Removal of antiretroviral products from WHO prequalification

Department of Essential Drugs and Medicines Policy; Department of HIV/AIDS

11 November 2004

Information and guidance for regulatory bodies, national AIDS programmes, doctors and patients

Ranbaxy Laboratories Limited India has informed WHO that it is voluntarily withdrawing all its antiretrovirals (product dossiers under assessment and all prequalified products) from WHO prequalification. This action was taken after the company found discrepancies in the documentation relating to proof of the products' bioequivalence with originator medicines (see prequalification link below for press release on this matter).

The seven prequalified medicines that the company is voluntarily withdrawing are:
- Indinavir 400 mg capsule, blister (60, 100)
- Lamivudine 150 mg tablet, blister (60, 100)
- Lamivudine/Stavudine 150 mg/40 mg tablet, Al strip (10), 60 in box
- Lamivudine/Stavudine 150 mg/30 mg tablet, Al strip (10), 60 in box
- Nevirapine 200 mg tablet, blister (60, 100)
- Stavudine 30 mg capsule, Al strip (10), 60 in box
- Zidovudine 300 mg tablet, blister (60, 100)