The World Health Organisation (WHO) decision follows an inspection of a facility in Patancheru, Telangana at which the firm – a unit of Netherlands-based Mylan NV – produces the active pharmaceutical ingredient (API).
The WHO said: “Good-quality APIs are vital to the production of good-quality medicines. WHO prequalification of APIs facilitates production of quality medicines by identifying such APIs for use by manufacturers of finished pharmaceutical products (FPPs).”
Firms seeking prequalification must submit an active pharmaceutical ingredient master files (APIMF) for WHO review and have their sites inspected. Those that pass are included on a list maintained by the WHO that drug industry customers and regulators can access.
Protionamide – which is also known as prothionamide - is a thioamide. It is used to treat tuberculosis and leprosy.
Mylan is the first supplier to be prequalified to produce the API by the WHO, which had been looking for a source since 2014.
The WHO’s search for tuberculosis ingredient suppliers intensified in 2016 after it published a report criticizing the drug industry for not playing a substantial role in combatting the spread of resistant forms of the disease.
In addition to calling for requalification applications from potential API suppliers, the Geneva, Switzerland-based agency expanded the list of ingredients for which it would accept applications.