Analysis of generic antiretroviral formulations manufactured in India
Ramachandran, G.; Perloff, E.S.; von Moltke, L.L.; Swaminathan, S.; Wanke, C.A.; Greenblatt, D.J.
Aids 18(10): 1482-1484
2004
ISSN/ISBN: 0269-9370 PMID: 15199331 DOI: 10.1097/01.aids.0000131346.76289.27Document Number: 234541
The contents of six commonly used nucleoside and non-nucleoside reverse transcriptase inhibitors alone and in combination, from three Indian sources (Aurobindo Pharma, Ranbaxy and Cipla) were analysed and the values were compared with proprietary medications manufactured in the USA. The antiretroviral drugs tested were efavirenz (600 mg), nevirapine (200 mg), zidovudine (300 mg), didanosine (250 mg), stavudine (30 mg), lamivudine (150 mg), and a combination pill containing nevirapine, stavudine, and lamivudine in the same dosages. Results showed that the drugs compared well with the proprietary formulations and the variability ranged from 0.01 to 8.3%. All formulations were within the 5% range of the stated contents compared with the proprietary drugs, except for stavudine and lamivudine, which were slightly higher but within the 10% range. The analyses of specific antiretroviral medications supplied by Aurobindo Pharma, Ranbaxy, and Cipla from India indicate that the amount of active drug is very similar to those medications manufactured in the USA.