India's Anuh Pharma prequalified status suspended by WHO

Laboratory life science work

The World Health Organization (WHO) has suspended Mumbai-based Anuh Pharma as a prequalified supplier of active pharmaceutical ingredients (APIs) pyrazinamide, used to treat tuberculosis, and sulfadoxine, a malaria treatment, in the latest manufacturing-related blow for the firm.

Anuh, in a notice to the Bombay Stock Exchange, said the WHO's action followed a ban by the European Medicines Agency (EMA) for shipping antibiotic APIs from its Boisar site in the western state of Maharashtra, pending an inspection.

"In view of the EDQM suspension, the WHO prequalification authorities have suspended pyrazinamide and sulfadoxine from the WHO list of prequalified APIs until the WHO led inspection," Anuh Pharma said in the notice.

Anuh has previously pledged to fix problems cited at the plant that include failures to adequately detail the sources of antibiotic APIs as well as sourcing one product, azithromycin, from China's Hebei Dongfeng Pharmaceutical--a company banned in 2014 on good manufacturing practice violations from supplying the European Union.

Scores of Indian firms face manufacturing and data collection violations from EU inspectors and the U.S. FDA--mostly for generic medicines that are a crucial part of a supply chain aimed at keeping reimbursement costs in check in developed economies, and meeting demand for lower-cost products in emerging markets.

This also comes after WHO cited Ahmedabad-based Cadila Healthcare in March for rabies vaccine manufacture deficiencies at its Moraiya plant.

- here's the notice to the Bombay Stock Exchange
- and a story from Press Trust of India