French inspectors find issues at Indian plant cited earlier by Italy

The European Medicines Agency has cited the Kores API plant in Roha, India. (Pixabay)

French inspectors found a lot they didn’t like about an Indian manufacturer when they inspected its operation for consideration of approving its ambroxol hydrochloride API. The problems led the European Medicines Agency to raise questions about the plant’s production of other active ingredients. 

The recent inspection of the Kores facility in Roha, India, found five major deficiencies. They included problems with data integrity, validation of computers and several issues with risks of contamination or cross-contamination.

The report pointed out that Italian authorities had found the plant out of compliance during an inspection in 2017 and suspended its certificate to produce certain APIs.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

RELATED: EMA blocks products from one of Mercury Laboratories' plants in India

The EMA noted that the plant manufactured more than 15 APIs for treatments that include heart disease, asthma and diabetes. The deficiencies pose the likelihood that those products also could be compromised, the French inspectors pointed out.

The EMA noted data integrity issues with another Indian API maker recently. An inspection of a Mercury Laboratories plant in Jarod, India, found 20 deficiencies, including one critical and six major deficiencies. The critical deficiency was tied to authenticity of manufacturing records. Inspectors said production records and quality risk assessment records could not be verified.

Suggested Articles

The FDA has handed down its decision against Sanofi and Lexicon's Zynquista.

Analysts with Cortellis expect seven blockbuster drug launches in markets across the world this year. AbbVie's upadacitinib leads the pack.

The new Alcon shares will be listed on the Swiss Exchange and the New York Stock Exchange on April 9 under the ticker “ALC.”