Supplier/ Manufacturer(s) Unit III, Survey No 51, Plot No IDA, Jeedimetla, Hyderabad, Telangana, Hetero labs limited

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1 LIST OF DELISTED PRODUCTS Not eligible for procurement with the Global Fund resources 06th of April 2018 Delisted Mar-18 Ritonavir (RTV) 0 mg Tablet Unit Survey No 51, Plot No 22-1 IDA, Jeedimetla, Hyderabad, Telangana, x1; 120x1 WHO Prequalification Mar-18 Zidovudine 300mg Tablets Macleods Kachigam, Daman, PVDC/PVC/Alu blister; ; 60 Mar-18 Levofloxacin 0mg disp tablet Macleods Block N2 Village Theda, P.O. Lodhimajra, Tehsil Baddi, District:-Solan Himachal pack Alu/Alu strip pack x x Product WHO PQ on the 22nd of February 2018 Mar-18 Artesunate 0mg Suppository Cipla Limited Cipla Limited, D7, MIDC Industrial area Kurkumbh Dist Pune INDIA Alu/Alu 2' Product WHO PQ on the 22nd of February 2018 February 2018 Sofosbuvir 400 mg tablet Limited Limited, Unit-V, Jadcherla, Mahaboobnagar , Telangana State Product WHO PQ on the 07th of February Abacavir (ABC) as sulfate 20 mg / ml Oral Solution Cipla Dec-2017 Rifampicin +Isoniazid + Pyrazinamide 75mg+50mg+ 150mg disp tablet Macleods Oct-17 Kanamycin sulfate 0.5g Powder for Injection Hisun Pharmaceutica ls, China List of delisted products, 06th March /6 Cipla Limited, L-139 to L-146 Verna Goa; Indore Phase II, Unit II, Plot No , Premier Ind. Estate, Hisun Kachigam, Daman (Hangzhou) Co., Xialian Village, Xukou Town, Fuyang City, Hangzhou City, Zhejiang Provine 240ml, 0ml container pack Alu/Alu strip pack 0 (3x), (x), China Glass vial ml Product WHO PQ on the 12th of december 2017

2 Oct-17 Kanamycin sulfate 1 g Powder for Injection Oct-17 Linezolid 600 mg tablet Oct-17 Zidovudine 300mg Tablets Hisun Pharmaceutica ls, China Macleods Pharmaceutica ls, Hisun (Hangzhou) Co., Xialian Village, Xukou Town, Fuyang City, Hangzhou City, Zhejiang Provine Macleods Plock N-2, Vill. Theda, P.O. Lodhimajra, Baddi, Dist. Solan (H.P) Unit- 22-1, Industrial Development Area, Jeedimetla, Hyderabad China Glass vial ml pack; Strip pack *; *, 5*4 60, 500, 600 Oct-17 Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Tablet Unit- Jeedimetla, Hyderabad, Andhra, ; Unit-V, Mahaboob Nagar, Andhra, 60, 0, 500 Oct-17 Levofloxacin 500mg Tablet Oct-17 Levofloxacin 250mg Tablet Oct-17 Ethambutol + Isoniazid 400mg+150mg Tablet Oct-17 Isoniazid + Rifampicin 75 mg mg Tablet Oct-17 Mai 2017 March March Ethambutol + Isoniazid + Pyrazinamide + Rifampicin 275 mg + 75 mg mg mg Tablet Hetero Europe SL, Spain Hetero Labs, Hetero Europe SL Spain Lupin Strides Arcolab ltd Strides Arcolab ltd Ethionamide 125mg disp tablet Macleods Efavirenz+ Lamivudine + Tenofovir Disoproxil Fumarate 600 mg mg mg Tablet Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Tablet Lamivudine + Zidovudine 150 mg mg Tablet Varichem Pharmaceutic als Varichem Pharmaceutic als Hetero Labs Unit V Andra Hetero Labs Unit V Andra Aurangabad Strides Arcolab, Bangalore Strides Arcolab, Bangalore; Phase II, Unit II, Sr No. 366, Premier Ind. Estate, Kachigam, Daman Unit III Jeedimetla, Hyderabad & UNIT V, Telengana ; HDPE bottle; Al/PVC/Aclar blister ;HDPE bottle; Al/PVC/Aclar Alu/PVC/PVDC blister ; Alu/PVC/PVdc ; Alu/PVC/PVdc Alu/Alu strip pack 5,; 50; x ; 50; x ,00, 00, 5x6 Deliested WHO PQ list Deliested WHO PQ list Deliested WHO PQ list WHO PQ in the meantime 30 No longer tentatively approved by USFDA Harare Zimbabwe 60 Deliested WHO PQ list Harare Zimbabwe 60 Deliested WHO PQ list List of delisted products, 06th March /6

3 Linezolid 600mg Tablet Macleods Solan Himachal alu/pvc blister ERP validity period until 31 dec The product is classified under CAT-3 and hence will be delisted. Cycloserine 250 mg Capsule Aspen Pharmacare Aspen Pharmacare Port Elizabeth South Africa 0 De listed WHO PQ list Oct 2015 Abacavir (ABC) as sulfate 60 mg Tablet Unit Survey No 313 Bachyupally, Quthubullapur ; 60, 00; Oct 2015 Efavirenz (EFV) 0 mg Capsule Unit Survey No. 313 &314 ; 30; Oct 2015 Zidovudine 60mg Tablet Oct 2015 Efavirenz + [Lamivudine + Stavudine] 600 mg + [150 mg + 30 mg] Tablet Oct 2015 Indinavir (IDV) as Sulfate 400 mg Capsule Oct 2015 Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Tablet Oct 2015 Lamivudine + Stavudine 150 mg + 30 mg Tablet Oct 2015 Stavudine (d4t) 30 mg Capsule Laboratories Laboratories Laboratories Laboratories Laboratories UNIT- Survey No. 313 and 314, Bachupally Quthubullapur Unit-VII (SEZ), Mahaboob Paonta Sahib, Himachal ; Alu/Alu blister; Cardboard box 60, 00; 2+1; Paonta Sahib, Himachal HDPE Container 90, 180 Paonta Sahib, Himachal, 60 Paonta Sahib, Himachal Paonta Sahib, Himachal ; ; 60 ; 60; 60 Oct 2015 Efavirenz + [Lamivudine + Zidovudine] 600 mg + [150 mg mg] Tablet Laboratories Paonta Sahib, Himachal Alu/Alu blister; Cardboard box blister contains two lamivudine 150mg and zidovudine 300mg tablets and one efavirenz 600mg tablet. Oct 2015 Efavirenz + Emtricitabine + Tenofovir 600 mg mg mg Tablet Emcure Limited Plot No. P-1 & P-2, I.T.-B.T. Park, Phase II, MIDC, Hinjwadi, PUNE 30 Delisted in PEPFAR lists Oct 2015 Ethambutol 400 mg Film coated tablet Svizera Turbe, Navi, Mumbai 00, Oct 2015 Ethambutol + Isoniazid +Rifampicin 275mg +75mg +150mg Tablet Svizera Turbe, Navi, Mumbai 00 Oct 2015 Ethambutol + Isoniazid + Pyrazinamide + Rifampicin 275 mg + 75 mg mg mg Tablet Svizera Turbe, Navi, Mumbai 00 Oct 2015 Isoniazid+Rifampicin 75mg+150mg Tablet Svizera Turbe, Navi, Mumbai Levofloxacin 750mg Tablet IPCA Pithampur Madhya Clarithromycin 250mg Tablet Microlabs Hosur April Cycloserine 250mg Capsule Microlabs Artemether+Lumefantrine mg Dispersible tablet Microlabs Plot No: S-155 to S-159Verna, Goa 30 0,500 92, Sipcot Industrial Complex, Hosur Artesunate+Amodiaquin (as hydrochloride as dihydrate) 25mg+67.5mg FDC tablet Cipla Cipla - Patalganga unit II 8 0 requested since 5 approved products available in the GF list List of delisted products, 06th March /6

4 42005 Artesunate+Amodiaquin (as hydrochloride as dihydrate) 50mg+135mg FDC tablet Cipla Cipla - Patalganga unit II Artesunate+Amodiaquin (as hydrochloride as dihydrate) 0mg+270mg FDC tablet Cipla Cipla - Patalganga unit II Levofloxacin 250mg Tablet Macleods Levofloxacin 500mg Tablet Macleods Block No. 2, Baddi, Solan Levofloxacin 750mg Tablet Macleods Block No. 2, Baddi, Solan Nevirapine 20mg MicroLabs Nevirapine 50mg MicroLabs Nevirapine 0mg MicroLabs Atazanavir+Ritonavir 300mg+0mg Tablet (FDC) Emcure Mefloquine 250mg Tablet Mepha Lamivudine+Tenofovir disoproxil fumarate + Nevirapine ( mg) + 200mg Co-ed tablets Didanosine (ddi) Didanosine (ddi) Didanosine (ddi) Stavudine (d4t) mg / ml 0 mg 200 mg 1 mg / ml Powder for Oral Solution Tablets for Oral Suspension Tablets for Oral Suspension Poweder for Oral Solution Artesunate + (Sulfadoxine+Pyrimethamine) Co ed 0mg+ (500mg+25mg) Tablet Co-blister Guilin Goa Goa Goa ,60, ,60, ,60,90 Hinjwadi, Pune 30 Sofarimex Industria Quimica e Farmaceutica, Agualva-Cacém Limited, Unit VII (SEZ) Andhra Unit Survey 313 & 314, Unit - III Survey No. 313 & 314, Unit - III Survey No. 313 & 314, Unit Survey No. 313 &314 Guilin Co. No. 43 Quilidian road, Guilin Portugal 4, 6 C0 blister Delisted. Mepha is now owned by Acino. Acino discontinued the SRA approval under Mepha. 8 s pack Acino however is still retained 2g, 4g On Voluntary request manufacturer. 60 On Voluntary request manufacturer. 60 On Voluntary request manufacturer. 200ml On Voluntary request manufacturer. China Co-packed (6+3) Linezolid 600mg Tablet Hetero Labs Hetero Labs Limited (Unit-V), Andhra 20, Moxifloxacin (as Hydrochloride) 400mg Tablet Sandoz Sandoz Private Limited, Navi Mumbai PVC/PVdC/Alu blister Lamivudine+Zidovudine 30mg+60mg Tablet (FDC) Microlabs Micro Labs Limited Goa ,0, Raltegravir 400mg Tablet Hetero Labs Hetero Labs Limited (unit-iii) 22-1, IDA Jeedimetla, Hyderabad , A.P., INDIA 60 List of delisted products, 06th March /6

5 41791 Zidovudine 60mg Tablet Microlabs Micro Labs Limited Goa ,0,500, Lopinavir+Ritonavir 40mg/mg Capsule Cipla May Plot L147 to L-147-1, Verna Industrial Estate, Verna, Goa Cycloserine 250mg Capsule Lupin Aurangabad Ritonavir 0mg Tablet Cipla Patalganga Ofloxacin 200mg Tablet Dholka- Gujarat 50, 0, Ofloxacin 400mg Tablet Efavirenz+Lamivudine+Tenofovir disoproxil fumarate 600mg+300mg+300mg Tablets Abacavir (ABC) 20 mg / ml Oral Solution Lamivudine (3TC) mg / ml Oral Solution Nevirapine (NVP) 50 mg /5 ml Oral Suspension Zidovudine 50mg/5ml Oral solution Prothionamide 250mg Tablet Dholka- Gujarat 0500 Limited Unit VII (SEZ) Mahaboob Nagar (DT), Andhra Unit Survey No. 313 &314 Unit III Survey No. 313, Unit III Survey No. 313 and 314 Bachupally Quthubullapur Mandal, Hyderabad Andhra Unit III Survey No. 313, Dholka, Ahmedabad, ml 240ml 240ml 0ml, 240ml Alu/PVC 0 On Voluntary request manufacturer. Reinstated after variation approval On Voluntary request manufacturer. On Voluntary request manufacturer. Reinstated after variation approval in 2015 On Voluntary request manufacturer. Reinstated after variation approval Ethambutol + Isoniazid 400mg+150mg Tablet Lupin Aurangabad Ethambutol + Isoniazid +Rifampicin 275mg +75mg +150mg Tablet Lupin Aurangabad Isoniazid+Rifampicin 75mg+150mg Tablet Dholka, Ahmedabad, Alu/ blister 00, Isoniazid+Rifampicin 150mg+150mg Tablet Lupin Aurangabad Moxifloxacin (as Hydrochloride) 400mg Tablets Hetero Labs Hyderabad, UNIT-V Alu/Alu cold form blister. s Ethambutol + Isoniazid +Rifampicin 275mg +75mg +150mg Tablet Svizera Turbe, Navi, Mumbai Lamivudine+Tenofovir disoproxil fumarate + Nevirapine ( mg) + 200mg Co-ed tablets Macleods Kachigam, Damam cold form Laminate and Aluminium Foil co packed blisters Ethionamide 250mg Tablet Lupin Aurangabad ; AL/LDPE 0; Moxifloxacin 400mg Tablet Macleods Kachigam Daman s Prothionamide 250mg Tablet Lupin Aurangabad 50 List of delisted products, 06th March /6

6 41456 Efavirenz+Emtricitabine+Tenofovir disoproxil fumarate 600mg+200mg+300mg Tablets Hetero Labs Unit V, SEZ,Mahaboob Nagar Dist , Andhra Lamivudine+Nevirapine+Zidovudine 30mg+50mg+60mg Tablet for Oral suspension Cipla Verna Goa 60, Ethambutol + Isoniazid + Pyrazinamide + Rifampicin 275 mg + 75 mg mg mg Tablet Svizera Turbe, Navi, Mumbai Isoniazid+Rifampicin 75mg+150mg Tablet Svizera Turbe, Navi, Mumbai Levofloxacin 250mg Tablet Hetero Labs Hyderabad, UNIT-V PVC/Alu blister Levofloxacin 500mg Tablet Hetero Labs Hyderabad, UNIT-V PVC/Alu blister Ofloxacin 200mg Tablet Microlabs Hosur Ofloxacin 400mg Tablet Microlabs Hosur Pyrazinamide 500mg Tablet Macleods Kachigam, Damam Darunavir 400mg Tablet Hetero Labs UNIT- Hyderabad Darunavir 600mg Tablet Hetero Labs UNIT- Hyderabad Prothionamide 250mg Tablet Microlabs Hosur ; Bottle 14; Darunavir (TCM) 300 mg Tablet Tibotec Inc sen Ortho LLc, Gurabo Puerto Rico 120 by manufacturer Atazanavir 0 mg Capsule Cipla Goa Atazanavir 200 mg Capsule Cipla Goa Atazanavir 300 mg Capsule Cipla Goa Ethambutol 400mg Tablet Svizera Navi Mumbai 491 Ethambutol 0mg Tablet Macleods kachigam, Damam 461 Nevirapine 50 mg Despersible Tablet Cipla Patalganga 461 Nevirapine 0 mg Despersible Tablet Cipla Patalganga HDPE pack; s ; s ; Blsiter ; Blsiter 00; 00;, 60, 00; 60, 00; List of delisted products, 06th March /6