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Cipla receives inspection report from USFDA for Kurkumbh facility


Cipla receives inspection report from USFDA for Kurkumbh facility

The Kurkumbh manufacturing facility was inspected by the United States Food and Drug Administration (USFDA) from March 11 to March 20, 2019, Cipla said in a BSE filing.

New Delhi: Pharma major Cipla Monday said it has received establishment inspection report (EIR) from the US health regulator after inspection of Kurkumbh facility in Maharashtra.

The Kurkumbh manufacturing facility was inspected by the United States Food and Drug Administration (USFDA) from March 11 to March 20, 2019, Cipla said in a BSE filing.

The Kurkumbh site manufactures active pharmaceutical ingredients (API) and formulations and is one of the four sites that the company operates. Many of the company’s pipeline products filed in the US market, reportedly come from this facility.

The company has received the EIR indicating closure of the inspection, it added.

A couple of months ago, Cipla had received eight good manufacturing practices (GMP) observations from the US health regulator for its Kurkumbh facility in Maharashtra. Medical Dialogues had earlier reported that apart from 8 GMP observations, the company had also received 10 observations pertaining to the PAI for a novel technology product slated for approval beyond 2024.

Also Read: Cipla gets 8 USFDA observations for Kurkumbh 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.

Read Also: Cipla to acquire 26 percent stake in AMP Solar Power Systems

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