Short dated tender - Tender For Supply Of Anti Cancer Items - 1 2 M/s. NATCO PHARMA LTD. ,Hyderabad 1 D33256 Inj. Zoledronic Acid 5mg / vial Invalid Mfg. License, No WHO GMP Certificate, No Market Standing and Non Conviction certificate not submitted as per clause No. 5.2.1. , 5.2.2., 5.2.9. & 5.2.10. respectively. Not Qualified. Tab. Eltrombopag Olamine 25 mg/Tab (Aluminium foil/Blister pack) 2 D16040 Qualified. Tab./Cap. Imatinib (Aluminium 100 mg/Tab./Cap foil/Blister pack) 3 D33075 Qualified. Tab. Imatinib(Aluminium 400 mg/Tab foil/Blister pack) 4 D33076 Qualified. 5 D33083 Inj. Bendamustine 100mg Qualified. 6 D33087 Inj. Bortezomib 2mg / Vial Qualified. Tab. Capecitabine (Aluminium 500mg/ Tab Foil/Blister Pack) 7 D33091 Qualified. 8 D33105 Inj. Decitabine 50mg / Vial Qualified. Tab. Letrozole (Aluminium 2.5mg/ Tab foil/Blister pack) 9 D33135 Qualified. 10 D33161 Inj. Pemetrexed 100 mg / Vial Qualified. 11 D33162 Inj. Pemetrexed 500 mg / Vial Qualified. Tab. Sorafenib (Aluminium 200mg/ Tab foil/Blister pack) 12 D33167 Qualified. 13 D33181 Inj. Zoledronic Acid 4 mg / Vial Qualified. 2 3 M/s. MSN LABORATORIES PVT. LTD. ,Hyderabad Cap. Palbociclib (Aluminium 125mg/Cap. foil/Blister pack) 1 D33249 No Market Standing as per clause No. 5.2.9. Not Qualified. Tab. Tapentadol (Aluminium 50mg /Tab foil/Blister pack) 2 D33253 Qualified. Tab. Tapentadol (Aluminium 100mg / E. R. Tab foil/Blister pack) 3 D33254 Qualified. Tab. Eltrombopag Olamine 25 mg/Tab (Aluminium foil/Blister pack) 4 D16040 No Market Standing as per clause No. 5.2.9. Not Qualified. Tab./Cap. Nilotinib (Aluminium 200 mg/Tab./Cap foil/Blister pack) 5 D33150 No Market Standing as per clause No. 5.2.9. Not Qualified. Tab. Pazopanib (Aluminium 200mg/ Tab foil/Blister pack) 6 D33160 No Market Standing as per clause No. 5.2.9. Not Qualified. 7 D33195 Inj. Azacitidine (with diluents) 100 mg/Vial Qualified. Tab. Abiraterone (Aluminium 250 mg / Tab. foil/Blister pack) 8 D33209 Qualified. Tab. Cabozantinib (Aluminium 60mg/Tab. foil/Blister pack) 9 D33240 Qualified. Tab. Cabozantinib (Aluminium 20 mg/Tab. foil/Blister pack) 10 D33241 Qualified. 3 4 M/s. NOVARTIS HEALTHCARE PVT. LTD. ,Chennai Tab. Eltrombopag Olamine 25 mg/Tab (Aluminium foil/Blister pack) 1 D16040 Qualified. Tab./Cap. Nilotinib (Aluminium 200 mg/Tab./Cap foil/Blister pack) 2 D33150 Qualified. 1 Sl No. Name of the Item Specification Reason for Rejection Remarks 4 5 M/s. INTAS PHARMACEUTICALS LTD. ,Ahmedabad 1 D33055 Inj. Carboplatin 150MG 10 mg / ml Qualified. 2 D33056 Inj. Carboplatin 450MG 10 mg / ml Qualified. Tab. Bicalutamide (Aluminium 50mg/Tab Foil/Blister Pack) 3 D33085 Qualified. Tab. Capecitabine (Aluminium 500mg/ Tab Foil/Blister Pack) 4 D33091 Qualified. 5 D33097 Inj. Cytarabine (with diluents) 100mg / vial Qualified. 6 D33098 Inj. Cytarabine (with diluents) 1GM / VIAL Qualified. 7 D33107 Inj. Docetaxel (with diluents) 20mg / Vial Qualified. 8 D33108 Inj. Docetaxel (with diluents) 80mg / Vial Qualified. 9 D33122 Inj. Filgrastim 300mcg/ Vial Qualified. 10 D33123 Inj. Filgrastim peg 6mg/ PFS Qualified. Tab. Letrozole (Aluminium 2.5mg/ Tab foil/Blister pack) 11 D33135 Qualified. 12 D33164 Inj. Rituximab 100 mg / Vial Qualified. 13 D33165 Inj. Rituximab 500 mg / Vial Qualified. Inj. Trastuzumab (with diluets in 440mg one kit pack) 14 D33177 Qualified. 15 D33195 Inj. Azacitidine (with diluents) 100 mg/Vial Qualified. 16 D33210 Inj. Denosumab 120mg Qualified. Inj. Bevacizumab (with diluents in 25mg/ml plastic container) 100mg 17 D33214 Qualified. Inj. Bevacizumab (with diluents in 25mg / ml plastic container) 400mg 18 D33215 Qualified. Inj. Trastuzumab (with diluets) in 150mg/vial one pack 19 D33224 Qualified. 5 6 M/s. MEDICAMEN BIOTECH LTD. ,New Delhi Cap. Palbociclib (Aluminium 125mg/Cap. foil/Blister pack) 1 D33249 No Market Standing as per clause No. 5.2.9. Not Qualified. Tab. Eltrombopag Olamine 25 mg/Tab (Aluminium foil/Blister pack) 2 D16040 No Market Standing as per clause No. 5.2.9. Not Qualified. 3 D33087 Inj. Bortezomib 2mg / Vial Qualified. Tab. Dasatinib (Aluminium 50 mg/ Tab. Foil/Blister Pack) 4 D33100 Qualified. Tab. Erlotinib (Aluminium 150mg/ Tab foil/Blister pack) 5 D33116 Qualified. Cap. Lenalidomide (Aluminium 10mg/ Cap foil/Blister pack) 6 D33132 Qualified. Tab. Pazopanib (Aluminium 200mg/ Tab foil/Blister pack) 7 D33160 Qualified. 8 D33161 Inj. Pemetrexed 100 mg / Vial Qualified. 9 D33162 Inj. Pemetrexed 500 mg / Vial Qualified. Cap. Temozolamide (Aluminium 100mg/ Cap foil/Blister pack) 10 D33170 Qualified. Cap. Temozolamide (Aluminium 250mg/ Cap foil/Blister pack) 11 D33172 Qualified. Tab. Abiraterone (Aluminium 250 mg / Tab. foil/Blister pack) 12 D33209 Qualified. Tab. Dasatinib (Aluminium 20 mg/ Tab. Foil/Blister Pack) 13 D33213 Qualified. Cap. Lenvatinib (Aluminium 4mg/Cap. foil/Blister pack) 14 D33248 Qualified. 2 Sl No. Name of the Item Specification Reason for Rejection Remarks 6 7 M/s. JODAS EXPOIM PVT. LTD. ,Hyderabad 1 D33126 Inj. Fulvestrant 250 mg/PFS No WHO GMP as per clause No. 5.2.2. Not Qualified. 2 D33195 Inj. Azacitidine (with diluents) 100 mg/Vial No WHO GMP as per clause No. 5.2.2. Not Qualified. 3 Sl No. Name of the Item Specification Reason for Rejection Remarks 7 8 M/s. BETA DRUGS LTD. ,Haryana Cap. Palbociclib (Aluminium 125mg/Cap. foil/Blister pack) 1 D33249 No Market Standing as per clause No. 5.2.9. Not Qualified. Tab. Eltrombopag Olamine 25 mg/Tab (Aluminium foil/Blister pack) 2 D16040 No Market Standing as per clause No. 5.2.9. Not Qualified. 3 D33023 Inj. Cisplatin 10 mg/Vial Qualified. 4 D33024 Inj. Cisplatin 50 mg / vial Qualified. 5 D33055 Inj. Carboplatin 150MG 10 mg / ml Qualified. 6 D33056 Inj. Carboplatin 450MG 10 mg / ml Qualified. 7 D33059 Inj. Epirubicin 10mg / Vial Qualified. 8 D33060 Inj. Epirubicin 50mg / Vial Qualified. Inj. Etoposide (with diluents in 100mg/Vial plastic container) 9 D33071 Qualified. Inj. Gemciatbine (with diluents in 200mg/vial plastic container) 10 D33072 Qualified. Inj. Gemciatbine (with diluents in 1gm/vial plastic container) 11 D33073 Qualified. Tab. Imatinib(Aluminium 400 mg/Tab foil/Blister pack) 12 D33076 Qualified. Inj. Paclitaxel (with transfusion set 260mg /Vial (PVC and DEHP free Administration set,EVA administration set with 0.2 micro meter filter for drugs and solutions incompatible with PVC, A 13 D33079 Qualified. Each Kit contain ( 125 mg - 1 Tab./Cap. And 80 mg - 2 Tab./Cap.) 14 D33081 Tab./Cap. Aprepetant Qualified. 15 D33083 Inj. Bendamustine 100mg Qualified. 16 D33087 Inj. Bortezomib 2mg / Vial Qualified. Tab. Capecitabine (Aluminium 500mg/ Tab Foil/Blister Pack) 17 D33091 Qualified. 18 D33107 Inj. Docetaxel (with diluents) 20mg / Vial Qualified. 19 D33108 Inj. Docetaxel (with diluents) 80mg / Vial Qualified. 20 D33109 Inj. Docetaxel (with diluents) 120 mg / Vial Qualified. Tab. Erlotinib (Aluminium 150mg/ Tab foil/Blister pack) 21 D33116 Qualified. Tab. Gefitinib (Aluminium 250mg/ Tab foil/Blister pack) 22 D33127 Qualified. 23 D33136 Inj. Leucovorin Calcium 50mg/vial Qualified. Tab./Cap. Nilotinib (Aluminium 200 mg/Tab./Cap foil/Blister pack) 24 D33150 Qualified. 25 D33152 Inj. Oxaliplatin 50 mg / Vial Qualified. 26 D33153 Inj. Oxaliplatin 100 mg / Vial Qualified. Inj. Paclitaxel (with transfusion set 100 mg / Vial (PVC and DEHP free Administration set,EVA administration set with 0.2 micro meter filter for drugs and solutions incompatible with PVC, A 27 D33156 Qualified. Tab. Pazopanib (Aluminium 200mg/ Tab foil/Blister pack) 28 D33160 Qualified. 29 D33161 Inj. Pemetrexed 100 mg / Vial Qualified. 30 D33162 Inj. Pemetrexed 500 mg / Vial Qualified. Tab. Sorafenib (Aluminium 200mg/ Tab foil/Blister pack) 31 D33167 Qualified. 4 Sl No. Name of the Item Specification Reason for Rejection Remarks Cap. Temozolamide (Aluminium 100mg/ Cap foil/Blister pack) 32 D33170 Qualified. Cap. Temozolamide (Aluminium 20mg / Cap foil/Blister pack) 33 D33171 Qualified. Cap. Temozolamide (Aluminium 250mg/ Cap foil/Blister pack) 34 D33172 Qualified. 35 D33195 Inj. Azacitidine (with diluents) 100 mg/Vial Qualified. Tab. Lapatinib (Aluminium 250mg/Tab foil/Blister pack) 36 D33208 Qualified. Tab. Abiraterone (Aluminium 250 mg / Tab. foil/Blister pack) 37 D33209 Qualified. 38 D33212 Inj. Nab Paclitaxel (with diluents) 100 mg / Vial Qualified. Tab. Cabozantinib (Aluminium 60mg/Tab. foil/Blister pack) 39 D33240 Qualified. Cap. Enzalutamide (Aluminium 40mg/Cap. foil/Blister pack) 40 D33244 Qualified. 8 9 M/s. SUN PHARMA LABORATORIES LTD. ,Mumbai 1 D33192 Buprenorphine Patch 5mcg/hour, 7 days patch No Drugs endorsement available on the behalf of M/s. Sun Pharma Laboratories. Not Qualified. 2 D33193 Buprenorphine Patch 10mcg/hour, 7 days patch No Drugs endorsement available on the behalf of M/s. Sun Pharma Laboratories. Not Qualified. 3 D33220 Inj. Liposomal Doxorubicin 20 mg /vial Invalid Mfg. License, No Market Standing and Non Conviction certificate not submitted as per clause No. 5.2.1. , 5.2.9. & 5.2.10. respectively. Not Qualified. Cap. Lenvatinib (Aluminium 4mg/Cap. foil/Blister pack) 4 D33248 No Market Standing as per clause No. 5.2.9. Not Qualified. 9 10 M/s. NANZ MEDSCIENCE PHARMA PVT. LTD. ,Paonta Sahib (HP) Chlorhexidine Gluconate solution 0.2% w/v (mouth wash) 1 D33219 Qualified. 5 Sl No. Name of the Item Specification Reason for Rejection Remarks 10 11 M/s. FRESENIUS KABI ONCOLOGY LTD. ,Pune 1 D33015 Inj. Doxorubicin HCl 2 mg / ml Qualified. 2 D33054 Inj. Doxorubicin HCl 2mg/ ml Qualified. 3 D33055 Inj. Carboplatin 150MG 10 mg / ml Qualified. 4 D33056 Inj. Carboplatin 450MG 10 mg / ml Qualified. Inj. Gemciatbine (with diluents in 200mg/vial plastic container) 5 D33072 Qualified. Inj. Gemciatbine (with diluents in 1gm/vial plastic container) 6 D33073 Qualified. Inj. Paclitaxel (with transfusion set 260mg /Vial (PVC and DEHP free Administration set,EVA administration set with 0.2 micro meter filter for drugs and solutions incompatible with PVC, A 7 D33079 Qualified. 8 D33083 Inj. Bendamustine 100mg Qualified. 9 D33107 Inj. Docetaxel (with diluents) 20mg / Vial Qualified. 10 D33108 Inj. Docetaxel (with diluents) 80mg / Vial Qualified. 11 D33109 Inj. Docetaxel (with diluents) 120 mg / Vial Qualified. 12 D33152 Inj. Oxaliplatin 50 mg / Vial Qualified. 13 D33153 Inj. Oxaliplatin 100 mg / Vial Qualified. Inj. Paclitaxel (with transfusion set 100 mg / Vial (PVC and DEHP free Administration set,EVA administration set with 0.2 micro meter filter for drugs and solutions incompatible with PVC, A 14 D33156 Qualified. 15 D33211 inj. Irinotecan 100 mg Qualified. 16 D33212 Inj. Nab Paclitaxel (with diluents) 100 mg / Vial Qualified. Inj. Paclitaxel nanoparticle (with 80mg / vial diluents) 17 D33223 Qualified. 6 Sl No. Name of the Item Specification Reason for Rejection Remarks 11 12 M/s. KHANDELWAL LABORATORIES PVT. LTD. ,Mumbai 1 D33015 Inj. Doxorubicin HCl 2 mg / ml Qualified. 2 D33023 Inj. Cisplatin 10 mg/Vial Qualified. 3 D33024 Inj. Cisplatin 50 mg / vial Qualified. Tab./Cap. Etoposide(Aluminium 50 mg/Tab./Cap foil/Blister pack) 4 D33035 Qualified. Tab. Tamoxifen (Aluminium 10 mg/ Tab. foil/Blister pack) 5 D33040 Qualified. Tab. Tamoxifen (Aluminium 20 mg/ Tab foil/Blister pack) 6 D33041 Qualified. 7 D33054 Inj. Doxorubicin HCl 2mg/ ml Qualified. 8 D33055 Inj. Carboplatin 150MG 10 mg / ml Qualified. 9 D33056 Inj. Carboplatin 450MG 10 mg / ml Qualified. 10 D33059 Inj. Epirubicin 10mg / Vial Qualified. 11 D33060 Inj. Epirubicin 50mg / Vial Qualified. Inj. Bleomycin (with diluents in 15 IU/vial plastic container) 12 D33069 Qualified. Inj. Etoposide (with diluents in 100mg/Vial plastic container) 13 D33071 Qualified. Inj. Gemciatbine (with diluents in 200mg/vial plastic container) 14 D33072 Qualified. Inj. Gemciatbine (with diluents in 1gm/vial plastic container) 15 D33073 Qualified. Tab./Cap. Imatinib (Aluminium 100 mg/Tab./Cap foil/Blister pack) 16 D33075 Qualified. Tab. Imatinib(Aluminium 400 mg/Tab foil/Blister pack) 17 D33076 Qualified. Inj. Paclitaxel (with transfusion set 260mg /Vial (PVC and DEHP free Administration set,EVA administration set with 0.2 micro meter filter for drugs and solutions incompatible with PVC, A 18 D33079 Qualified. Tab Anastrozole (Aluminium 1 Mg Foil/Blister Pack) 19 D33080 Qualified. Each Kit contain ( 125 mg - 1 Tab./Cap. And 80 mg - 2 Tab./Cap.) 20 D33081 Tab./Cap. Aprepetant Qualified. 21 D33087 Inj. Bortezomib 2mg / Vial Qualified. Tab. Capecitabine (Aluminium 500mg/ Tab Foil/Blister Pack) 22 D33091 Qualified. 23 D33097 Inj. Cytarabine (with diluents) 100mg / vial Qualified. 24 D33098 Inj. Cytarabine (with diluents) 1GM / VIAL Qualified. 25 D33107 Inj. Docetaxel (with diluents) 20mg / Vial Qualified. 26 D33108 Inj. Docetaxel (with diluents) 80mg / Vial Qualified. 27 D33109 Inj. Docetaxel (with diluents) 120 mg / Vial Qualified. Tab. Erlotinib (Aluminium 150mg/ Tab foil/Blister pack) 28 D33116 Qualified. Tab. Gefitinib (Aluminium 250mg/ Tab foil/Blister pack) 29 D33127 Qualified. Tab. Letrozole (Aluminium 2.5mg/ Tab foil/Blister pack) 30 D33135 Qualified. 31 D33146 Inj. Methotrexate 50 mg / Vial Qualified. 32 D33152 Inj. Oxaliplatin 50 mg / Vial Qualified. 33 D33153 Inj. Oxaliplatin 100 mg / Vial Qualified. 7 Sl No. Name of the Item Specification Reason for Rejection Remarks Inj. Paclitaxel (with transfusion set 100 mg / Vial (PVC and DEHP free Administration set,EVA administration set with 0.2 micro meter filter for drugs and solutions incompatible with PVC, A 34 D33156 Qualified. 35 D33161 Inj. Pemetrexed 100 mg / Vial Qualified. 36 D33162 Inj. Pemetrexed 500 mg / Vial Qualified. Cap. Temozolamide (Aluminium 100mg/ Cap foil/Blister pack) 37 D33170 Qualified. Cap. Temozolamide (Aluminium 20mg / Cap foil/Blister pack) 38 D33171 Qualified. Cap. Temozolamide (Aluminium 250mg/ Cap foil/Blister pack) 39 D33172 Qualified. Cap. Thalidomide (Aluminium 100mg / Cap foil/Blister pack) 40 D33174 Qualified. 41 D33181 Inj. Zoledronic Acid 4 mg / Vial Qualified. Tab. Abiraterone (Aluminium 250 mg / Tab. foil/Blister pack) 42 D33209 Qualified. 43 D33211 inj. Irinotecan 100 mg Qualified. 12 13 M/s. SPARSHA PHARMA INTERNATIONAL PVT. LTD. ,Hyderabad 1 D33192 Buprenorphine Patch 5mcg/hour, 7 days patch Qualified. 2 D33193 Buprenorphine Patch 10mcg/hour, 7 days patch Qualified. 3 D33194 Fentanyl Patch 25 mcg/Patch Less Turnover as per clause No. 5.2.5. Not Qualified. 4 D33245 Fentanyl Patch 50 mcg/patch, Qualified. 13 14 M/s. ALBINO LIFESCIENCES PVT. LTD. ,New Delhi Cap. Palbociclib (Aluminium 125mg/Cap. foil/Blister pack) 1 D33249 No Market Standing as per clause No. 5.2.9. Not Qualified. 2 D33023 Inj. Cisplatin 10 mg/Vial No Market Standing as per clause No. 5.2.9. Not Qualified. 3 D33024 Inj. Cisplatin 50 mg / vial No Market Standing as per clause No. 5.2.9. Not Qualified. 4 D33055 Inj. Carboplatin 150MG 10 mg / ml No Market Standing as per clause No. 5.2.9. Not Qualified. 5 D33056 Inj. Carboplatin 450MG 10 mg / ml No Market Standing as per clause No. 5.2.9. Not Qualified. 14 15 M/s. CENTURION REMEDIES PVT. LTD. ,Vadodara (Gujrat) Tab. Sod. Picosulphate 10mg/Tab. (Aluminium foil/Blister pack) 1 D33251 Qualified. (3.33mg + 3.75ml + 1.25ml) / 5ml Sod. Picosulphate + Milk of Magnesia + Liquid Paraffin (Liquid) 2 D33252 Qualified. Tab. Tapentadol (Aluminium 50mg /Tab foil/Blister pack) 3 D33253 Qualified. Tab. Allopurinol (Aluminium 100 mg/Tab foil/Blister pack) 4 D33048 Qualified. Each Kit contain ( 125 mg - 1 Tab./Cap. And 80 mg - 2 Tab./Cap.) 5 D33081 Tab./Cap. Aprepetant Qualified. Tab. Abiraterone (Aluminium 250 mg / Tab. foil/Blister pack) 6 D33209 Qualified. 8 Sl No. Name of the Item Specification Reason for Rejection Remarks 15 16 M/s. GLOBELA PHARMA PVT. LTD. ,Surat (Gujrat) Cap. Thalidomide (Aluminium 50mg/Cap. foil/Blister pack) 1 D33255 Qualified. Tab. Tamoxifen (Aluminium 20 mg/ Tab foil/Blister pack) 2 D33041 Qualified. Tab. Methotrexate (Aluminium 5 mg/Tab foil/Blister pack) 3 D33051 Qualified. Tab. Imatinib(Aluminium 400 mg/Tab foil/Blister pack) 4 D33076 Qualified. Tab Anastrozole (Aluminium 1 Mg Foil/Blister Pack) 5 D33080 Qualified. Tab. Bicalutamide (Aluminium 50mg/Tab Foil/Blister Pack) 6 D33085 Qualified. Tab. Capecitabine (Aluminium 500mg/ Tab Foil/Blister Pack) 7 D33091 Qualified. Tab. Dasatinib (Aluminium 50 mg/ Tab. Foil/Blister Pack) 8 D33100 Qualified. Tab. Erlotinib (Aluminium 150mg/ Tab foil/Blister pack) 9 D33116 Qualified. Tab. Gefitinib (Aluminium 250mg/ Tab foil/Blister pack) 10 D33127 Qualified. Cap. Lenalidomide (Aluminium 10mg/ Cap foil/Blister pack) 11 D33132 Qualified. Tab. Letrozole (Aluminium 2.5mg/ Tab foil/Blister pack) 12 D33135 Qualified. Cap. Temozolamide (Aluminium 100mg/ Cap foil/Blister pack) 13 D33170 Qualified. Cap. Temozolamide (Aluminium 20mg / Cap foil/Blister pack) 14 D33171 Qualified. Cap. Temozolamide (Aluminium 250mg/ Cap foil/Blister pack) 15 D33172 Qualified. Cap. Thalidomide (Aluminium 100mg / Cap foil/Blister pack) 16 D33174 Qualified. Tab. Abiraterone (Aluminium 250 mg / Tab. foil/Blister pack) 17 D33209 Qualified. 9 Sl No. Name of the Item Specification Reason for Rejection Remarks 16 17 M/s. UNITED BIOTECH PVT LTD ,New Delhi (Delhi) 1 D33002 Inj. Cyclophosphamide 200mg/Vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 2 D33004 Inj. Cyclophosphamide 1gm/Vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 3 D33015 Inj. Doxorubicin HCl 2 mg / ml Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 4 D33017 Inj. Vincristine Sulphate 1mg / ml Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 5 D33023 Inj. Cisplatin 10 mg/Vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 6 D33024 Inj. Cisplatin 50 mg / vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 7 D33029 Inj. Mesna 200 mg/(Vial/Amp.) Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 8 D33054 Inj. Doxorubicin HCl 2mg/ ml Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 9 D33055 Inj. Carboplatin 150MG 10 mg / ml Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 10 D33056 Inj. Carboplatin 450MG 10 mg / ml Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 11 D33058 Inj. 5 Fluorouracil 500 mg / 10ml Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 12 D33059 Inj. Epirubicin 10mg / Vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 13 D33060 Inj. Epirubicin 50mg / Vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 14 D33064 Inj. Daunorubicin 20mg/vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. Inj. Etoposide (with diluents in 100mg/Vial plastic container) 15 D33071 Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. Inj. Gemciatbine (with diluents in 200mg/vial plastic container) 16 D33072 Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. Inj. Gemciatbine (with diluents in 1gm/vial plastic container) 17 D33073 Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. Tab Anastrozole (Aluminium 1 Mg Foil/Blister Pack) 18 D33080 Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. Each Kit contain ( 125 mg - 1 Tab./Cap. And 80 mg - 2 Tab./Cap.) 19 D33081 Tab./Cap. Aprepetant Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 20 D33087 Inj. Bortezomib 2mg / Vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 21 D33097 Inj. Cytarabine (with diluents) 100mg / vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 10 Sl No. Name of the Item Specification Reason for Rejection Remarks 22 D33098 Inj. Cytarabine (with diluents) 1GM / VIAL Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. Inj. Arabinocide / Cytarabine 500mg / Vial (with diluents) 23 D33099 Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 24 D33136 Inj. Leucovorin Calcium 50mg/vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 25 D33152 Inj. Oxaliplatin 50 mg / Vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 26 D33153 Inj. Oxaliplatin 100 mg / Vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 27 D33161 Inj. Pemetrexed 100 mg / Vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 28 D33162 Inj. Pemetrexed 500 mg / Vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 29 D33211 inj. Irinotecan 100 mg Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 30 D33220 Inj. Liposomal Doxorubicin 20 mg /vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 31 D33227 Inj. Methotrexate 500mg / 20ml vial Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. Ifosfamide 1gm/vial + Mesna 200mg/2ml Amp. x 3 Amps. 32 D33246 Inj. Ifosfamide with Mesna Turnover details for the financial year 2023-24 not uploaded as per clause No. 5.2.5. Not Qualified. 17 18 M/s. VENUS REMEDIES LTD. ,Panchkula (Haryana) 1 D33055 Inj. Carboplatin 150MG 10 mg / ml Qualified. 2 D33056 Inj. Carboplatin 450MG 10 mg / ml Qualified. 3 D33152 Inj. Oxaliplatin 50 mg / Vial Qualified. 4 D33153 Inj. Oxaliplatin 100 mg / Vial Qualified. 18 19 M/s. ZYDUS LIFESCIENCES LTD ,Ahmedabad (Gujarat) Cap. Palbociclib (Aluminium 125mg/Cap. foil/Blister pack) 1 D33249 Qualified. Tab. Eltrombopag Olamine 25 mg/Tab (Aluminium foil/Blister pack) 2 D16040 No WHO GMP as per clause No. 5.2.2. Not Qualified. Tab Anastrozole (Aluminium 1 Mg Foil/Blister Pack) 3 D33080 Qualified. 4 D33123 Inj. Filgrastim peg 6mg/ PFS Qualified. Inj. Trastuzumab (with diluets in 440mg one kit pack) 5 D33177 Qualified. Inj. Bevacizumab (with diluents in 25mg/ml plastic container) 100mg 6 D33214 Qualified. Inj. Bevacizumab (with diluents in 25mg / ml plastic container) 400mg 7 D33215 Qualified. Inj. Trastuzumab (with diluets) in 150mg/vial one pack 8 D33224 Qualified. 11 Sl No. Name of the Item Specification Reason for Rejection Remarks 19 20 M/s. HETERO HEALTHCARE LTD. ,Hyderabad Cap. Palbociclib (Aluminium 125mg/Cap. foil/Blister pack) 1 D33249 No Market Standing as per clause No. 5.2.9. Not Qualified. Cap. Thalidomide (Aluminium 50mg/Cap. foil/Blister pack) 2 D33255 Qualified. Tab. Tamoxifen (Aluminium 10 mg/ Tab. foil/Blister pack) 3 D33040 Qualified. Tab. Tamoxifen (Aluminium 20 mg/ Tab foil/Blister pack) 4 D33041 Qualified. 5 D33055 Inj. Carboplatin 150MG 10 mg / ml No Market Standing and Non Conviction certificate not submitted as per clause No. 5.2.9. & 5.2.10. respectively. Not Qualified. 6 D33056 Inj. Carboplatin 450MG 10 mg / ml No Market Standing and Non Conviction certificate not submitted as per clause No. 5.2.9. & 5.2.10. respectively. Not Qualified. Tab./Cap. Imatinib (Aluminium 100 mg/Tab./Cap foil/Blister pack) 7 D33075 Qualified. Tab. Imatinib(Aluminium 400 mg/Tab foil/Blister pack) 8 D33076 Qualified. Tab Anastrozole (Aluminium 1 Mg Foil/Blister Pack) 9 D33080 Qualified. Each Kit contain ( 125 mg - 1 Tab./Cap. And 80 mg - 2 Tab./Cap.) 10 D33081 Tab./Cap. Aprepetant Qualified. Tab. Bicalutamide (Aluminium 50mg/Tab Foil/Blister Pack) 11 D33085 Qualified. Tab. Capecitabine (Aluminium 500mg/ Tab Foil/Blister Pack) 12 D33091 Qualified. Tab. Dasatinib (Aluminium 50 mg/ Tab. Foil/Blister Pack) 13 D33100 Qualified. Tab. Erlotinib (Aluminium 150mg/ Tab foil/Blister pack) 14 D33116 Qualified. Tab. Gefitinib (Aluminium 250mg/ Tab foil/Blister pack) 15 D33127 Qualified. Cap. Lenalidomide (Aluminium 10mg/ Cap foil/Blister pack) 16 D33132 Qualified. Cap. Lenalidomide (Aluminium 5mg/ Cap foil/Blister pack) 17 D33134 Qualified. Tab. Letrozole (Aluminium 2.5mg/ Tab foil/Blister pack) 18 D33135 Qualified. Tab./Cap. Nilotinib (Aluminium 200 mg/Tab./Cap foil/Blister pack) 19 D33150 No Market Standing as per clause No. 5.2.9. Not Qualified. Tab. Pazopanib (Aluminium 200mg/ Tab foil/Blister pack) 20 D33160 Qualified. 21 D33164 Inj. Rituximab 100 mg / Vial Qualified. 22 D33165 Inj. Rituximab 500 mg / Vial Qualified. Tab. Sorafenib (Aluminium 200mg/ Tab foil/Blister pack) 23 D33167 Qualified. Cap. Sunitinib (Aluminium 12.5mg / Cap foil/Blister pack) 24 D33168 Qualified. Cap. Sunitinib (Aluminium 25mg/ Cap foil/Blister pack) 25 D33169 Qualified. Cap. Temozolamide (Aluminium 100mg/ Cap foil/Blister pack) 26 D33170 Qualified. Cap. Temozolamide (Aluminium 20mg / Cap foil/Blister pack) 27 D33171 Qualified. Cap. Temozolamide (Aluminium 250mg/ Cap foil/Blister pack) 28 D33172 Qualified. Cap. Thalidomide (Aluminium 100mg / Cap foil/Blister pack) 29 D33174 Qualified. Inj. Trastuzumab (with diluets in 440mg one kit pack) 30 D33177 Qualified. 12 Sl No. Name of the Item Specification Reason for Rejection Remarks Tab. Lapatinib (Aluminium 250mg/Tab foil/Blister pack) 31 D33208 Qualified. Tab. Abiraterone (Aluminium 250 mg / Tab. foil/Blister pack) 32 D33209 Qualified. Inj. Trastuzumab (with diluets) in 150mg/vial one pack 33 D33224 Qualified. Cap. Enzalutamide (Aluminium 40mg/Cap. foil/Blister pack) 34 D33244 Qualified. Cap. Lenvatinib (Aluminium 4mg/Cap. foil/Blister pack) 35 D33248 Qualified. 20 21 M/s. SAMARTH LIFE SCIENCES PVT. LTD. ,Mumbai (Maharashtra) Tab. Imatinib(Aluminium 400 mg/Tab foil/Blister pack) 1 D33076 Qualified. Tab Anastrozole (Aluminium 1 Mg Foil/Blister Pack) 2 D33080 Qualified. Tab. Bicalutamide (Aluminium 50mg/Tab Foil/Blister Pack) 3 D33085 Qualified. 4 D33087 Inj. Bortezomib 2mg / Vial Qualified. Tab. Capecitabine (Aluminium 500mg/ Tab Foil/Blister Pack) 5 D33091 Qualified. Tab. Dasatinib (Aluminium 50 mg/ Tab. Foil/Blister Pack) 6 D33100 Qualified. 7 D33107 Inj. Docetaxel (with diluents) 20mg / Vial Qualified. 8 D33108 Inj. Docetaxel (with diluents) 80mg / Vial Qualified. 9 D33109 Inj. Docetaxel (with diluents) 120 mg / Vial Qualified. Tab. Gefitinib (Aluminium 250mg/ Tab foil/Blister pack) 10 D33127 Qualified. Tab. Letrozole (Aluminium 2.5mg/ Tab foil/Blister pack) 11 D33135 Qualified. 12 D33136 Inj. Leucovorin Calcium 50mg/vial Qualified. 13 D33152 Inj. Oxaliplatin 50 mg / Vial Qualified. 14 D33153 Inj. Oxaliplatin 100 mg / Vial Qualified. 15 D33161 Inj. Pemetrexed 100 mg / Vial Qualified. 16 D33162 Inj. Pemetrexed 500 mg / Vial Qualified. Tab. Sorafenib (Aluminium 200mg/ Tab foil/Blister pack) 17 D33167 Qualified. Cap. Sunitinib (Aluminium 12.5mg / Cap foil/Blister pack) 18 D33168 Qualified. Cap. Sunitinib (Aluminium 25mg/ Cap foil/Blister pack) 19 D33169 Qualified. Cap. Temozolamide (Aluminium 100mg/ Cap foil/Blister pack) 20 D33170 Qualified. Cap. Temozolamide (Aluminium 250mg/ Cap foil/Blister pack) 21 D33172 Qualified. 22 D33181 Inj. Zoledronic Acid 4 mg / Vial Qualified. Tab. Lapatinib (Aluminium 250mg/Tab foil/Blister pack) 23 D33208 Qualified. Tab. Abiraterone (Aluminium 250 mg / Tab. foil/Blister pack) 24 D33209 Qualified. 21 22 M/s. GLENMARK PHARMACEUTICALS LTD. ,Mumbai Each Kit contain ( 125 mg - 1 Tab./Cap. And 80 mg - 2 Tab./Cap.) 1 D33081 Tab./Cap. Aprepetant Qualified. Tab. Abiraterone (Aluminium 250 mg / Tab. foil/Blister pack) 2 D33209 Qualified. 13 Sl No. Name of the Item Specification Reason for Rejection Remarks 22 23 M/s. DR. REDDYS LABORATORIES LTD ,Ranga Reddy (Telangana) Cap. Palbociclib (Aluminium 125mg/Cap. foil/Blister pack) 1 D33249 No Market Standing as per clause No. 5.2.9. Not Qualified. 2 D33029 Inj. Mesna 200 mg/(Vial/Amp.) No WHO GMP certificate as per clause No. 5.2.2. Not Qualified. Tab. Imatinib(Aluminium 400 mg/Tab foil/Blister pack) 3 D33076 No Market Standing as per clause No. 5.2.9. Not Qualified. Tab. Dasatinib (Aluminium 50 mg/ Tab. Foil/Blister Pack) 4 D33100 No Market Standing as per clause No. 5.2.9. Not Qualified. Cap. Lenalidomide (Aluminium 10mg/ Cap foil/Blister pack) 5 D33132 No Market Standing as per clause No. 5.2.9. Not Qualified. Cap. Lenalidomide (Aluminium 5mg/ Cap foil/Blister pack) 6 D33134 No Market Standing as per clause No. 5.2.9. Not Qualified. 7 D33164 Inj. Rituximab 100 mg / Vial Qualified. 8 D33165 Inj. Rituximab 500 mg / Vial Qualified. 9 D33195 Inj. Azacitidine (with diluents) 100 mg/Vial No WHO GMP & No Market Standing as per clause No. 5.2.2. & 5.2.9 respectively. Not Qualified. Inj. Bevacizumab (with diluents in 25mg/ml plastic container) 100mg 10 D33214 Qualified. Inj. Bevacizumab (with diluents in 25mg / ml plastic container) 400mg 11 D33215 Qualified. 14 Sl No. Name of the Item Specification Reason for Rejection Remarks 23 24 M/s. NAPROD LIFE SCIENCES PVT. LTD. ,Mumbai Inj. L-Asperginase (Powder form) 10,000 IU / Vial (with diluents in plastic container) 1 D33053 Qualified. 2 D33055 Inj. Carboplatin 150MG 10 mg / ml Qualified. 3 D33056 Inj. Carboplatin 450MG 10 mg / ml Qualified. 4 D33060 Inj. Epirubicin 50mg / Vial Qualified. Inj. Bleomycin (with diluents in 15 IU/vial plastic container) 5 D33069 Qualified. Inj. Gemciatbine (with diluents in 200mg/vial plastic container) 6 D33072 Qualified. Inj. Gemciatbine (with diluents in 1gm/vial plastic container) 7 D33073 Qualified. Tab. Imatinib(Aluminium 400 mg/Tab foil/Blister pack) 8 D33076 Qualified. Inj. Paclitaxel (with transfusion set 260mg /Vial (PVC and DEHP free Administration set,EVA administration set with 0.2 micro meter filter for drugs and solutions incompatible with PVC, A 9 D33079 Qualified. Tab Anastrozole (Aluminium 1 Mg Foil/Blister Pack) 10 D33080 Qualified. 11 D33083 Inj. Bendamustine 100mg Qualified. Tab. Bicalutamide (Aluminium 50mg/Tab Foil/Blister Pack) 12 D33085 No Mfg. License, No WHO GMP Certificate, No Market Standing and Non Conviction certificate not submitted as per clause No. 5.2.1. , 5.2.2., 5.2.9. & 5.2.10. respectively. Not Qualified. 13 D33087 Inj. Bortezomib 2mg / Vial Qualified. Tab. Capecitabine (Aluminium 500mg/ Tab Foil/Blister Pack) 14 D33091 Qualified. 15 D33107 Inj. Docetaxel (with diluents) 20mg / Vial Qualified. 16 D33108 Inj. Docetaxel (with diluents) 80mg / Vial Qualified. 17 D33109 Inj. Docetaxel (with diluents) 120 mg / Vial Qualified. Cap. Lenalidomide (Aluminium 10mg/ Cap foil/Blister pack) 18 D33132 Qualified. Inj. Paclitaxel (with transfusion set 100 mg / Vial (PVC and DEHP free Administration set,EVA administration set with 0.2 micro meter filter for drugs and solutions incompatible with PVC, A 19 D33156 Qualified. 20 D33161 Inj. Pemetrexed 100 mg / Vial Qualified. 21 D33162 Inj. Pemetrexed 500 mg / Vial Qualified. 15 Sl No. Name of the Item Specification Reason for Rejection Remarks 24 25 M/s. RELIANCE LIFE SCIENCES PVT LTD ,Navi Mumbai (Maharashtra) Tab./Cap. Imatinib (Aluminium 100 mg/Tab./Cap foil/Blister pack) 1 D33075 No Mfg. License, No WHO GMP Certificate, No Market Standing and Non Conviction certificate not submitted as per clause No. 5.2.1. , 5.2.2., 5.2.9. & 5.2.10. respectively. Not Qualified. Tab. Imatinib(Aluminium 400 mg/Tab foil/Blister pack) 2 D33076 No Mfg. License, No WHO GMP Certificate, No Market Standing and Non Conviction certificate not submitted as per clause No. 5.2.1. , 5.2.2., 5.2.9. & 5.2.10. respectively. Not Qualified. Tab. Capecitabine (Aluminium 500mg/ Tab Foil/Blister Pack) 3 D33091 Qualified. Tab. Dasatinib (Aluminium 50 mg/ Tab. Foil/Blister Pack) 4 D33100 No Market Standing as per clause No. 5.2.9. Not Qualified. Tab. Erlotinib (Aluminium 150mg/ Tab foil/Blister pack) 5 D33116 Qualified. 6 D33122 Inj. Filgrastim 300mcg/ Vial Qualified. 7 D33123 Inj. Filgrastim peg 6mg/ PFS Qualified. Cap. Lenalidomide (Aluminium 10mg/ Cap foil/Blister pack) 8 D33132 Qualified. Cap. Lenalidomide (Aluminium 5mg/ Cap foil/Blister pack) 9 D33134 Qualified. Tab./Cap. Nilotinib (Aluminium 200 mg/Tab./Cap foil/Blister pack) 10 D33150 No Mfg. License, No WHO GMP Certificate, No Market Standing and Non Conviction certificate not submitted as per clause No. 5.2.1. , 5.2.2., 5.2.9. & 5.2.10. respectively. Not Qualified. Tab. Pazopanib (Aluminium 200mg/ Tab foil/Blister pack) 11 D33160 No Mfg. License, No WHO GMP Certificate, No Market Standing and Non Conviction certificate not submitted as per clause No. 5.2.1. , 5.2.2., 5.2.9. & 5.2.10. respectively. Not Qualified. 12 D33161 Inj. Pemetrexed 100 mg / Vial Qualified. 13 D33162 Inj. Pemetrexed 500 mg / Vial Qualified. 14 D33164 Inj. Rituximab 100 mg / Vial Qualified. 15 D33165 Inj. Rituximab 500 mg / Vial Qualified. Tab. Sorafenib (Aluminium 200mg/ Tab foil/Blister pack) 16 D33167 No Mfg. License, No WHO GMP Certificate, No Market Standing and Non Conviction certificate not submitted as per clause No. 5.2.1. , 5.2.2., 5.2.9. & 5.2.10. respectively. Not Qualified. Cap. Sunitinib (Aluminium 12.5mg / Cap foil/Blister pack) 17 D33168 No Mfg. License, No WHO GMP Certificate, No Market Standing and Non Conviction certificate not submitted as per clause No. 5.2.1. , 5.2.2., 5.2.9. & 5.2.10. respectively. Not Qualified. Cap. Sunitinib (Aluminium 25mg/ Cap foil/Blister pack) 18 D33169 No Mfg. License, No WHO GMP Certificate, No Market Standing and Non Conviction certificate not submitted as per clause No. 5.2.1. , 5.2.2., 5.2.9. & 5.2.10. respectively. Not Qualified. Cap. Temozolamide (Aluminium 100mg/ Cap foil/Blister pack) 19 D33170 Qualified. Cap. Temozolamide (Aluminium 20mg / Cap foil/Blister pack) 20 D33171 No Mfg. License, No WHO GMP Certificate, No Market Standing and Non Conviction certificate not submitted as per clause No. 5.2.1. , 5.2.2., 5.2.9. & 5.2.10. respectively. Not Qualified. Cap. Temozolamide (Aluminium 250mg/ Cap foil/Blister pack) 21 D33172 Qualified. Inj. Trastuzumab (with diluets in 440mg one kit pack) 22 D33177 Qualified. 16 Sl No. Name of the Item Specification Reason for Rejection Remarks 23 D33195 Inj. Azacitidine (with diluents) 100 mg/Vial No Market Standing as per clause No. 5.2.9. Not Qualified. 24 D33210 Inj. Denosumab 120mg Qualified. Tab. Dasatinib (Aluminium 20 mg/ Tab. Foil/Blister Pack) 25 D33213 No Market Standing as per clause No. 5.2.9. Not Qualified. Inj. Bevacizumab (with diluents in 25mg/ml plastic container) 100mg 26 D33214 Qualified. Inj. Bevacizumab (with diluents in 25mg / ml plastic container) 400mg 27 D33215 Qualified. Inj. Trastuzumab (with diluets) in 150mg/vial one pack 28 D33224 Qualified. 25 26 M/s. MEDIPOL PHARMACEUTICALS INDIA PVT. LTD. ,Noida (UP) (3.33mg + 3.75ml + 1.25ml) / 5ml Sod. Picosulphate + Milk of Magnesia + Liquid Paraffin (Liquid) 1 D33252 Qualified. 2 D33216 Benzydamine HCl Mouth wash 0.15% w/v Qualified. Chlorhexidine Gluconate solution 0.2% w/v (mouth wash) 3 D33219 No Market Standing as per clause No. 5.2.9. Not Qualified. 26 27 M/s. EISAI PHARMACEUTICALS INDIA PVT. LTD. ,Mumbai Cap. Lenvatinib (Aluminium 4mg/Cap. foil/Blister pack) 1 D33248 Qualified. 27 28 M/s. ENZENE BIOSCIENCES LTD. ,Pune Inj. Bevacizumab (with diluents in 25mg/ml plastic container) 100mg 1 D33214 No WHO GMP & No Market Standing as per clause No. 5.2.2. & 5.2.9 respectively. Not Qualified. Inj. Bevacizumab (with diluents in 25mg / ml plastic container) 400mg 2 D33215 No WHO GMP & No Market Standing as per clause No. 5.2.2. & 5.2.9 respectively. Not Qualified. 3 D33217 Inj. Cetuximab 5mg / ml No WHO GMP & No Market Standing as per clause No. 5.2.2. & 5.2.9 respectively. Not Qualified. 28 29 M/s. GENNOVA BIOPHARMACEUTICALS LTD ,Pune (Maharashtra) 1 D33122 Inj. Filgrastim 300mcg/ Vial Qualified. 2 D33123 Inj. Filgrastim peg 6mg/ PFS Qualified.
