This document lists various prequalified active pharmaceutical ingredients from the WHO. It includes the product ID, INN, grade, therapeutic area, applicant, date of prequalification, and confirmation date. There are over 400 entries listed with information about different APIs that have been prequalified for treatments of conditions like HIV/AIDS, malaria, tuberculosis, hepatitis, and others.

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

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