WHO List of Prequalified Medicinal Products

Please enter the criteria below to display products from the WHO list of prequalified medicinal products. (24-Apr-2013)




* WHO reference number or "USFDA"/"HCnda"

Legend:
"+" means combination product, both fixed-dose combination (co-formulated) and co-packaged product (i.e. co-blister)
[A+B] + C means A and B are in a fixed-dose formulation and C is co-packaged
"*" refers to products approved by both WHO Prequalification Programme and US FDA
USFDA1 approved by US FDA; USFDA2 tentatively approved by US FDA; EMEA Art 58 - approved by EMEA according to Article 58
Note: For information about the listing of prequalified products and the alternative approval procedure, please see: General information

Count: 28 | Download as PDF | Download as Excel
Therapeutic area INN Formulation and strength Applicant Manufacturing site Packaging Reference no. Date of PQ Status
MA Amodiaquine Film-coated tablets 150mg Guilin Pharmaceutical Co. Ltd Guilin, Guangxi, China PVC/Alu blisters 6; Cardboard box 2 x 6 MA045 30-Aug-2007
MA Amodiaquine (as hydrochloride) + Artesunate Tablets 67.5mg+25mg Ipca Laboratories Ltd Dadra and Nagar Haveli (U.T.), India Alu/Alu blister 10x1x3, 25x3 MA080 01-Jun-2012
MA Amodiaquine (as hydrochloride) + Artesunate Tablets 67.5mg + 25mg Guilin Pharmaceutical Co., Ltd. Guilin, Guangxi, China Alu/PA/Alu/PVC blister 1 x 3 MA083 16-Nov-2012
MA Amodiaquine (as hydrochloride) + Artesunate Tablets 270mg+100mg Ipca Laboratories Ltd Dadra and Nagar Haveli (U.T.), India Alu/Alu blister 10x1x3, 10x1x6, 25x3, 25x6 MA082 01-Jun-2012
MA Amodiaquine (as hydrochloride) + Artesunate Tablets 270mg + 100mg Guilin Pharmaceutical Co., Ltd. Guilin, Guangxi, China Alu/PA/ALu/PVC blister 1 x 3, 1 x 6 MA085 16-Nov-2012
MA Amodiaquine (as hydrochloride) + Artesunate Tablets 135mg+50mg Ipca Laboratories Ltd Dadra and Nagar Haveli (U.T.), India Alu/Alu blister 10x1x3, 25x3 MA081 01-Jun-2012
MA Amodiaquine (as hydrochloride) + Artesunate Tablets 135mg + 50mg Guilin Pharmaceutical Co., Ltd. Guilin, Guangxi, China Alu/PA/Alu/PVC blister 1 x 3 MA084 16-Nov-2012
MA Amodiaquine (as hydrochloride) + Artesunate Tablets (co-blistered) 153mg + 50mg Strides Arcolab Limited Bangalore, India Alu/PVC/PE/PVDC blister 10 x (12+12), 10 x (6+6), 10 x (3+3) MA074 22-Dec-2011
MA Amodiaquine + Artesunate Tablets 67.5mg + 25mg Sanofi-Aventis Group MAPHAR Laboratories, Casablanca, Morocco Alu/Alu blister 3 x 1, 3 x 25 MA056 14-Oct-2008
MA Amodiaquine + Artesunate Tablets 270mg + 100mg Sanofi-Aventis Group MAPHAR Laboratories, Casablanca, Morocco; Rottendorf Pharma, Ennigerloh, Germany; Batch released by: Sanofi-Aventis Maroc, Casablanca, Morocco Alu/Alu blister 3 x 1, 3 x 25, 6 x 1, 6 x 25 MA058 14-Oct-2008
MA Amodiaquine + Artesunate Tablets 153mg (200mg as hydrochloride) + Tablets 50mg Ipca Laboratories Limited Dadra and Nagar Haveli (U.T.), India PVdC/PVC/Alu blister 12+12, 6+6, 3+3 MA001 23-Apr-2008
MA Amodiaquine + Artesunate Tablets 153mg (200mg as hydrochloride) + Tablets 50mg Cipla Ltd Patalganga, India; Goa, India PVC/PVDC/Alu blister 3 + 3, 6 + 6, 12 + 12 MA047 11-Nov-2008
MA Amodiaquine + Artesunate Tablets 150mg + 50mg Guilin Pharmaceutical Co. Ltd Guilin, Guangxi, China PVC/Alu blister 3x(4+4), 3+3, 6+6, 12+12 MA046 30-Aug-2007
MA Amodiaquine + Artesunate Tablets 135mg + 50mg Sanofi-Aventis Group MAPHAR Laboratories, Casablanca, Morocco Alu/Alu blister 3 x 1, 3 x 25 MA057 14-Oct-2008
MA Artemether + Lumefantrine Tablets 20mg + 120mg Ajanta Pharma Ltd Paithan, Aurangabad, Maharashtra, India PVC/PVdC/Alu blister 2 x 8; 3 x 8; 30 x 6; 30 x 12; 30 x 18; 30 x 24 MA052 16-Dec-2008
MA Artemether + Lumefantrine Tablets 20mg + 120mg Novartis Pharma Beijing, China; Suffern, USA Blister 6, 12, 18, 24 MA026 26-Apr-2004
MA Artemether + Lumefantrine Tablets 20mg + 120mg Ipca Laboratories Ltd Dadra and Nagar Haveli (U.T.), India PVDC/PVC/Alu blister 30 x 6, 30 x 12, 30 x 18, 30 x 24 MA062 15-Dec-2009
MA Artemether + Lumefantrine Tablets 20mg + 120mg Cipla Ltd Patalganga, Himachal Pradesh, Goa, Kurkumbh, Indore, India; Quality Chemical Industries Ltd, Kampala, Uganda PVC-PCTFE/Alu Blister 6,12,18,24; Alu/Alu Blister 6 (1x6), 12 (2x6), 18 (3x6), 24 (4x6) MA064 22-May-2009
MA Artemether + Lumefantrine Dispersible tablets 20mg + 120mg Novartis Pharma AG Novartis Pharmaceuticals Corporation, Suffern, USA PVC/PCTFE/PVC/Alu blister or PVC/PCTFE/Alu blister 30 X 6; 30 X 12; 30 X 18 MA069 27-Feb-2009
MA Artemether + Lumefantrine Dispersible tablets 20mg + 120mg Ajanta Pharma Ltd Paithan, Aurangabad, Maharashtra, India PVC/PVdC/Alu blister 1 x 6, 30 x 6, 1 x 12, 30 x 12 MA092 19-Dec-2012
MA Artemotil Solution injection 50mg/ml Artecef BV Rotexmedica GmbH, Trittau, Germany Glass ampoules 1ml MA027 01-Mar-2006
MA Artemotil Solution injection 150mg/ml Artecef BV Rotexmedica GmbH, Trittau, Germany Glass ampoules 1ml MA028 01-Mar-2006
MA Artesunate Tablets 50mg Ipca Laboratories Ltd Dadra and Nagar Haveli (U.T.), India PVdC/Al blisters 12 MA038 30-Aug-2007
MA Artesunate Tablets 50mg Guilin Pharmaceutical Co. Ltd Guilin, Guangxi, China Blister 12 MA044 21-Dec-2005
MA Artesunate Powder for Injection 60mg Guilin Pharmaceutical Co., Ltd. Guilin, Guangxi, P.R. China Vial [1 vial of artesunate powder is co-packed with 1 ampoule of sodium bicarbonate injection (1ml:50mg) and 1 ampoule of sodium chloride injection (5ml:45mg)] MA051 05-Nov-2010
MA Artesunate + [Sulfadoxine + Pyrimethamine] Tablets + Tablets 50mg + [500mg + 25mg] Guilin Pharmaceutical Co., Ltd. Guilin, Guangxi, China PVC/Alu blister 3 + 1; 6 + 2 MA066 24-May-2012
MA Artesunate + Mefloquine (as hydrochloride) Tablets 25mg + 50mg DNDi, Switzerland (Cipla Ltd is the supplier and is responsible for the product) Cipla Ltd, Patalganga, India Alu/Alu strip 1 x 3, 2 x 3 MA078 12-Sep-2012
MA Artesunate + Mefloquine (as hydrochloride) Tablets 100mg + 200mg DNDi, Switzerland (Cipla Ltd is the supplier and is responsible for the product) Cipla Ltd, Patalganga, India Alu/Alu strip 1 x 3, 2 x 3 MA079 12-Sep-2012