Cipla gets no USFDA observations for Indore facility
The US health regulator conducted a post-approval inspection at Cipla Ltd's Indore facility from 13th May to 17th May 2019.
New Delhi: Drug firm Cipla Friday said the US health regulator conducted a post-approval inspection at its Indore facility, and it ended with zero observations.
"We would like to inform you that the USFDA (US Food and Drug Administration) conducted a post-approval inspection at our Indore facility from 13th May to 17th May 2019. The inspection ended with zero observations," the company said in a BSE filing.
However, the company had received 8 observations for the Kurkumbh plant. Medical Dialogues had earlier reported that the company had received eight good manufacturing practices (GMP) observations from the US health regulator for its Kurkumbh facility in Maharashtra. The company had also received 10 observations pertaining to a product-specific pre-approval (PAI) from the same plant.
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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