Medicines/Finished Pharmaceutical Products

E.g., 09/18/2019
E.g., 09/18/2019
Formulation:
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
  • (a) means SRA-approved innovator or SRA-approved generic that has been prequalified based on abbreviated assessment
  • "*" refers to products approved by both WHO and US FDA
  • USFDA1 approved by US FDA
  • USFDA2 tentatively approved by US FDA
  • EMA Art. 58 - approved by EMA according to Article 58

  • Note:
  • For information about the listing of prequalified products and the alternative approval procedure, please see: General Information
  • Click on the WHO REFERENCE NUMBER to see more detailed information

  • Displaying: 1 - 50 of 551
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalificationsort ascending
    HA714 Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Film-coated 400mg/300mg/300mg 30 Aug 2019
    MA087 Artemether Malaria Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Solution for injection 80mg/ml 29 Aug 2019
    HA717 Emtricitabine/Tenofovir disoproxil fumarate HIV/AIDS Laurus Labs Limited, 2nd Floor, Serene Chambers, Road 7, Banjara Hills, Hyderabad, Telangana, 500 034, India Tablet, Film-coated 200mg/300mg 22 Aug 2019
    MA137 Artemether/Lumefantrine Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 20mg/120mg 22 Aug 2019
    MA142 Artemether/Lumefantrine Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 80mg/480mg 22 Aug 2019
    MA143 Artemether/Lumefantrine Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 40mg/240mg 22 Aug 2019
    TB352 Ethionamide Tuberculosis Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Dispersible 125mg 23 Jul 2019
    HA683 Darunavir (ethanolate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 800mg 11 Jun 2019
    HA685 Darunavir (ethanolate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 600mg 11 Jun 2019
    HA698 Abacavir (sulfate)/Lamivudine HIV/AIDS Sun Pharmaceutical Industries Limited, Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India Tablet, Film-coated 600mg/300mg 11 Jun 2019
    HA733 (a) Darunavir HIV/AIDS Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Tablet, Film-coated 600mg 11 Jun 2019
    HA738 (a) Ciprofloxacin (hydrochloride) HIV/AIDS Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd), Mumbai, 400030, India Tablet, Film-coated 500mg 11 Jun 2019
    TB214 Streptomycin (sulfate) - Sterile Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Powder for solution for injection 1000mg 16 May 2019
    HP015 Daclatasvir (dihydrochloride) Hepatitis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 30mg 15 May 2019
    HP016 Daclatasvir (dihydrochloride) Hepatitis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 60mg 15 May 2019
    MA125 Amodiaquine (hydrochloride)/Artesunate Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 67.5mg/25mg 15 May 2019
    MA126 Amodiaquine (hydrochloride)/Artesunate Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 135mg/50mg 15 May 2019
    MA127 Amodiaquine (hydrochloride)/Artesunate Malaria Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet 270mg/100mg 15 May 2019
    TB338 Levofloxacin Tuberculosis MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 250mg 15 May 2019
    TB339 Levofloxacin Tuberculosis MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 500mg 15 May 2019
    TB340 Levofloxacin Tuberculosis MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 750mg 15 May 2019
    HA629 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet, Film-coated 150mg/200mg/300mg 04 May 2019
    HA686 Sulfamethoxazole/Trimethoprim HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 400mg/80mg 05 Apr 2019
    HA687 Sulfamethoxazole/Trimethoprim HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 800mg/160mg 05 Apr 2019
    HA702 Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 50mg/300mg/300mg 05 Apr 2019
    NT006 Mebendazole Neglected Tropical Diseases (NTD) Janssen-Cilag International NV, Turnhoutseweg 30, Beerse, 2340, Belgium Tablets, Chewable 500mg 05 Apr 2019
    TB311 Moxifloxacin (hydrochloride) Tuberculosis Getz Pharma Pvt Ltd, 29-30/27 Korangi Industrial Area, Karachi, 74900 Tablet, Film-coated 400mg 22 Feb 2019
    TB354 Levofloxacin Tuberculosis PT. Kalbe Farma Tbk., Line 8A, Kawasan Industri Delta Silicon, Jl.M.H.Thamrin Blok A3-1, Lippo Cikarang, Bekasi, 17550, Indonesia Tablet, Film-coated 500mg 22 Feb 2019
    HP024 (a) Sofosbuvir/Velpatasvir Hepatitis Gilead Sciences Ireland UC, IDA Business & Technology Park, Carrigtohill, County Cork, Ireland Tablet, Film-coated 400mg/100mg 06 Feb 2019
    MA138 Artemether/Lumefantrine Malaria Strides Pharma Global PTE Limited, 3, Tuas South Avenue 4, 637610, Singapore Tablet 80mg/480mg 06 Feb 2019
    TB327 Kanamycin (sulfate) Tuberculosis Livzon (Group) Pharmaceutical Factory, No. 38 Chuangye Road North, Jinwan District, Zhuhai, Guangdong, 519045 Solution for injection 500mg/2ml 06 Feb 2019
    TB328 Kanamycin (sulfate) Tuberculosis Livzon (Group) Pharmaceutical Factory, No. 38 Chuangye Road North, Jinwan District, Zhuhai, Guangdong, 519045 Solution for injection 1000mg/3ml 06 Feb 2019
    TB351 Linezolid Tuberculosis Celltrion Inc., 23 Academy-ro,, Yeonsu-gu, Incheon, 22014, Republic of Korea Tablet, Film-coated 600mg 06 Feb 2019
    TB343 Kanamycin (sulfate) Tuberculosis Mylan Laboratories Limited, Speciality Formulation Facility, No. 19A, Plot No.284-B/1, Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bangalore, 560105, India Solution for injection 500mg/2ml 24 Jan 2019
    TB344 Kanamycin (sulfate) Tuberculosis Mylan Laboratories Limited, Speciality Formulation Facility, No. 19A, Plot No.284-B/1, Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bangalore, 560105, India Solution for injection 1000mg/3ml 24 Jan 2019
    HA668 Lamivudine HIV/AIDS Beximco Pharmaceuticals Ltd, 19, Dhanmondi R/A, Road No. 7, Dhaka, 1205, Bangladesh Tablet, Film-coated 300mg 21 Jan 2019
    HA656 Lamivudine/Zidovudine HIV/AIDS Anhui Biochem Bio-pharmaceutical Co., Ltd., No. 30 Hongfeng Road, Hi-Tech Development Zone, Hefei City, Anhui Province, 230088, China (People's Republic of) Tablet, Film-coated 150mg/300mg 18 Dec 2018
    HA688 Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil (fumarate) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 50mg/300mg/300mg 18 Dec 2018
    HA716 (a) Ciprofloxacin (hydrochloride) HIV/AIDS Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd), Mumbai, 400030, India Tablet, Film-coated 250mg 18 Dec 2018
    HP003 Sofosbuvir Hepatitis European Egyptian Pharmaceuticals Industries Co, PO Box 111, El Manshia Alex, Cairo Desert Road KM 25, Amriya, Alexandria, Egypt Tablet, Film-coated 400mg 18 Dec 2018
    MA068 Pyrimethamine/Sulfadoxine + Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Tablets + Tablets 25mg/500mg + 100mg 18 Dec 2018
    MA135 Artesunate + Sodium Bicarbonate + Sodium Chloride Malaria Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India Powder, solvent and diluent for solution for injection 60mg + 5%w/v + 0.9%w/v 18 Dec 2018
    TB342 Moxifloxacin (hydrochloride) Tuberculosis Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Tablet, Dispersible 100mg 18 Dec 2018
    TB350 Linezolid Tuberculosis Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet, Film-coated 600mg 18 Dec 2018
    HA664 Darunavir HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 800mg 31 Oct 2018
    HA678 Dolutegravir (Sodium) HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 50mg 31 Oct 2018
    HA721 (a) Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 400mg/300mg/300mg 31 Oct 2018
    MA113 Pyrimethamine/Sulfadoxine Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Tablet 25mg/500mg 31 Oct 2018
    MA132 Amodiaquine (hydrochloride)/Artesunate Malaria Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 67.5mg/25mg 31 Oct 2018
    MA133 Amodiaquine (hydrochloride)/Artesunate Malaria Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India Tablet 135mg/50mg 31 Oct 2018
    CSVMedicines/Finished Pharmaceutical Products