Carboplatin | EU GMP | EU Region | Dossier Ready - eCTD | Ready |
Gemcitabine | EU GMP | EU Region | Dossier Ready - eCTD | Ready |
Methotrexate | EU GMP | EU Region | Dossier Ready - eCTD | Ready |
Irinotecan | EU GMP | EU Region | Dossier Ready - eCTD | Ready |
Pemetrexed | EU GMP | EU Region | Dossier Ready - eCTD | Ready |
Paclitaxel | EU GMP | EU Region | Dossier Ready - eCTD | Ready |
Oxaliplatin | EU GMP | EU Region | Dossier Ready - eCTD | Ready |
NAB Paclitaxel | EU GMP | EU Region | Dossier Ready - eCTD | Ready |
Tacrolimus | EU GMP | EU Region | Final Validation underway | In Pipeline - 7 months to commercialization ready |
Mycophenolate Mofetil | EU GMP | EU Region | Final Validation underway | In Pipeline - 7 months to commercialization ready |
Mycophenolate Acid | EU GMP | EU Region | Final Validation underway | In Pipeline - 7 months to commercialization ready |
Everolimus | EU GMP | EU Region | Final Validation underway | In Pipeline - 7 months to commercialization ready |
Dabigatran | EU GMP | EU Region | Final Validation underway | In Pipeline - 7 months to commercialization ready |
Budesonide | EU GMP | EU Region | Final Validation underway | In Pipeline - 7 months to commercialization ready |
Heparin Bovine | SFDA | Saudi | Under approval | In Pipeline - 3 months to final approval |
Enoxaparin | SFDA | Saudi | Under approval | In Pipeline - 3 months to final approval |
Letrozole | EU GMP | EU Region | Final dossier ready for submission | 7 months to PT CoPP, filing in Jan 2024 in PT |
Imatinib | EU GMP | EU Region | Final dossier ready for submission | 7 months to PT CoPP, filing in Jan 2024 in PT |
Nilotinib | EU GMP | EU Region | BA/BE Study underway | 10 months to market |
Glimepiride & its combination | EU GMP | EU Region | BA/BE Study underway | 10 months to market & 3 months to filing |