WHO prequalifies Mylan's India unit to supply TB drug API

By Gareth Macdonald

- Last updated on GMT


Related tags Active pharmaceutical ingredient Pharmacology Pharmaceutical drug Tuberculosis

The WHO has prequalified Indian-based Mylan Laboratories Ltd to supply the tuberculosis drug ingredient protionamide.

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.

TB ingredients

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.

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...