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Prequalified Active Pharmaceutical
Ingredients
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-010 Abacavir (sulfate) Standard HIV/AIDS
Mylan Laboratories
Ltd
27-May-14 27-Sep-18
WHOAPI-193 Abacavir (sulfate) Standard HIV/AIDS Laurus Labs Limited 1-Apr-14 21-Mar-23
WHOAPI-377 Abacavir (sulfate) Standard HIV/AIDS
Jiangsu Weiqida
Pharmaceutical Co
Ltd
9-Dec-22 9-Dec-22
WHOAPI-030
Amodiaquine
(hydrochloride)
Standard Malaria Ipca Laboratories Ltd 3-Sep-13 4-Mar-22
WHOAPI-134
Amodiaquine
(hydrochloride)
Standard Malaria
Mangalam Drugs &
Organics Ltd
7-Dec-11 4-Oct-21
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-080 Artemether Malaria
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 2-Oct-13
WHOAPI-120a Artemether Malaria
Calyx Chemicals &
Pharmaceuticals Ltd
Standard Prequalified 26-Mar-12
WHOAPI-125 Artemether Malaria
KPC Pharmaceuticals
Inc
Standard Prequalified 3-Jun-13
WHOAPI-138 Artemether Malaria
Mangalam Drugs &
Organics Ltd
Standard Prequalified 20-Jun-11
WHOAPI-153 Artemether Malaria
Mylan Laboratories
Ltd
Standard Prequalified 13-Feb-13
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-163 Artemether Malaria Ipca Laboratories Ltd Standard Prequalified 21-Jun-12
WHOAPI-181 Artemether Malaria
Guilin Pharmaceutical
Co Ltd
Standard Prequalified 27-May-14
WHOAPI-235 Artemether Malaria Huvepharma Italia S.r.l Standard Prequalified 6-Oct-15
WHOAPI-081 Artesunate Malaria Ipca Laboratories Ltd Standard Prequalified 4-Apr-12
WHOAPI-084 Artesunate Malaria Huvepharma Italia S.r.l Standard Prequalified 13-Nov-12
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-097a Artesunate Malaria
Solara Active Pharma
Sciences Ltd
Standard Prequalified 29-Aug-11
WHOAPI-097b Artesunate Malaria
Solara Active Pharma
Sciences Ltd
Micronised Prequalified 29-Aug-11
WHOAPI-135 Artesunate Malaria
Mangalam Drugs &
Organics Ltd
Standard Prequalified 29-Aug-11
WHOAPI-355 Artesunate Malaria
Guilin Pharmaceutical
Co Ltd
Standard Prequalified 30-Apr-19
WHOAPI-240
Artesunate
(sterile)
Malaria Ipca Laboratories Ltd Sterile Prequalified 29-Jan-19
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-289
Atazanavir
(sulfate)
HIV/AIDS
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 29-May-19
WHOAPI-303
Atazanavir
(sulfate)
HIV/AIDS
Macleods
Pharmaceuticals Ltd
Standard Prequalified 28-Nov-17
WHOAPI-389
Atazanavir
(sulfate)
HIV/AIDS
Sun Pharmaceutical
Industries Limited
Standard Prequalified 12-Nov-21
WHOAPI-187
Capreomycin
(sulfate, sterile)
Tuberculosis
North China
Pharmaceutical
Huasheng Co Ltd
Sterile Prequalified 27-Oct-14
WHOAPI-423 Carbetocin
Reproductive
health
Piramal Pharma
Limited
Standard Prequalified 7-Oct-22
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-010 Abacavir (sulfate) Standard HIV/AIDS
Mylan Laboratories
Ltd
27-May-14 27-Sep-18
WHOAPI-193 Abacavir (sulfate) Standard HIV/AIDS Laurus Labs Limited 1-Apr-14 21-Mar-23
WHOAPI-377 Abacavir (sulfate) Standard HIV/AIDS
Jiangsu Weiqida
Pharmaceutical Co
Ltd
9-Dec-22 9-Dec-22
WHOAPI-030
Amodiaquine
(hydrochloride)
Standard Malaria Ipca Laboratories Ltd 3-Sep-13 4-Mar-22
WHOAPI-134
Amodiaquine
(hydrochloride)
Standard Malaria
Mangalam Drugs &
Organics Ltd
7-Dec-11 4-Oct-21
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-324 Clofazimine Tuberculosis
Pen Tsao Chemical
Industry Ltd
Standard Prequalified 29-Sep-21
WHOAPI-331 Clofazimine Tuberculosis Dong-A ST Co Ltd Standard Prequalified 24-Sep-21
WHOAPI-118 Cycloserine Tuberculosis Dong-A ST Co Ltd Standard Prequalified 8-Jun-16
WHOAPI-177 Cycloserine Tuberculosis
Solara Active Pharma
Sciences Limited
Standard Prequalified 7-May-13
WHOAPI-327
Daclatasvir
(dihydrochloride)
Hepatitis B
and C
Mylan Laboratories
Ltd
Standard Prequalified 30-Oct-18
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-335
Daclatasvir
(dihydrochloride)
Hepatitis B
and C
Laurus Labs Limited Standard Prequalified 11-Jun-19
WHOAPI-357 Darunavir HIV/AIDS Laurus Labs Limited Standard Prequalified 29-Apr-20
WHOAPI-214
Darunavir
(ethanolate)
HIV/AIDS
Mylan Laboratories
Ltd
Standard Prequalified 25-Apr-17
WHOAPI-350
Darunavir
(ethanolate)
HIV/AIDS
Zhejiang Jiangbei
Pharmaceutical Co Ltd
Standard Prequalified 19-Jun-19
WHOAPI-378
Darunavir
(ethanolate)
HIV/AIDS
Porton Pharma
Solutions Ltd
Standard Prequalified 25-Nov-21
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-411 Dexametasone Covid-19
Tianjin Tianyao
Pharmaceuticals Co.,
Ltd
Standard Prequalified 27-Jan-21
WHOAPI-412
Dexamethasone
(sodium
phosphate)
Covid-19
Tianjin Tianyao
Pharmaceuticals Co.,
Ltd
Standard Prequalified 27-Jan-21
WHOAPI-151
Dihydroartemisin
in
Malaria
Mangalam Drugs &
Organics Ltd
Standard Prequalified 5-Sep-12
WHOAPI-233
Dihydroartemisin
in
Malaria Ipca Laboratories Ltd Standard Prequalified 31-Oct-16
WHOAPI-239a
Dihydroartemisin
in
Malaria
Chongqing Holley
Wuling Mountain
Pharmaceuticals
Standard Prequalified 16-Nov-15
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-239b
Dihydroartemisin
in
Malaria
Chongqing Holley
Wuling Mountain
Pharmaceuticals
Micronised Prequalified 16-Nov-15
WHOAPI-302
Dolutegravir
(sodium)
HIV/AIDS
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 24-Sep-18
WHOAPI-325
Dolutegravir
(sodium)
HIV/AIDS Laurus Labs Limited Standard Prequalified 1-Feb-19
WHOAPI-329
Dolutegravir
(sodium)
HIV/AIDS Micro Labs Limited Micronised Prequalified 14-Jan-19
WHOAPI-354
Dolutegravir
(sodium)
HIV/AIDS
Sun Pharmaceutical
Industries Limited
Standard Prequalified 11-Jun-19
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-362
Dolutegravir
(sodium)
HIV/AIDS
Mylan Laboratories
Ltd
Standard Prequalified 19-Nov-19
WHOAPI-386a
Dolutegravir
(sodium)
HIV/AIDS
Mangalam Drugs &
Organics Ltd
Standard Prequalified 28-Oct-20
WHOAPI-386b
Dolutegravir
(sodium)
HIV/AIDS
Mangalam Drugs &
Organics Ltd
Micronised Prequalified 28-Oct-20
WHOAPI-387
Dolutegravir
(sodium)
HIV/AIDS Laurus Labs Limited Standard Prequalified 30-Jun-20
WHOAPI-071 Efavirenz HIV/AIDS
Mylan Laboratories
Ltd
Standard Prequalified 12-Mar-15
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-090 Efavirenz HIV/AIDS Laurus Labs Limited Standard Prequalified 23-Sep-15
WHOAPI-108 Efavirenz HIV/AIDS
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 16-Jul-14
WHOAPI-318a Efavirenz HIV/AIDS
Mangalam Drugs &
Organics Ltd
Standard Prequalified 24-Sep-18
WHOAPI-318b Efavirenz HIV/AIDS
Mangalam Drugs &
Organics Ltd
micronized Prequalified 22-Feb-22
WHOAPI-039 Emtricitabine HIV/AIDS
Mylan Laboratories
Ltd
Standard Prequalified 29-Jan-16
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-139 Emtricitabine HIV/AIDS Laurus Labs Limited Standard Prequalified 3-May-12
WHOAPI-202 Emtricitabine HIV/AIDS
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 16-Dec-14
WHOAPI-314 Emtricitabine HIV/AIDS
Mangalam Drugs &
Organics Ltd
Standard Prequalified 6-Nov-17
WHOAPI-093
Ethambutol
hydrochloride
Tuberculosis Lupin Ltd Standard Prequalified 10-Oct-12
WHOAPI-197
Ethambutol
hydrochloride
Tuberculosis Lupin Ltd Standard Prequalified 29-Jun-18
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-273
Ethambutol
hydrochloride
Tuberculosis Micro Labs Limited Standard Prequalified 25-May-16
WHOAPI-171 Ethinylestradiol
Reproductive
health
Qinhuangdao Zizhu
Pharmaceutical Co Ltd
Standard Prequalified 4-Jun-13
WHOAPI-105 Ethionamide Tuberculosis
Pen Tsao Chemical
Industry Ltd
Standard Prequalified 23-Apr-13
WHOAPI-422 Ethionamide Tuberculosis Micro Labs Limited Standard Prequalified 6-Apr-23
WHOAPI-406 Flucytosine HIV/AIDS
Solara Active Pharma
Sciences Limited
Standard Prequalified 19-Jan-23
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-005a Isoniazid Tuberculosis Amsal Chem Pvt Ltd Standard Prequalified 5-Sep-17
WHOAPI-005b Isoniazid Tuberculosis Amsal Chem Pvt Ltd Standard Prequalified 5-Sep-17
WHOAPI-086 Isoniazid Tuberculosis
Calyx Chemicals &
Pharmaceuticals Ltd
Standard Prequalified 7-Dec-11
WHOAPI-168 Isoniazid Tuberculosis Second Pharma Co Ltd Standard Prequalified 25-Sep-13
WHOAPI-246
Kanamycin
(sulfate) - non
sterile
Tuberculosis
Livzon Group Fuzhou
Fuxing Pharmaceutical
Co. Ltd
Standard Prequalified 16-Nov-15
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-046 Lamivudine HIV/AIDS
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 18-Dec-12
WHOAPI-069 Lamivudine HIV/AIDS
Mylan Laboratories
Ltd
Standard Prequalified 21-Oct-13
WHOAPI-112 Lamivudine HIV/AIDS
Shijiazhuang Lonzeal
Pharmaceuticals Co
Ltd
Standard Prequalified 3-Sep-13
WHOAPI-265 Lamivudine HIV/AIDS
Anhui Biochem Bio-
Pharmaceutical Co Ltd
Standard Prequalified 20-Sep-17
WHOAPI-346a Lamivudine HIV/AIDS Laurus Labs Limited Standard Prequalified 14-Jan-19
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-346b Lamivudine HIV/AIDS Laurus Labs Limited Micronised Prequalified 14-Jan-19
WHOAPI-203 Levofloxacin Tuberculosis
Zhejiang Langhua
Pharmaceutical Co Ltd
Standard Prequalified 17-Jul-14
WHOAPI-245 Levofloxacin Tuberculosis
Shangyu Jingxin
Pharmaceutical Co Ltd
Standard Prequalified 12-Sep-16
WHOAPI-266 Levofloxacin Tuberculosis Chemo Iberica S.A. Standard Prequalified 18-Feb-19
WHOAPI-172 Levonorgestrel
Reproductive
health
Qinhuangdao Zizhu
Pharmaceutical Co Ltd
Standard Prequalified 30-Aug-13
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-286 Linezolid Tuberculosis Optimus Drugs Pvt Ltd Standard Prequalified 15-Dec-17
WHOAPI-332 Linezolid Tuberculosis Symed Labs Ltd Standard Prequalified 27-Jun-19
WHOAPI-050 Lopinavir HIV/AIDS
Mylan Laboratories
Ltd
Standard Prequalified 12-Mar-15
WHOAPI-363 Lopinavir HIV/AIDS
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 11-Jun-19
WHOAPI-393 Lopinavir HIV/AIDS Laurus Labs Limited Standard Prequalified 28-Aug-20
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-035 Lumefantrine Malaria
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 28-Jan-14
WHOAPI-042 Lumefantrine Malaria Ipca Laboratories Ltd Standard Prequalified 4-Apr-12
WHOAPI-100 Lumefantrine Malaria
Mangalam Drugs &
Organics Ltd
Standard Prequalified 12-Apr-11
WHOAPI-121 Lumefantrine Malaria
Calyx Chemicals &
Pharmaceuticals Ltd
Standard Prequalified 26-Mar-12
WHOAPI-137 Lumefantrine Malaria
Solara Active Pharma
Sciences Ltd
Standard Prequalified 5-Mar-12
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-155 Lumefantrine Malaria
Mylan Laboratories
Ltd
Standard Prequalified 5-Sep-12
WHOAPI-220 Mebendazole
Neglected
tropical
diseases
Changzhou Yabang-QH
Pharmachem Co Ltd
Standard Prequalified 12-Apr-16
WHOAPI-210
Medroxyprogest
erone acetate
Reproductive
health
Farmabios S.p.A Sterile-Micronized Prequalified 22-Oct-14
WHOAPI-271
Medroxyprogest
erone acetate
Reproductive
health
Jiangsu Grand Xianle
Pharmaceutical Co Ltd
Standard Prequalified 9-May-17
WHOAPI-170a Mifepristone
Reproductive
health
Qinhuangdao Zizhu
Pharmaceutical Co Ltd
Standard Prequalified 11-Feb-14
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-170b Mifepristone
Reproductive
health
Qinhuangdao Zizhu
Pharmaceutical Co Ltd
Micronised Prequalified 11-Feb-14
WHOAPI-226
Misoprostol
Dispersion
(1:100 in HPMC)
Reproductive
health
Piramal Healthcare UK
Ltd
Standard Prequalified 17-Dec-15
WHOAPI-439 Molnupiravir Covid-19
Emcure
Pharmaceuticals Ltd
Standard Prequalified 21-Oct-22
WHOAPI-451 Molnupiravir Covid-19
Divi’s Laboratories
Limited
Standard Prequalified 29-Sep-22
WHOAPI-457 Molnupiravir Covid-19 Aurobindo Pharma Ltd Standard Prequalified 4-Jul-23
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-047 Nevirapine HIV/AIDS
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 28-Jan-14
WHOAPI-458 Nirmatrelvir Covid-19
Zhejiang Jiuzhou
Pharmaceutical Co, Ltd
Standard Prequalified 19-May-23
WHOAPI-211
Oseltamivir
(phosphate)
Influenza
Mylan Laboratories
Ltd
Standard Prequalified 29-Apr-14
WHOAPI-379
Oseltamivir
(phosphate)
Influenza Laurus Labs Limited Standard Prequalified 23-Jun-20
WHOAPI-421
Oseltamivir
(phosphate)
Influenza
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 31-Mar-23
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-361 Oxytocin
Reproductive
health
Piramal Pharma
Limited
Standard Prequalified 25-Sep-19
WHOAPI-307
Para-
aminosalicylate
(sodium)
Tuberculosis
Liaoyuan Silver Eagle
Pharmaceutical Co Ltd
Standard Prequalified 21-Oct-20
WHOAPI-176
Piperaquine
(phosphate)
Malaria
Zhuhai Rundu
Pharmaceutical Co Ltd
Standard Prequalified 15-Oct-14
WHOAPI-227
Piperaquine
(phosphate)
Malaria Ipca Laboratories Ltd Standard Prequalified 7-Mar-18
WHOAPI-149a
Piperaquine
phosphate
Malaria
Mangalam Drugs &
Organics Ltd
Standard Prequalified 5-Sep-12
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-149b
Piperaquine
phosphate
Malaria
Mangalam Drugs &
Organics Ltd
Micronised Prequalified 5-Sep-12
WHOAPI-248
Piperaquine
phosphate
Malaria
Chongqing Kangle
Pharmaceutical Co Ltd
Standard Prequalified 9-Nov-17
WHOAPI-243 Praziquantel
Neglected
tropical
diseases
Solara Active Pharma
Sciences Limited
Standard Prequalified 12-Dec-18
WHOAPI-261 Praziquantel
Neglected
tropical
diseases
Minsheng Group
Shaoxing
Pharmaceutical Co Ltd
Standard Prequalified 19-Dec-19
WHOAPI-301 Praziquantel
Neglected
tropical
diseases
Hisun Pharmaceutical
(Nantong) Co Ltd
Standard Prequalified 20-Sep-17
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-309 Praziquantel
Neglected
tropical
diseases
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 12-Jul-18
WHOAPI-338a Praziquantel
Neglected
tropical
diseases
Jiangsu Chengxin
Pharmaceutical Co Ltd
Standard Prequalified 24-Oct-18
WHOAPI-338b Praziquantel
Neglected
tropical
diseases
Jiangsu Chengxin
Pharmaceutical Co Ltd
Micronised Prequalified 24-Oct-18
WHOAPI-341 Praziquantel
Neglected
tropical
diseases
Alivira Animal Health
Limited
Standard Prequalified 10-Mar-20
WHOAPI-390 Praziquantel
Neglected
tropical
diseases
Shilpa Pharma
Lifesciences Limited
Standard Prequalified 27-Jul-21
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-106 Protionamide Tuberculosis
Pen Tsao Chemical
Industry Ltd
Standard Prequalified 13-Feb-13
WHOAPI-424 Protionamide Tuberculosis Micro Labs Limited Standard Prequalified 11-Oct-22
WHOAPI-040 Pyrazinamide Tuberculosis Lupin Ltd Standard Prequalified 10-Oct-12
WHOAPI-078 Pyrazinamide Tuberculosis
Calyx Chemicals &
Pharmaceuticals Ltd
Standard Prequalified 1-Dec-11
WHOAPI-158 Pyrazinamide Tuberculosis Anuh Pharma Ltd Standard Prequalified 12-Jul-12
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-278 Pyrimethamine Malaria
Guilin Pharmaceutical
Co Ltd
Standard Prequalified 30-Jun-17
WHOAPI-360 Pyrimethamine Malaria
Mangalam Drugs &
Organics Ltd
Standard Prequalified 16-Dec-19
WHOAPI-364a Pyrimethamine Malaria Anuh Pharma Ltd Standard Prequalified 25-Sep-20
WHOAPI-364b Pyrimethamine Malaria Anuh Pharma Ltd Micronised Prequalified 25-Sep-20
WHOAPI-405a
Pyronaridine
(phosphate)
Malaria
Mangalam Drugs &
Organics Ltd
Standard Prequalified 15-Jul-22
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-405b
Pyronaridine
(phosphate)
Malaria
Mangalam Drugs &
Organics Ltd
Micronised Prequalified 15-Jul-22
WHOAPI-028 Rifampicin Tuberculosis Lupin Ltd Standard Prequalified 8-May-12
WHOAPI-083 Rifampicin Tuberculosis
Shenyang Antibiotic
Manufacturer
Standard Prequalified 15-Jul-16
WHOAPI-113a Rifampicin Tuberculosis Olon S.p.A. Non-compacted Prequalified 22-Aug-13
WHOAPI-113b Rifampicin Tuberculosis Olon S.p.A. Compacted Prequalified 22-Aug-13
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-113c Rifampicin Tuberculosis Olon S.p.A. Micronised Prequalified 22-Aug-13
WHOAPI-113d Rifampicin Tuberculosis Olon S.p.A. Milled Prequalified 22-Aug-13
WHOAPI-375 Rifapentine Tuberculosis
Macleods
Pharmaceuticals Ltd
Standard Prequalified 1-Dec-21
WHOAPI-065 Ritonavir HIV/AIDS
Mylan Laboratories
Ltd
Standard Prequalified 26-Nov-13
WHOAPI-191 Ritonavir HIV/AIDS
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 25-Nov-14
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-398 Ritonavir HIV/AIDS Laurus Labs Limited Standard Prequalified 7-Dec-21
WHOAPI-290 Sofosbuvir
Hepatitis B
and C
Mylan Laboratories
Ltd
Standard Prequalified 31-Mar-17
WHOAPI-311 Sofosbuvir
Hepatitis B
and C
Solara Active Pharma
Sciences Limited
Standard Prequalified 17-Jun-20
WHOAPI-319 Sofosbuvir
Hepatitis B
and C
Laurus Labs Limited Standard Prequalified 18-Dec-18
WHOAPI-242
Streptomycin
(sulfate, sterile)
Tuberculosis
North China
Pharmaceutical
Huasheng Co Ltd
Sterile Prequalified 14-Jun-16
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-234 Sulfadoxine Malaria Anuh Pharma Ltd Standard Prequalified 17-Dec-15
WHOAPI-279 Sulfadoxine Malaria
Guilin Pharmaceutical
Co Ltd
Standard Prequalified 30-Jun-17
WHOAPI-356 Sulfadoxine Malaria
Mangalam Drugs &
Organics Ltd
Standard Prequalified 12-Dec-18
WHOAPI-038
Tenofovir
disoproxil
fumarate
HIV/AIDS
Mylan Laboratories
Ltd
Standard Prequalified 12-Mar-15
WHOAPI-058
Tenofovir
disoproxil
fumarate
HIV/AIDS
Sun Pharmaceutical
Industries Limited
Standard Prequalified 23-Aug-18
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-195a
Tenofovir
disoproxil
fumarate
HIV/AIDS Laurus Labs Limited Standard Prequalified 11-Apr-14
WHOAPI-195b
Tenofovir
disoproxil
fumarate
HIV/AIDS Laurus Labs Limited Compacted Prequalified 29-Mar-23
WHOAPI-204
Tenofovir
disoproxil
fumarate
HIV/AIDS
Mangalam Drugs &
Organics Ltd
Standard Prequalified 30-Jan-15
WHOAPI-208a
Tenofovir
disoproxil
fumarate
HIV/AIDS
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 2-Jul-15
WHOAPI-208b
Tenofovir
disoproxil
fumarate
HIV/AIDS
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 2-Jul-15
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-236
Tenofovir
disoproxil
fumarate
HIV/AIDS
Solara Active Pharma
Sciences Limited
Standard Prequalified 11-Jan-18
WHOAPI-287
Tenofovir
disoproxil
fumarate
HIV/AIDS
Shijiazhuang Lonzeal
Pharmaceuticals Co
Ltd
Standard Prequalified 27-Jul-18
WHOAPI-317
Tenofovir
disoproxil
fumarate
HIV/AIDS Lupin Ltd Standard Prequalified 12-Dec-18
WHOAPI-391
Tenofovir
disoproxil
fumarate
HIV/AIDS
Shilpa Pharma
Lifesciences Limited
Standard Prequalified 7-Jul-21
WHOAPI-353 Velpatasvir
Hepatitis B
and C
Mylan Laboratories
Ltd
Standard Prequalified 18-Dec-20
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-049a Zidovudine HIV/AIDS
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 2-Apr-13
WHOAPI-049b Zidovudine HIV/AIDS
Shanghai Desano
Chemical
Pharmaceutical Co Ltd
Standard Prequalified 24-May-23
WHOAPI-072 Zidovudine HIV/AIDS
Mylan Laboratories
Ltd
Standard Prequalified 30-Jan-14
WHOAPI-167 Zidovudine HIV/AIDS
Zhejiang Langhua
Pharmaceutical Co Ltd
Standard Prequalified 10-Dec-12
WHOAPI-175 Zidovudine HIV/AIDS
Solara Active Pharma
Sciences Ltd
Standard Prequalified 6-Mar-13
27-03-2023
WHO
Product ID
INN Grade Therapeautic Area Applicant
Date of
Prequalification
Confirmation of
Prequalification
Document Date
WHOAPI-264 Zidovudine HIV/AIDS
Anhui Biochem Bio-
Pharmaceutical Co Ltd
Standard Prequalified 9-May-17
WHOAPI-267 Zidovudine HIV/AIDS
Shanghai Shyndec
Pharmaceutical
(Haimen) Co Ltd
Standard Prequalified 21-Aug-18
WHOAPI-146 Zinc (sulfate) Diarrhoea
Canton Laboratories
Pvt Ltd
Standard Prequalified 7-Dec-16
WHOAPI-232 Zinc (sulfate) Diarrhoea
Dr Paul Lohmann
GmbH & Co KGaA
Standard Prequalified 3-Jul-14
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Prequalified Active Pharmaceutical Ingredients.pptx

  • 1. Website: phongsachgmp.vn Prequalified Active Pharmaceutical Ingredients
  • 2. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-010 Abacavir (sulfate) Standard HIV/AIDS Mylan Laboratories Ltd 27-May-14 27-Sep-18 WHOAPI-193 Abacavir (sulfate) Standard HIV/AIDS Laurus Labs Limited 1-Apr-14 21-Mar-23 WHOAPI-377 Abacavir (sulfate) Standard HIV/AIDS Jiangsu Weiqida Pharmaceutical Co Ltd 9-Dec-22 9-Dec-22 WHOAPI-030 Amodiaquine (hydrochloride) Standard Malaria Ipca Laboratories Ltd 3-Sep-13 4-Mar-22 WHOAPI-134 Amodiaquine (hydrochloride) Standard Malaria Mangalam Drugs & Organics Ltd 7-Dec-11 4-Oct-21
  • 3. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-080 Artemether Malaria Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 2-Oct-13 WHOAPI-120a Artemether Malaria Calyx Chemicals & Pharmaceuticals Ltd Standard Prequalified 26-Mar-12 WHOAPI-125 Artemether Malaria KPC Pharmaceuticals Inc Standard Prequalified 3-Jun-13 WHOAPI-138 Artemether Malaria Mangalam Drugs & Organics Ltd Standard Prequalified 20-Jun-11 WHOAPI-153 Artemether Malaria Mylan Laboratories Ltd Standard Prequalified 13-Feb-13
  • 4. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-163 Artemether Malaria Ipca Laboratories Ltd Standard Prequalified 21-Jun-12 WHOAPI-181 Artemether Malaria Guilin Pharmaceutical Co Ltd Standard Prequalified 27-May-14 WHOAPI-235 Artemether Malaria Huvepharma Italia S.r.l Standard Prequalified 6-Oct-15 WHOAPI-081 Artesunate Malaria Ipca Laboratories Ltd Standard Prequalified 4-Apr-12 WHOAPI-084 Artesunate Malaria Huvepharma Italia S.r.l Standard Prequalified 13-Nov-12
  • 5. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-097a Artesunate Malaria Solara Active Pharma Sciences Ltd Standard Prequalified 29-Aug-11 WHOAPI-097b Artesunate Malaria Solara Active Pharma Sciences Ltd Micronised Prequalified 29-Aug-11 WHOAPI-135 Artesunate Malaria Mangalam Drugs & Organics Ltd Standard Prequalified 29-Aug-11 WHOAPI-355 Artesunate Malaria Guilin Pharmaceutical Co Ltd Standard Prequalified 30-Apr-19 WHOAPI-240 Artesunate (sterile) Malaria Ipca Laboratories Ltd Sterile Prequalified 29-Jan-19
  • 6. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-289 Atazanavir (sulfate) HIV/AIDS Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 29-May-19 WHOAPI-303 Atazanavir (sulfate) HIV/AIDS Macleods Pharmaceuticals Ltd Standard Prequalified 28-Nov-17 WHOAPI-389 Atazanavir (sulfate) HIV/AIDS Sun Pharmaceutical Industries Limited Standard Prequalified 12-Nov-21 WHOAPI-187 Capreomycin (sulfate, sterile) Tuberculosis North China Pharmaceutical Huasheng Co Ltd Sterile Prequalified 27-Oct-14 WHOAPI-423 Carbetocin Reproductive health Piramal Pharma Limited Standard Prequalified 7-Oct-22
  • 7. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-010 Abacavir (sulfate) Standard HIV/AIDS Mylan Laboratories Ltd 27-May-14 27-Sep-18 WHOAPI-193 Abacavir (sulfate) Standard HIV/AIDS Laurus Labs Limited 1-Apr-14 21-Mar-23 WHOAPI-377 Abacavir (sulfate) Standard HIV/AIDS Jiangsu Weiqida Pharmaceutical Co Ltd 9-Dec-22 9-Dec-22 WHOAPI-030 Amodiaquine (hydrochloride) Standard Malaria Ipca Laboratories Ltd 3-Sep-13 4-Mar-22 WHOAPI-134 Amodiaquine (hydrochloride) Standard Malaria Mangalam Drugs & Organics Ltd 7-Dec-11 4-Oct-21
  • 8. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-324 Clofazimine Tuberculosis Pen Tsao Chemical Industry Ltd Standard Prequalified 29-Sep-21 WHOAPI-331 Clofazimine Tuberculosis Dong-A ST Co Ltd Standard Prequalified 24-Sep-21 WHOAPI-118 Cycloserine Tuberculosis Dong-A ST Co Ltd Standard Prequalified 8-Jun-16 WHOAPI-177 Cycloserine Tuberculosis Solara Active Pharma Sciences Limited Standard Prequalified 7-May-13 WHOAPI-327 Daclatasvir (dihydrochloride) Hepatitis B and C Mylan Laboratories Ltd Standard Prequalified 30-Oct-18
  • 9. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-335 Daclatasvir (dihydrochloride) Hepatitis B and C Laurus Labs Limited Standard Prequalified 11-Jun-19 WHOAPI-357 Darunavir HIV/AIDS Laurus Labs Limited Standard Prequalified 29-Apr-20 WHOAPI-214 Darunavir (ethanolate) HIV/AIDS Mylan Laboratories Ltd Standard Prequalified 25-Apr-17 WHOAPI-350 Darunavir (ethanolate) HIV/AIDS Zhejiang Jiangbei Pharmaceutical Co Ltd Standard Prequalified 19-Jun-19 WHOAPI-378 Darunavir (ethanolate) HIV/AIDS Porton Pharma Solutions Ltd Standard Prequalified 25-Nov-21
  • 10. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-411 Dexametasone Covid-19 Tianjin Tianyao Pharmaceuticals Co., Ltd Standard Prequalified 27-Jan-21 WHOAPI-412 Dexamethasone (sodium phosphate) Covid-19 Tianjin Tianyao Pharmaceuticals Co., Ltd Standard Prequalified 27-Jan-21 WHOAPI-151 Dihydroartemisin in Malaria Mangalam Drugs & Organics Ltd Standard Prequalified 5-Sep-12 WHOAPI-233 Dihydroartemisin in Malaria Ipca Laboratories Ltd Standard Prequalified 31-Oct-16 WHOAPI-239a Dihydroartemisin in Malaria Chongqing Holley Wuling Mountain Pharmaceuticals Standard Prequalified 16-Nov-15
  • 11. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-239b Dihydroartemisin in Malaria Chongqing Holley Wuling Mountain Pharmaceuticals Micronised Prequalified 16-Nov-15 WHOAPI-302 Dolutegravir (sodium) HIV/AIDS Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 24-Sep-18 WHOAPI-325 Dolutegravir (sodium) HIV/AIDS Laurus Labs Limited Standard Prequalified 1-Feb-19 WHOAPI-329 Dolutegravir (sodium) HIV/AIDS Micro Labs Limited Micronised Prequalified 14-Jan-19 WHOAPI-354 Dolutegravir (sodium) HIV/AIDS Sun Pharmaceutical Industries Limited Standard Prequalified 11-Jun-19
  • 12. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-362 Dolutegravir (sodium) HIV/AIDS Mylan Laboratories Ltd Standard Prequalified 19-Nov-19 WHOAPI-386a Dolutegravir (sodium) HIV/AIDS Mangalam Drugs & Organics Ltd Standard Prequalified 28-Oct-20 WHOAPI-386b Dolutegravir (sodium) HIV/AIDS Mangalam Drugs & Organics Ltd Micronised Prequalified 28-Oct-20 WHOAPI-387 Dolutegravir (sodium) HIV/AIDS Laurus Labs Limited Standard Prequalified 30-Jun-20 WHOAPI-071 Efavirenz HIV/AIDS Mylan Laboratories Ltd Standard Prequalified 12-Mar-15
  • 13. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-090 Efavirenz HIV/AIDS Laurus Labs Limited Standard Prequalified 23-Sep-15 WHOAPI-108 Efavirenz HIV/AIDS Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 16-Jul-14 WHOAPI-318a Efavirenz HIV/AIDS Mangalam Drugs & Organics Ltd Standard Prequalified 24-Sep-18 WHOAPI-318b Efavirenz HIV/AIDS Mangalam Drugs & Organics Ltd micronized Prequalified 22-Feb-22 WHOAPI-039 Emtricitabine HIV/AIDS Mylan Laboratories Ltd Standard Prequalified 29-Jan-16
  • 14. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-139 Emtricitabine HIV/AIDS Laurus Labs Limited Standard Prequalified 3-May-12 WHOAPI-202 Emtricitabine HIV/AIDS Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 16-Dec-14 WHOAPI-314 Emtricitabine HIV/AIDS Mangalam Drugs & Organics Ltd Standard Prequalified 6-Nov-17 WHOAPI-093 Ethambutol hydrochloride Tuberculosis Lupin Ltd Standard Prequalified 10-Oct-12 WHOAPI-197 Ethambutol hydrochloride Tuberculosis Lupin Ltd Standard Prequalified 29-Jun-18
  • 15. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-273 Ethambutol hydrochloride Tuberculosis Micro Labs Limited Standard Prequalified 25-May-16 WHOAPI-171 Ethinylestradiol Reproductive health Qinhuangdao Zizhu Pharmaceutical Co Ltd Standard Prequalified 4-Jun-13 WHOAPI-105 Ethionamide Tuberculosis Pen Tsao Chemical Industry Ltd Standard Prequalified 23-Apr-13 WHOAPI-422 Ethionamide Tuberculosis Micro Labs Limited Standard Prequalified 6-Apr-23 WHOAPI-406 Flucytosine HIV/AIDS Solara Active Pharma Sciences Limited Standard Prequalified 19-Jan-23
  • 16. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-005a Isoniazid Tuberculosis Amsal Chem Pvt Ltd Standard Prequalified 5-Sep-17 WHOAPI-005b Isoniazid Tuberculosis Amsal Chem Pvt Ltd Standard Prequalified 5-Sep-17 WHOAPI-086 Isoniazid Tuberculosis Calyx Chemicals & Pharmaceuticals Ltd Standard Prequalified 7-Dec-11 WHOAPI-168 Isoniazid Tuberculosis Second Pharma Co Ltd Standard Prequalified 25-Sep-13 WHOAPI-246 Kanamycin (sulfate) - non sterile Tuberculosis Livzon Group Fuzhou Fuxing Pharmaceutical Co. Ltd Standard Prequalified 16-Nov-15
  • 17. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-046 Lamivudine HIV/AIDS Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 18-Dec-12 WHOAPI-069 Lamivudine HIV/AIDS Mylan Laboratories Ltd Standard Prequalified 21-Oct-13 WHOAPI-112 Lamivudine HIV/AIDS Shijiazhuang Lonzeal Pharmaceuticals Co Ltd Standard Prequalified 3-Sep-13 WHOAPI-265 Lamivudine HIV/AIDS Anhui Biochem Bio- Pharmaceutical Co Ltd Standard Prequalified 20-Sep-17 WHOAPI-346a Lamivudine HIV/AIDS Laurus Labs Limited Standard Prequalified 14-Jan-19
  • 18. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-346b Lamivudine HIV/AIDS Laurus Labs Limited Micronised Prequalified 14-Jan-19 WHOAPI-203 Levofloxacin Tuberculosis Zhejiang Langhua Pharmaceutical Co Ltd Standard Prequalified 17-Jul-14 WHOAPI-245 Levofloxacin Tuberculosis Shangyu Jingxin Pharmaceutical Co Ltd Standard Prequalified 12-Sep-16 WHOAPI-266 Levofloxacin Tuberculosis Chemo Iberica S.A. Standard Prequalified 18-Feb-19 WHOAPI-172 Levonorgestrel Reproductive health Qinhuangdao Zizhu Pharmaceutical Co Ltd Standard Prequalified 30-Aug-13
  • 19. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-286 Linezolid Tuberculosis Optimus Drugs Pvt Ltd Standard Prequalified 15-Dec-17 WHOAPI-332 Linezolid Tuberculosis Symed Labs Ltd Standard Prequalified 27-Jun-19 WHOAPI-050 Lopinavir HIV/AIDS Mylan Laboratories Ltd Standard Prequalified 12-Mar-15 WHOAPI-363 Lopinavir HIV/AIDS Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 11-Jun-19 WHOAPI-393 Lopinavir HIV/AIDS Laurus Labs Limited Standard Prequalified 28-Aug-20
  • 20. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-035 Lumefantrine Malaria Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 28-Jan-14 WHOAPI-042 Lumefantrine Malaria Ipca Laboratories Ltd Standard Prequalified 4-Apr-12 WHOAPI-100 Lumefantrine Malaria Mangalam Drugs & Organics Ltd Standard Prequalified 12-Apr-11 WHOAPI-121 Lumefantrine Malaria Calyx Chemicals & Pharmaceuticals Ltd Standard Prequalified 26-Mar-12 WHOAPI-137 Lumefantrine Malaria Solara Active Pharma Sciences Ltd Standard Prequalified 5-Mar-12
  • 21. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-155 Lumefantrine Malaria Mylan Laboratories Ltd Standard Prequalified 5-Sep-12 WHOAPI-220 Mebendazole Neglected tropical diseases Changzhou Yabang-QH Pharmachem Co Ltd Standard Prequalified 12-Apr-16 WHOAPI-210 Medroxyprogest erone acetate Reproductive health Farmabios S.p.A Sterile-Micronized Prequalified 22-Oct-14 WHOAPI-271 Medroxyprogest erone acetate Reproductive health Jiangsu Grand Xianle Pharmaceutical Co Ltd Standard Prequalified 9-May-17 WHOAPI-170a Mifepristone Reproductive health Qinhuangdao Zizhu Pharmaceutical Co Ltd Standard Prequalified 11-Feb-14
  • 22. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-170b Mifepristone Reproductive health Qinhuangdao Zizhu Pharmaceutical Co Ltd Micronised Prequalified 11-Feb-14 WHOAPI-226 Misoprostol Dispersion (1:100 in HPMC) Reproductive health Piramal Healthcare UK Ltd Standard Prequalified 17-Dec-15 WHOAPI-439 Molnupiravir Covid-19 Emcure Pharmaceuticals Ltd Standard Prequalified 21-Oct-22 WHOAPI-451 Molnupiravir Covid-19 Divi’s Laboratories Limited Standard Prequalified 29-Sep-22 WHOAPI-457 Molnupiravir Covid-19 Aurobindo Pharma Ltd Standard Prequalified 4-Jul-23
  • 23. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-047 Nevirapine HIV/AIDS Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 28-Jan-14 WHOAPI-458 Nirmatrelvir Covid-19 Zhejiang Jiuzhou Pharmaceutical Co, Ltd Standard Prequalified 19-May-23 WHOAPI-211 Oseltamivir (phosphate) Influenza Mylan Laboratories Ltd Standard Prequalified 29-Apr-14 WHOAPI-379 Oseltamivir (phosphate) Influenza Laurus Labs Limited Standard Prequalified 23-Jun-20 WHOAPI-421 Oseltamivir (phosphate) Influenza Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 31-Mar-23
  • 24. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-361 Oxytocin Reproductive health Piramal Pharma Limited Standard Prequalified 25-Sep-19 WHOAPI-307 Para- aminosalicylate (sodium) Tuberculosis Liaoyuan Silver Eagle Pharmaceutical Co Ltd Standard Prequalified 21-Oct-20 WHOAPI-176 Piperaquine (phosphate) Malaria Zhuhai Rundu Pharmaceutical Co Ltd Standard Prequalified 15-Oct-14 WHOAPI-227 Piperaquine (phosphate) Malaria Ipca Laboratories Ltd Standard Prequalified 7-Mar-18 WHOAPI-149a Piperaquine phosphate Malaria Mangalam Drugs & Organics Ltd Standard Prequalified 5-Sep-12
  • 25. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-149b Piperaquine phosphate Malaria Mangalam Drugs & Organics Ltd Micronised Prequalified 5-Sep-12 WHOAPI-248 Piperaquine phosphate Malaria Chongqing Kangle Pharmaceutical Co Ltd Standard Prequalified 9-Nov-17 WHOAPI-243 Praziquantel Neglected tropical diseases Solara Active Pharma Sciences Limited Standard Prequalified 12-Dec-18 WHOAPI-261 Praziquantel Neglected tropical diseases Minsheng Group Shaoxing Pharmaceutical Co Ltd Standard Prequalified 19-Dec-19 WHOAPI-301 Praziquantel Neglected tropical diseases Hisun Pharmaceutical (Nantong) Co Ltd Standard Prequalified 20-Sep-17
  • 26. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-309 Praziquantel Neglected tropical diseases Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 12-Jul-18 WHOAPI-338a Praziquantel Neglected tropical diseases Jiangsu Chengxin Pharmaceutical Co Ltd Standard Prequalified 24-Oct-18 WHOAPI-338b Praziquantel Neglected tropical diseases Jiangsu Chengxin Pharmaceutical Co Ltd Micronised Prequalified 24-Oct-18 WHOAPI-341 Praziquantel Neglected tropical diseases Alivira Animal Health Limited Standard Prequalified 10-Mar-20 WHOAPI-390 Praziquantel Neglected tropical diseases Shilpa Pharma Lifesciences Limited Standard Prequalified 27-Jul-21
  • 27. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-106 Protionamide Tuberculosis Pen Tsao Chemical Industry Ltd Standard Prequalified 13-Feb-13 WHOAPI-424 Protionamide Tuberculosis Micro Labs Limited Standard Prequalified 11-Oct-22 WHOAPI-040 Pyrazinamide Tuberculosis Lupin Ltd Standard Prequalified 10-Oct-12 WHOAPI-078 Pyrazinamide Tuberculosis Calyx Chemicals & Pharmaceuticals Ltd Standard Prequalified 1-Dec-11 WHOAPI-158 Pyrazinamide Tuberculosis Anuh Pharma Ltd Standard Prequalified 12-Jul-12
  • 28. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-278 Pyrimethamine Malaria Guilin Pharmaceutical Co Ltd Standard Prequalified 30-Jun-17 WHOAPI-360 Pyrimethamine Malaria Mangalam Drugs & Organics Ltd Standard Prequalified 16-Dec-19 WHOAPI-364a Pyrimethamine Malaria Anuh Pharma Ltd Standard Prequalified 25-Sep-20 WHOAPI-364b Pyrimethamine Malaria Anuh Pharma Ltd Micronised Prequalified 25-Sep-20 WHOAPI-405a Pyronaridine (phosphate) Malaria Mangalam Drugs & Organics Ltd Standard Prequalified 15-Jul-22
  • 29. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-405b Pyronaridine (phosphate) Malaria Mangalam Drugs & Organics Ltd Micronised Prequalified 15-Jul-22 WHOAPI-028 Rifampicin Tuberculosis Lupin Ltd Standard Prequalified 8-May-12 WHOAPI-083 Rifampicin Tuberculosis Shenyang Antibiotic Manufacturer Standard Prequalified 15-Jul-16 WHOAPI-113a Rifampicin Tuberculosis Olon S.p.A. Non-compacted Prequalified 22-Aug-13 WHOAPI-113b Rifampicin Tuberculosis Olon S.p.A. Compacted Prequalified 22-Aug-13
  • 30. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-113c Rifampicin Tuberculosis Olon S.p.A. Micronised Prequalified 22-Aug-13 WHOAPI-113d Rifampicin Tuberculosis Olon S.p.A. Milled Prequalified 22-Aug-13 WHOAPI-375 Rifapentine Tuberculosis Macleods Pharmaceuticals Ltd Standard Prequalified 1-Dec-21 WHOAPI-065 Ritonavir HIV/AIDS Mylan Laboratories Ltd Standard Prequalified 26-Nov-13 WHOAPI-191 Ritonavir HIV/AIDS Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 25-Nov-14
  • 31. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-398 Ritonavir HIV/AIDS Laurus Labs Limited Standard Prequalified 7-Dec-21 WHOAPI-290 Sofosbuvir Hepatitis B and C Mylan Laboratories Ltd Standard Prequalified 31-Mar-17 WHOAPI-311 Sofosbuvir Hepatitis B and C Solara Active Pharma Sciences Limited Standard Prequalified 17-Jun-20 WHOAPI-319 Sofosbuvir Hepatitis B and C Laurus Labs Limited Standard Prequalified 18-Dec-18 WHOAPI-242 Streptomycin (sulfate, sterile) Tuberculosis North China Pharmaceutical Huasheng Co Ltd Sterile Prequalified 14-Jun-16
  • 32. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-234 Sulfadoxine Malaria Anuh Pharma Ltd Standard Prequalified 17-Dec-15 WHOAPI-279 Sulfadoxine Malaria Guilin Pharmaceutical Co Ltd Standard Prequalified 30-Jun-17 WHOAPI-356 Sulfadoxine Malaria Mangalam Drugs & Organics Ltd Standard Prequalified 12-Dec-18 WHOAPI-038 Tenofovir disoproxil fumarate HIV/AIDS Mylan Laboratories Ltd Standard Prequalified 12-Mar-15 WHOAPI-058 Tenofovir disoproxil fumarate HIV/AIDS Sun Pharmaceutical Industries Limited Standard Prequalified 23-Aug-18
  • 33. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-195a Tenofovir disoproxil fumarate HIV/AIDS Laurus Labs Limited Standard Prequalified 11-Apr-14 WHOAPI-195b Tenofovir disoproxil fumarate HIV/AIDS Laurus Labs Limited Compacted Prequalified 29-Mar-23 WHOAPI-204 Tenofovir disoproxil fumarate HIV/AIDS Mangalam Drugs & Organics Ltd Standard Prequalified 30-Jan-15 WHOAPI-208a Tenofovir disoproxil fumarate HIV/AIDS Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 2-Jul-15 WHOAPI-208b Tenofovir disoproxil fumarate HIV/AIDS Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 2-Jul-15
  • 34. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-236 Tenofovir disoproxil fumarate HIV/AIDS Solara Active Pharma Sciences Limited Standard Prequalified 11-Jan-18 WHOAPI-287 Tenofovir disoproxil fumarate HIV/AIDS Shijiazhuang Lonzeal Pharmaceuticals Co Ltd Standard Prequalified 27-Jul-18 WHOAPI-317 Tenofovir disoproxil fumarate HIV/AIDS Lupin Ltd Standard Prequalified 12-Dec-18 WHOAPI-391 Tenofovir disoproxil fumarate HIV/AIDS Shilpa Pharma Lifesciences Limited Standard Prequalified 7-Jul-21 WHOAPI-353 Velpatasvir Hepatitis B and C Mylan Laboratories Ltd Standard Prequalified 18-Dec-20
  • 35. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-049a Zidovudine HIV/AIDS Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 2-Apr-13 WHOAPI-049b Zidovudine HIV/AIDS Shanghai Desano Chemical Pharmaceutical Co Ltd Standard Prequalified 24-May-23 WHOAPI-072 Zidovudine HIV/AIDS Mylan Laboratories Ltd Standard Prequalified 30-Jan-14 WHOAPI-167 Zidovudine HIV/AIDS Zhejiang Langhua Pharmaceutical Co Ltd Standard Prequalified 10-Dec-12 WHOAPI-175 Zidovudine HIV/AIDS Solara Active Pharma Sciences Ltd Standard Prequalified 6-Mar-13
  • 36. 27-03-2023 WHO Product ID INN Grade Therapeautic Area Applicant Date of Prequalification Confirmation of Prequalification Document Date WHOAPI-264 Zidovudine HIV/AIDS Anhui Biochem Bio- Pharmaceutical Co Ltd Standard Prequalified 9-May-17 WHOAPI-267 Zidovudine HIV/AIDS Shanghai Shyndec Pharmaceutical (Haimen) Co Ltd Standard Prequalified 21-Aug-18 WHOAPI-146 Zinc (sulfate) Diarrhoea Canton Laboratories Pvt Ltd Standard Prequalified 7-Dec-16 WHOAPI-232 Zinc (sulfate) Diarrhoea Dr Paul Lohmann GmbH & Co KGaA Standard Prequalified 3-Jul-14