Table 4.
Drug name | Brand name (if applicable) | Strength (mg) | Pack size | Manufacturer | Country of manufacture | Batch number | Manufacturing date | Expiry date | No. of samples | Dissolution test (compliance with tolerance limits) | HPLC (contained stated amount of active ingredient) |
---|---|---|---|---|---|---|---|---|---|---|---|
Artesunate | Not stated | 50 | 36 | Aurochem Pharma | India | AFJ35A /08C01 | 03/2008 | 02/2011 | 2 | Not undertaken | Yes |
Artesunate | Falcigo | 50 | 32 | Zydus Adila Healthcare | India | ZHJ2175 | 06/2009 | 06/2011 | 1 | Not undertaken | Yes |
Sulfadoxine/Pyrimethamine | Fansidar | 500/25 | 3 | Efroze Chemical Industries | Pakistan | H003 | 07/2007 | 06/2010 | 2 | No | Yes |
Sulfadoxine/Pyrimethamine | Fansidar | 500/25 | 14 | Roche Pharm. | Pakistan | 000267 | 01/2009 | 01/2012 | 2 | No | Yes |
Sulfadoxine/Pyrimethamine | Fansidar | 500/25 | 14 | Roche Pharm. | Pakistan | 755 | 10/2005 | 10/2010 | 2 | No | Yes |
Sulfadoxine/Pyrimethamine | Fansidar | 500/25 | 14 | Roche Pharm. | Pakistan | P01075 | 02/2008 | 03/2011 | 2 | No | Yes |
Sulfadoxine/Pyrimethamine | Maladar | 500/25 | 15 | Roche Pharm. | Pakistan | P001103 | 01/2009 | 01/2013 | 1 | No | Yes |
Quinine | Howards | 300 | 99 | Howards | Pakistan | 70321 | 05/2007 | 05/2012 | 1 | No | Yes |
Quinine | Howards | 300 | 99 | Howards | Pakistan | 80576 | 08/2008 | 08/2013 | 1 | No | Yes |
Quinine | Howards | 300 | 99 | Howards | Pakistan | 70322 | 05/2007 | 05/2012 | 1 | No | Yes |
Chloroquine | Not stated | 150 | 30 | Pars Darou | Iran | 7800 | 12/2006 | 11/2010 | 1 | Yes | Yes |
Chloroquine | Not stated | 150 | 30 | Khawarazwy | Iran | n/a | 07/2006 | 07/2010 | 1 | Yes | Yes |
Chloroquine | Not stated | 150 | 30 | Sanofi-Aventis | Pakistan | U060 | 05/2008 | 04/2012 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | N165 | 12/2006 | 11/2010 | 2 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | U067 | 06/2008 | 05/2012 | 2 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | C014 | 01/2009 | 12/2012 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | U007 | 01/2008 | 12/2011 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | N165 | 12/2007 | 11/2011 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | B178 | 09/2007 | 08/2011 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | U067 | 06/2008 | 05/2012 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | U195 | 06/2008 | 05/2012 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | C049 | 02/2009 | 01/2013 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | C098 | 02/2009 | 01/2013 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | C085 | 04/2009 | 03/2013 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | C014 | 12/2008 | 11/2012 | 2 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | HC143 | 07/2009 | 06/2013 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | C127 | 06/2009 | 05/2013 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | B193 | 10/2007 | 09/2011 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 20 | Sanofi-Aventis | Pakistan | U167 | 10/2008 | 09/2012 | 1 | Yes | Yes |
Chloroquine | Nivaquine-P | 250 | 30 | Sanofi-Aventis | Pakistan | U046 | 05/2008 | 04/2012 | 3 | Yes | Yes |
Complaint with USP tolerance limits | – | – | – | – | – | – | – | – | – | 25/37 (68%) | 40/40 |
Noncompliant with USP tolerance limits | 12/37 (32%) | 0 | |||||||||
Total | 37 | 40 |
HPLC = high-performance liquid chromatography; USP = U.S. Pharmacopeia.
Samples of chloroquine, sulfadoxine/pyrimethamine, and quinine were made by the same manufacturer but were from different batches as denoted by the batch number.