Cipla said that the US FDA has issued six observations following the inspection conducted in August 2022 at its Goa plant.
The drug maker said that the Goa plant recently underwent a United States Food and Drug Administration (US FDA) inspection from 16th - 26th August 2022. The US FDA 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.
Cipla further informed that on conclusion of the inspection, the company has now received 6 observations with some referencing to the observations made during the September 2019 inspection. There are no data integrity observations.
"The company will work closely with the US FDA and is committed to address these within the stipulated time, Cipla said in a statement.
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 company's consolidated net profit slipped 4% to Rs 686.40 crore on 2.3% decline in total revenue from operations to Rs 5,375.19 crore in Q1 FY23 over Q1 FY22.
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