Another Indian API maker is in trouble over manufacturing issues. This time it is an Artemis Biotech plant in Hyderabad and it is the German drug authority that did the legwork, leading to the recommendation that EU countries not accept the company's simvastatin APIs, plus the possibility its plant certification will be yanked.
The recommendations come in a report posted by the European Medicines Agency (EMA), following a late June visit to the plant by German inspectors. They reported finding nearly three dozen observations, a handful of them major.
Among other issues, the authority reported a “demonstrated a lack of QA oversight” such as keeping important GMP data outside of the quality management system. There were problems with data integrity. It said the plant’s repackaging operations were conducted without any documentation and QA approval.
The report says Artemis Biotech is a division of Themis Medicare, which is a joint venture of India’s Themis and Gedeon Richter of Hungary. Headquartered in Mumbai, the company has manufacturing facilities in Vapi and Haridwar, as well as Hyderabad.
The German drug overseer said the Indian manufacturer’s products don’t need to be recalled, but it did suggest that the Artemis plant not be allowed to ship any more APIs to member countries until problems at the plant are resolved. It said it will be up to the EMA to decide whether to pull its manufacturing certificate.
In 2013, Novartis’ generics division Sandoz pulled two batches of tuberculosis drugs manufactured by Themis Medicare from the market in India after some packages were found to have improper doses in strips of medications.
Western regulators have kept the heat on shortcomings at Indian manufacturers. The EMA and FDA have both taken actions against a number of Indian plants recently. The EMA earlier this year cited a Dhanuka Laboratories facility in Gurgaon, while the FDA last week banned a third Wockhardt manufacturing plant for a variety of problems. Pfizer also acknowledged about a week ago that it had temporarily suspended production at a Hospira plant in Chennai, India, after the FDA found new concerns there.
- access the EMA report here