Cipla gets 7 USFDA observations for Bengaluru API unit
New Delhi: Drug firm Cipla recently said the US health regulator conducted an inspection at its API manufacturing facility in Virgonangar, Bengaluru and it ended with 7 observations.
The inspection at the facility was conducted from 15th June 2019 to 19th June 2019.
"The United States Food and Drug Administration (USFDA) issued seven observations after conducting a routine 'cGMP inspection' at Cipla's API manufacturing facility in Virgonangar, Bengaluru, the homegrown pharma major said Friday. The inspection was conducted from June 15 to June 19," Cipla said in a regulatory filing.
Also Read: Cipla gets no USFDA observations for Indore facility
Commenting on the same, the company said that it will respond to the agency within the stipulated timeline.
Cipla Limited is a multinational pharmaceutical and biotechnology company, headquartered in Mumbai. The company primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control and depression; other medical conditions.
It was founded by Khwaja Abdul Hamied as ‘The Chemical, Industrial & Pharmaceutical Laboratories’ in 1935 in Mumbai. The name of the Company was changed to ‘Cipla Limited’ on 20 July 1984. In the year 1985, USFDA approved the company’s bulk drug manufacturing facilities.
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