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Page 1: S.No API Name - Home - Heterodrugs México API Name Status Contact : Dr. B.P.S. Reddy Chairman & Managing Director Phone : +91-40-2381 4635 bpsreddy@heterodrugs.com A.V. Narasa Reddy
Page 2: S.No API Name - Home - Heterodrugs México API Name Status Contact : Dr. B.P.S. Reddy Chairman & Managing Director Phone : +91-40-2381 4635 bpsreddy@heterodrugs.com A.V. Narasa Reddy

StatusAPI NameS.No

List of

Drug Master Files

1. Acyclovir USDMF/EDMF2. Adefovir Dipivoxil USDMF/EDMF3. Alfuzosin Hydrochloride USDMF/EDMF4. Amlodipine Besylate USDMF/EDMF5. Apixaban USDMF/EDMF6. Aripiprazole USDMF/EDMF7. Atomoxetine Hydrochloride USDMF/EDMF8. Atorvastatin Calcium Amorphous & Crystalline USDMF/EDMF9. Atovaquone USDMF/EDMF10. Bosentan Hydrate USDMF11. Bupropion Hydrochloride USDMF/EDMF12. Candesartan Cilexetil USDMF/EDMF13. Celecoxib Form III USDMF/EDMF14. Cilazapril EDMF15. Cinacalcet Hydrochloride USDMF/EDMF16. Citalopram Hydrobromide USDMF/EDMF17. Clopidogrel Bisulphate Form I & Form II USDMF/EDMF18. Cyclobenzaprine Hydrochloride USDMF/EDMF19. Dabigatran Etexilate Mesylate USDMF/EDMF20. Dapagliflozin USDMF/EDMF21. Darifenacin Hydrobromide USDMF/EDMF22. Desloratadine USDMF/EDMF23. Donepezil Hydrochloride Form I & Form III USDMF/EDMF24. Divalproex Sodium USDMF/EDMF25. Dorzolamide Hydrochloride USDMF/EDMF26. Doxazosin Mesylate EDMF27. Droxidopa USDMF/EDMF28. Duloxetine Hydrochloride USDMF/EDMF29. Dutasteride USDMF/EDMF30. Eletriptan Hydrobromide a Form USDMF/EDMF31. Eltrombopag Olamine USDMF/EDMF32. Empagliflozin USDMF/EDMF33. Entacapone Form A USDMF/EDMF34. Eprosartan Mesylate USDMF/EDMF35. Escitalopram Oxalate USDMF/EDMF36. Eslicarbazepine USDMF/EDMF37. Esomeprazole Mg Dihydrate/ Trihydrate USDMF/EDMF38. Esomeprazole Sodium USDMF/EDMF39. Etoricoxib Form I USDMF/EDMF40. Ezetimibe USDMF/EDMF41. Famciclovir USDMF/EDMF42. Febuxostat USDMF/EDMF43. Fenofibrate USDMF44. Fesoterodine Fumarate USDMF

None of the products will be supplied to countries where they could be in conflict with existing patents. However, the final responsibility lies exclusively with the buyer.

Page 3: S.No API Name - Home - Heterodrugs México API Name Status Contact : Dr. B.P.S. Reddy Chairman & Managing Director Phone : +91-40-2381 4635 bpsreddy@heterodrugs.com A.V. Narasa Reddy

StatusAPI NameS.No45. Fexofenadine Hydrochloride Form I USDMF/EDMF46. Finasteride Form I USDMF/EDMF47. Fingolimod Hydrochloride USDMF/EDMF48. Fosinopril Sodium USDMF/EDMF49. Gabapentin USDMF/EDMF50. Ganciclovir USDMF/EDMF51. Glimepiride USDMF/EDMF52. Hydralazine Hydrochloride USDMF/EDMF53. Irbesartan Form A USDMF/EDMF54. Lacosamide Form I USDMF/EDMF55. Lansoprazole USDMF/EDMF56. Lercanidipine Hydrochloride EDMF57. Levetiracetam USDMF/EDMF58. Levofloxacin USDMF/EDMF59. Levomilnacipran Hydrochloride USDMF/EDMF60. Lisinopril USDMF/EDMF61. Loratadine EDMF62. Losartan Potassium Form I USDMF/EDMF63. Lurasidone Hydrochloride USDMF/EDMF64. Macitentan USDMF/EDMF65. Milnacipran Hydrochloride USDMF/EDMF66. Montelukast Sodium USDMF/EDMF67. Moxifloxacin Hydrochloride Monohydrate/Anhydrous USDMF/EDMF68. Memantine Hydrochloride Form I USDMF/EDMF69. Metaxalone USDMF70. Nabumetone USDMF/EDMF71. Nebivolol Hydrochloride USDMF/EDMF72. Olanzapine Form I USDMF/EDMF73. Olmesartan Medoxomil USDMF/EDMF74. Omeprazole Form A & Form B USDMF/EDMF75. Omeprazole Magnesium USDMF/EDMF76. Oseltamivir Phosphate Form A USDMF/EDMF77. Pantoprazole Sodium USDMF/EDMF78. Perindopril Erbumine USDMF/EDMF79. Pioglitazone Hydrochloride USDMF/EDMF80. Pitavastatin Calcium Form H1 USDMF/EDMF81. Pramipexole di Hydrochloride USDMF/EDMF82. Prasugrel Hydrochloride Form B USDMF/EDMF83. Pregabalin USDMF/EDMF84. Proguanil Hydrochloride USDMF/EDMF85. Quetiapine Fumarate USDMF/EDMF86. Rabeprazole Sodium USDMF/EDMF87. Ramipril USDMF/EDMF88. Raloxifene Hydrochloride USDMF/EDMF

None of the products will be supplied to countries where they could be in conflict with existing patents. However, the final responsibility lies exclusively with the buyer.

Page 4: S.No API Name - Home - Heterodrugs México API Name Status Contact : Dr. B.P.S. Reddy Chairman & Managing Director Phone : +91-40-2381 4635 bpsreddy@heterodrugs.com A.V. Narasa Reddy

StatusAPI NameS.No89. Riluzole USDMF/EDMF90. Risedronate sodium USDMF/EDMF91. Rizatriptan Benzoate USDMF/EDMF92. Rosuvastatin Calcium USDMF/EDMF93. Roflumilast USDMF/EDMF94. Rufinamide USDMF/EDMF95. Saxagliptin USDMF/EDMF96. Sertraline Hydrochloride Form I & Form II USDMF/EDMF97. Sevelamer Hydrochloride & Carbonate USDMF/EDMF98. Sildenafil Citrate USDMF/EDMF99. Simvastatin USDMF/EDMF100. Solifenacin Succinate USDMF/EDMF101. Silodosin a Form/b Form USDMF/EDMF102. Telmisartan USDMF/EDMF103. Terbinafine Hydrochloride USDMF/EDMF104. Tetrabenazine USDMF/EDMF105. Tolvaptan USDMF/EDMF106. Tolterodine Tartrate Form I USDMF/EDMF107. Topiramate USDMF/EDMF108. Torsemide USDMF/EDMF109. Valacyclovir Hydrochloride USDMF/EDMF110. Valganciclovir USDMF/EDMF111. Valsartan USDMF/EDMF112. Voriconazole Form I USDMF/EDMF113. Vortioxetine HBr USDMF/EDMF114. Zolmitriptan USDMF/EDMF115. Zonisamide USDMF/EDMF116. Ziprasidone Hydrochloride USDMF/EDMF

ANTIRETROVIRALS1. Abacavir Sulphate USDMF/EDMF2. Atazanavir Sulphate USDMF/EDMF3. Darunavir Amorphous & Ethanolate USDMF/EDMF4. Didanosine USDMF/EDMF5. Efavirenz Form I USDMF/EDMF6. Emtricitabine USDMF/EDMF7. Entecavir USDMF/EDMF8. Etravirine Form I USDMF/EDMF9. Lamivudine Form I & Form II USDMF/EDMF10. Lopinavir Form I & Amorphous USDMF/EDMF11. Maraviroc Form B & Amorphous USDMF/EDMF12. Nevirapine Form I USDMF/EDMF13. Raltegravir Potassium Form I & Amorphous USDMF/EDMF14. Ritonavir Form I & Amorphous Premix USDMF/EDMF

List of

Drug Master Files

None of the products will be supplied to countries where they could be in conflict with existing patents. However, the final responsibility lies exclusively with the buyer.

Page 5: S.No API Name - Home - Heterodrugs México API Name Status Contact : Dr. B.P.S. Reddy Chairman & Managing Director Phone : +91-40-2381 4635 bpsreddy@heterodrugs.com A.V. Narasa Reddy

StatusAPI NameS.No15. Saquinavir Mesylate USDMF/EDMF16. Stavudine USDMF/EDMF17. Tenofovir Disoproxil Fumarate USDMF/EDMF18. Zidovudine USDMF/EDMF19. Fosamprenavir Calcium Technical Package

ANTINEOPLASTICS1. Abiraterone Acetate USDMF/EDMF2. Anastrozole USDMF/EDMF3. Aprepitant USDMF/EDMF4. Azacitidine USDMF/EDMF5. Bendamustine Hydrochloride USDMF/EDMF6. Bexarotene USDMF/EDMF7. Bicalutamide USDMF/EDMF8. Bortezomib USDMF/EDMF9. Cabazitaxel Form C USDMF10. Capecitabine USDMF/EDMF11. Carboplatin USDMF/EDMF12. Cisplatin USDMF/EDMF13. Cyclophosphamide USDMF/EDMF14. Docetaxel USDMF/EDMF15. Erlotinib Hydrochloride Form A USDMF/EDMF16. Fosaprepitant Dimeglumine USDMF/EDMF17. Gefitinib USDMF/EDMF18. Gemcitabine Hydrochloride USDMF/EDMF19. Imatinib Mesylate Amorphous/ a Form/�b Form USDMF/EDMF20. Irinotecan Hydrochloride USDMF/EDMF21. Lapatinib Ditosylate USDMF/EDMF22. Lenalidomide Form H/Form B USDMF/EDMF23. Letrozole USDMF/EDMF24. Nilotinib Hydrochloride Dihydrate Form A USDMF/EDMF25. Oxaliplatin USDMF/EDMF26. Paclitaxel USDMF/EDMF27. Pazopanib Hydrochloride USDMF/EDMF28. Pemetrexed Disodium 2.5 Hydrate/7.0 Hydrate USDMF/EDMF29. Plerixafor USDMF/EDMF30. Pralatrexate Form A USDMF/EDMF31. Sorafenib Tosylate Form III USDMF/EDMF32. Sunitinib Malate Form I/Base USDMF/EDMF33. Temozolomide Form III USDMF/EDMF34. Thalidomide USDMF/EDMF35. Zoledronic Acid Form I USDMF/EDMF

None of the products will be supplied to countries where they could be in conflict with existing patents. However, the final responsibility lies exclusively with the buyer.

Page 6: S.No API Name - Home - Heterodrugs México API Name Status Contact : Dr. B.P.S. Reddy Chairman & Managing Director Phone : +91-40-2381 4635 bpsreddy@heterodrugs.com A.V. Narasa Reddy

StatusAPI Name

36. Afatinib Dimaleate USDMF37. Axitinib Form IV USDMF38. Crizotinib/ Premix USDMF/EDMF39. Enzalutamide USDMF40. Ibrutinib USDMF/EDMF41. Melphalan Hydrochloride USDMF/EDMF42. Regorafenib Form I USDMF/EDMF43. Pomalidomide Form A USDMF44. Tamoxifen Citrate USDMF45. Trametinib Dimethylsulfoxide USDMF46. Bosutinib Technical Package47. Cabozantinib Technical Package48. Carfilzomib Technical Package49. Ceritinib Technical Package50. Idelalisib Technical Package51. Nintedanib Technical Package52. Olaparib Technical Package53. Palbociclib Technical Package54. Vemurafenib Technical Package55. Vismodegib Technical Package

HEPATITIS-C, CHRONIC - ANTIVIRALS 1. Daclatasvir Di Hydrochloride USDMF2. Ledipasvir USDMF3. Sofosbuvir USDMF4. Velpatasvir Technical Package

1. Alogliptin Benzoate Form A USDMF/EDMF2. Avanafil USDMF3. Azilsartan Kamedoxomil Form I USDMF/EDMF4. Canagliflozin USDMF5. Cilnidipine USDMF6. Clobazam USDMF7. Cobicistat USDMF/EDMF8. Dimethyl Fumarate USDMF9. Elvitegravir Form III USDMF10. Linagliptin/Premix USDMF11. Mirabegron a Form/b Form USDMF12. Ospemifene USDMF13. Pirfenidone USDMF14. Posaconazole Form III USDMF/EDMF

List of

New Products

List of New Products

ANTINEOPLASTICS - New Products

S.No

None of the products will be supplied to countries where they could be in conflict with existing patents. However, the final responsibility lies exclusively with the buyer.

Page 7: S.No API Name - Home - Heterodrugs México API Name Status Contact : Dr. B.P.S. Reddy Chairman & Managing Director Phone : +91-40-2381 4635 bpsreddy@heterodrugs.com A.V. Narasa Reddy

StatusAPI NameS.No

Contact :Dr. B.P.S. ReddyChairman & Managing DirectorPhone : +91-40-2381 [email protected]

A.V. Narasa ReddyExecutive Director Phone : +91-40-2371 [email protected]

Vamsi Krishna BandiDirector Phone : +91-40-2370 [email protected]

15. Rilpivirine Hydrochloride USDMF/EDMF16. Sitagliptin Phosphate/Hydrochloride USDMF/EDMF17. Tadalafil Form I USDMF18. Tenofovir Alafinamide USDMF19. Teriflunomide USDMF20. Ticagrelor Form II USDMF/EDMF21. Vildagliptin EDMF22. Acotiamide Hydrochloride Trihydrate Technical Package23. Apremilast Technical Package24. Azithromycin Dihydrate Technical Package25. Bedaquiline Fumarate Technical Package26. Brexiprazole Technical Package27. Brivaracetam Technical Package28. Colesevelam Hydrochloride Technical Package29. Congrelor Tetrasodium Technical Package30. Dalfampridine/ Fampridine Technical Package31. Dexlansoprazole Technical Package32. Edoxaban Tosilate Technical Package33. Gemigliptin Technical Package34. Ivabradine Hydrochloride Premix Technical Package35. Ivacaftor Technical Package36. Lesinurad Technical Package37. Lomitapide Mesylate Technical Package38. Obeticholic Acid Technical Package39. Omarigliptin Technical Package40. Oxcarbazepine Technical Package41. Ponatinib Hydrochloride Technical Package42. Rupatadine Fumarate Technical Package43. Sacubitril + Valsartan. Technical Package44. Selexipag Technical Package45. Suvorexant Technical Package46. Teneligliptin Hydrobromide Technical Package47. Tofacitinib Citrate Technical Package48. Trelagliptin Succinate Technical Package49. Vorapaxar Technical Package

None of the products will be supplied to countries where they could be in conflict with existing patents. However, the final responsibility lies exclusively with the buyer.

Page 8: S.No API Name - Home - Heterodrugs México API Name Status Contact : Dr. B.P.S. Reddy Chairman & Managing Director Phone : +91-40-2381 4635 bpsreddy@heterodrugs.com A.V. Narasa Reddy

Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad – 500 018. Telangana, INDIAPhone: +91 40 23704923/24/25 Fax: +91 40 23813359, 23704926Email: [email protected]