Supplier/ Manufacturer(s) Unit III Jeedimetla, Hyderabad & UNIT V, Telengana. Hetero labs limited Varichem Pharmaceuti cals Varichem Pharmaceuti cals
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1 LIST OF DELISTED PRODUCTS Not eligible for procurement with the Global Fund resources 15th July Delisted July March March Sulfadoxine + Pyrimethamine 500mg + 25mg Tablet Remedica Limassol Cyprus 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 Hetero labs limited Varichem Pharmaceuti cals Varichem Pharmaceuti cals Linezolid 600mg Tablet Macleods Unit III Jeedimetla, Hyderabad & UNIT V, Telengana Al/PVC blister PE container 1*3 tabs and, * 3tabs 0's and 00's Lack of traceability of API supplier 30 No longer tentatively approved by USFDA Harare Zimbabwe 60 Deliested WHO PQ list Harare Zimbabwe 60 Deliested WHO PQ list 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 Abacavir (ABC) as sulfate 60 mg Tablet Oct Efavirenz (EFV) 0 mg Capsule Oct Zidovudine 60mg Tablet Oct Efavirenz + [Lamivudine + Stavudine] 600 mg + [150 mg + 30 mg] Tablet Laboratories Unit Survey No 313 Bachyupally, Quthubullapur Unit Survey No. 313 &314 UNIT- Survey No. 313 and 314, Bachupally Quthubullapur Unit-VII (SEZ), Mahaboob ; ; ; Alu/Alu blister; Cardboard box 60, 00; 30; 60, 00; 2+1; Sunpharm by not completed. Oct Indinavir (IDV) as Sulfate 400 mg Capsule Laboratories HDPE Container 90, 180 Sunpharm by not completed. Oct Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Tablet Laboratories, 60 Sunpharm by not completed. Oct Lamivudine + Stavudine 150 mg + 30 mg Tablet Laboratories ; 60 ; Sunpharm by not completed. Oct Stavudine (d4t) 30 mg Capsule Laboratories ; 60; 60 Sunpharm by not completed. List of delisted products, 1/5
2 Oct Efavirenz + [Lamivudine + Zidovudine] 600 mg + [150 mg mg] Tablet Laboratories Alu/Alu blister; Cardboard box blister contains two lamivudine 150mg and zidovudine 300mg tablets and one efavirenz 600mg tablet. Sunpharm by not completed. Oct 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 Ethambutol 400 mg Film coated tablet Svizera Turbe, Navi, Mumbai 00, Oct Ethambutol + Isoniazid +Rifampicin 275mg +75mg +150mg Tablet Svizera Turbe, Navi, Mumbai 00 Oct Ethambutol + Isoniazid + Pyrazinamide + Rifampicin 275 mg + 75 mg mg mg Tablet Svizera Turbe, Navi, Mumbai 00 Oct 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 0,500 92, Sipcot Industrial Complex, Hosur Artesunate+Amodiaquin (as hydrochloride as dihydrate) 25mg+67.5mg FDC tablet Cipla Cipla - Patalganga unit II 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 Block No. 2, Baddi, Solan 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 requested since 5 approved products available in the GF list extended Atazanavir+Ritonavir 300mg+0mg Tablet (FDC) Emcure Hinjwadi, Pune Mefloquine 250mg Tablet Mepha Sofarimex Industria Quimica e Farmaceutica, Agualva-Cacém Portugal 4, 6 Delisted. Mepha is now owned by Acino. Acino discontinued the SRA approval under Mepha. 8 s pack Acino however is still retained List of delisted products, 2/5
3 41852 Lamivudine+Tenofovir disoproxil fumarate + Nevirapine ( mg) + 200mg Co-ed tablets 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 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 C0 blister 2g, 4g On Voluntary request manufacturer. 60 On Voluntary request manufacturer. 60 On Voluntary request manufacturer. 200ml On Voluntary request manufacturer Artesunate + (Sulfadoxine+Pyrimethamine) Co ed 0mg+ (500mg+25mg) Tablet Co-blister Guilin Guilin Co. No. 43 Quilidian road, Guilin China Co-packed (6+3) Linezolid 600mg Tablet Hetero Labs limited 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 limited Hetero Labs Limited (unit-iii) 22-1, IDA Jeedimetla, Hyderabad , A.P., INDIA 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 extended 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 Dholka- Gujarat 0500 Limited Unit VII (SEZ) Mahaboob Nagar (DT), Andhra Unit Survey No. 313 &314 Unit III Survey No. 313, ml 240ml On Voluntary request manufacturer. Reinstated after variation approval On Voluntary request manufacturer. List of delisted products, 3/5
4 Nevirapine (NVP) 50 mg /5 ml Oral Suspension Zidovudine 50mg/5ml Oral solution Prothionamide 250mg Tablet Unit III Survey No. 313 and 314 Bachupally Quthubullapur Mandal, Hyderabad Andhra Unit III Survey No. 313, Dholka, Ahmedabad, 240ml 0ml, 240ml Alu/PVC 0 On Voluntary request manufacturer. Reinstated after variation approval in 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 limited 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 Efavirenz+Emtricitabine+Tenofovir disoproxil fumarate 600mg+200mg+300mg Tablets Hetero Labs limited 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 limited Hyderabad, UNIT-V PVC/Alu blister Levofloxacin 500mg Tablet Hetero Labs limited Hyderabad, UNIT-V PVC/Alu blister Ofloxacin 200mg Tablet Microlabs Hosur Ofloxacin 400mg Tablet Microlabs Hosur Pyrazinamide 500mg Tablet Macleods Kachigam, Damam 00 List of delisted products, 4/5
5 41426 Darunavir 400mg Tablet Hetero Labs limited UNIT- Hyderabad Darunavir 600mg Tablet Hetero Labs limited 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 HDPE pack; s 00; 491 Ethambutol 0mg Tablet Macleods kachigam, Damam ; s 00;, 461 Nevirapine 50 mg Despersible Tablet Cipla Patalganga ; Blsiter 60, 00; 461 Nevirapine 0 mg Despersible Tablet Cipla Patalganga ; Blsiter 60, 00; List of delisted products, 5/5
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