inspection, it added.
USFDA may continue to withhold product approvals from this facility till the outstanding observations are resolved. The company has an ongoing derisking plan in place for new product approvals, the drug maker stated.
Further the company added that it will work closely with the USFDA and is committed to address these within the stipulated time.
Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets.
The pharma major's consolidated net profit rose 10.9% to Rs 788.90 crore on 5.59% increase in total revenue from operations to Rs 5,828.54 crore in Q2 FY23 over Q2 FY22.
Shares of Cipla rose 0.02% to Rs 1,107.45 on the BSE.
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