The inspection ended with seven observations, none of which were a repeat or related to data integrity, the company said
Shares of pharma major Cipla shed 2 percent intraday on July 22 after the US drug regulator issued seven observations to the Bengaluru facility.
The United States Food and Drug Administration (USFDA) conducted a routine cGMP inspection at the company's API manufacturing facility in Virgonangar, Bengaluru from June 15, 2019 to June 19, 2019.
The inspection ended with seven observations, none of which were a repeat or related to data integrity.
The company in its release said that it will respond to the agency within the stipulated timeline.
On the other hand, InvaGen Pharmaceuticals, Inc., a wholly-owned subsidiary of the company, received final approval for its abbreviated new drug application (ANDA) for Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg from the USFDA.At 0946 hours, Cipla was quoting at Rs 533.15, down Rs 3.70, or 0.69 percent on the BSE.
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