Another Indian drugmaker cleared to produce TB drugs

Even as a new vaccine is set to change the face of tuberculosis prevention, the TB Alliance has given the green light to Indian company Macleods Pharmaceuticals to manufacture the drug pretomanid, used to treat highly drug-resistant TB and as part of a regimen along with bedaquiline and linezolid, reports The Pharma Letter’s India correspondent.

This is the second generic company that has been given permission to manufacture the drug. The TB Alliance had granted rights to US drugmaker Mylan (Nasdaq: MYL) in April.

TB Alliance, the non-profit product development partnership and the generic manufacturer have agreed to produce the new TB drug for countries with high incidence of TB. However, manufacture of bedaquiline in India hit a wall recently. India is accessing the drug solely through the Bedaquiline Donation Program, a collaboration between the US Agency for International Development and American pharma giant Johnson & Johnson (NYSE: JNJ), which currently holds the patent for the drug.