PRODUCT PORTFOLIO
Our product dossiers are compiled in accordance with EMA, TGA, US FDA, and PIC/s requirements and provided in CTD format.
Edge offers a comprehensive list of products available to our customers through a variety of flexible and customized B2B business models including License & Supply Agreements, Exclusive Distribution Agreements, Asset Swaps, Risk Share Agreements, Co-development contributions, Direct Acquisitions, or any other practical commercial proposal.
Our strategic portfolio selection is designed according to different market requirements, patent restrictions, and opportunities therefore availability is subject to review on a product by product basis. Please click here to contact us if you wish to talk about any specific products, collaborations, acquisitions, or just ideas on developing new opportunities together.
Explore Our Portfolio
| MOLECULE | DOSAGE FORM | PACK TYPE | STRENGTH | DOSSIER FORMAT | MA COUNTRY | MA STATUS | GMP STATUS |
|---|---|---|---|---|---|---|---|
| Abiraterone | Tablet | Bottle | 250mg; 500mg | ANDA | US | Submitted | EU/FDA |
| Acyclovir | Tablet | Bottle | 400mg; 800mg | ANDA | US | Registered | FDA/MHRA |
| Acyclovir | Capsule | Bottle | 200mg | ANDA | US | Submitted | FDA/MHRA |
| Acyclovir | Solution for injection | Vial | 500mg/10ml, 1g/20ml |
CTD/ANDA | EU/US | Submission Q2.20 | EU/FDA |
| Afatinib | Tablet | Bottle | 40mg | ANDA | US | Submitted | EU/FDA |
| Atracurium Besylate | Powder for injection | Vial | 10mg/5ml; 20mg/10ml; 200mg/20ml |
CTD/ANDA | EU/US | Submission Q2.20 | EU/FDA |
| Azacitidine | Powder for injection | Vial | 100mg | CTD/ANDA | EU/US | Submission Q3.20 | EU/FDA |
| Azithromycin | Powder for injection | Vial | 500mg | CTD/ANDA | EU/US | Registered | EU/FDA |
| Azithromycin | Tablet | Blister/Bottle | 250mg; 500mg; 600mg |
ANDA | US | Registered | FDA |
| Beclomethasone dipropionate | Nasal Spray | Spray Bottle | 50; 100µg 200doses | CTD | TGA | Submitted | TGA |
| Bivalirudin | Powder for injection | Vial | 250mg | CTD/ANDA | EU/US | Registered | EU/FDA |
| Bortezomib | Powder for injection | Vial | 3.5mg | CTD/ANDA | EU/US | Registered | EU/FDA |
| Budesonide | Nasal Spray | Spray Bottle | 32μg 120 doses/50μg;100 μg 200 doses |
CTD | TGA | Submitted | TGA |
| Bupropion HCl | XL Tablet | Bottle | 150mg; 300mg | ANDA | US | Registered | FDA |
| Buspirone Hydrochloride | Tablet | Bottle | 5mg; 10mg; 15mg; 30mg |
ANDA | US | Registered | FDA/MHRA |
| Calcium folinate | Powder for injection | Vial | 50mg; 100mg; 200mg; 350mg; 500mg |
CTD/ANDA | EU/US | Submission Q1.20 | EU/FDA |
| Calcium levofolinate | Powder for injection | Vial | 50mg; 175mg | CTD/ANDA | EU/US | Submission Q2.20 | EU/FDA |
| Carboplatin | Solution for injection | Vial | 50mg/5ml; 150mg/15ml; 450mg/45ml; 600mg/60ml |
CTD/ANDA | EU/US | Submission Q3.20 | EU/FDA |
| Carfilzomib | Powder for injection | Vial | 60mg | ANDA | US | Registered | EU/FDA |
| Cefazolin | Powder for injection | Vial | 500mg; 1g | CTD | EU/AU | Registered | EU/FDA |
| Cefepime | Powder for injection | Vial | 500mg; 1g; 2 g | CTD | EU/AU | Registered | EU/FDA |
| Ceftazidime | Powder for injection | Vial | 1g; 2g | CTD | EU/AU | Registered | EU/FDA |
| Ceftriaxone | Powder for injection | Vial | 500mg; 1g; 2 g | CTD | EU/AU | Registered | EU/FDA |
| Cefuroxime | Powder for injection | Vial | 250mg; 750mg; 1.5 gm |
CTD | EU/AU | Registered | EU/FDA |
| Celecoxib | Capsule | Bottle | 50mg; 100mg; 200mg |
ANDA | US | Registered | FDA |
| Celecoxib | Capsule | Bottle | 50mg; 100mg; 200mg; 400mg |
ANDA | US | Submitted | FDA/MHRA |
| Cinacalcet | Tablet | Bottle | 30mg | ANDA | US | Submitted | EU/FDA |
| Ciprofloxacin | Tablet | Bottle | 250mg; 500mg | ANDA | US | Registered | FDA/MHRA |
| Datomycin | Powder for injection | Vial | 350mg; 500mg | CTD/ANDA | EU/US | Submission Q2.20 | EU/FDA |
| Decitabine | Solution for injection | Vial | 50mg | ANDA | US | Submission Q1.20 | Pending |
| Decitabine | Powder for injection | Vial | 50mg | CTD/ANDA | EU/US | Submission Q2.20 | EU/FDA |
| Decitabine | Powder for injection | Vial | 50mg | ANDA | US | Submitted | EU/FDA |
| Desloratadine | Tablet | Blister | 2.5mg; 5mg | CTD | EU | Registered | EU |
| Dexmedetomidine HCl | Solution for injection | Ampoule | 0.2mg/2ml | CTD/ANDA | EU/US | Submission TBD | Pending |
| Dobutamine | Solution for injection | Vial | 250mg/20ml; 500mg/40ml |
CTD/ANDA | EU/US | Submission Q3.20 | EU/FDA |
| Doxycycline | Powder for injection | Vial | 100mg; 200mg | CTD/ANDA | EU/US | Submission Q3.20 | EU/FDA |
| Duloxetine Hydrochloride | DR Capsule | Bottle | 20mg; 30mg; 60mg | ANDA | US | Registered | FDA |
| Entecavir | Tablet | Bottle | 0.5mg; 1.0mg | ANDA | US | Registered | FDA |
| Eptifibatide | Solution for injection | Vial | 20mg/10ml; 75mg/100ml | CTD/ANDA | EU/US | Registered | EU/FDA |
| Esomeprazole | Powder for injection | Vial | 20mg; 40mg | CTD/ANDA | EU/US | Submission Q1.20 | EU/FDA |
| Felodipine | ER Tablet | Bottle | 2.5mg; 5mg; 10mg | ANDA | US | Registered | FDA/MHRA |
| Fosaprepitant | Powder for injection | Vial | 150mg | ANDA | US | Submitted | EU/FDA |
| Fulevstrant | Pre-Filled syringe | PFS | 250mg/5ml | ANDA | US | Submission Q1.20 | Pending |
| Gabapentin | Tablet | Bottle | 600mg; 800mg | ANDA | US | Registered | FDA |
| Gabapentin | Capsule | Bottle | 100mg; 300mg; 400mg |
ANDA | US | Registered | FDA |
| Ganciclovir | Powder for injection | Vial | 500mg | CTD/ANDA | EU/US | Registered | EU/FDA |
| Gemcitabine | Powder for injection | Vial | 200mg/1000mg | ANDA | US | Registered | FDA |
| Granisetron | Solution for injection | Ampoule | 1mg; 3mg | CTD | EU/AU | Registered | EU/FDA |
| Icatibant | Pre-Filled syringe | PFS | 3ml (10mg/ml) | ANDA | US | Submitted | Pending |
| Iopamidol | Solution for injection | Vial | 41%; 51%; 76% | CTD/ANDA | EU/US | Submission Q3.20 | EU/FDA |
| Irinotecan HCl | Solution for injection | Vial | 40mg/2ml; 100mg/5ml;300mg/15ml; 500mg/25ml |
CTD | EU/TGA | Registered | EU/FDA |
| Levetiracetam | Solution for injection | Vial | 500mg/5ml | CTD/ANDA | EU/US | Registered | EU/FDA |
| Levofloxacin | Tablet | Blister/Bottle | 250mg; 500mg | CTD | EU | Submitted | EU |
| Lincomycin | Solution for injection | Vial | 300mg/ml | CTD/ANDA | EU/US | Submission Q1.20 | EU/FDA |
| Lisinopril | Tablet | Bottle | 2.5mg; 5mg; 10mg | ANDA | US | Submitted | FDA/MHRA |
| Lisinopril | Tablet | Bottle | 20mg; 30mg; 40mg | ANDA | US | Submitted | FDA/MHRA |
| Metformin | ER Tablet | Bottle | 500mg; 750mg | ANDA | US | Registered | FDA |
| Metformin | Tablet | Bottle | 500mg; 850mg; 1000mg |
ANDA | US | Registered | FDA |
| Micafungin Sodium | Powder for injection | Vial | 50mg; 100mg | CTD/ANDA | EU/US | Submitted | Pending |
| Ondansetron | Solution for injection | Ampoule | 4mg; 8mg | CTD/ANDA | EU/US/AU | Registered | EU/FDA |
| Oxaliplatin | Powder for injection | Vial | 50mg/10ml; 100mg/20ml; 200mg/40ml |
CTD | TGA | Registered | EU/FDA |
| Oxcarbazepine | Tablet | Blister/Bottle | 150mg; 300mg; 600mg |
CTD/ANDA | EU | Submission Q4.20 | Pending |
| Palonosetron | Solution for injection | Ampoule | 0.25mg/5ml | CTD | EU | Registered | EU/FDA |
| Pantoprazole | Powder for injection | Vial | 40mg | CTD/ANDA | EU/US/AU | Registered | EU/FDA |
| Parecoxib sodium | Powder for injection | Vial | 40mg | CTD | AU | Submitted | Pending |
| Pemetrexed Sodium | Powder for injection | Vial | 100mg; 500mg | CTD/ANDA | EU/US/TGA | Registered | EU/FDA |
| Quetiapine | SR Tablet | Bottle | 50mg; 150mg; 200mg; 300mg; 400mg |
ANDA | US | Submitted | EU/FDA |
| Revlimid | Capsules | Bottle | 2.5mg; 5mg; 10mg; 15mg; 25mg |
ANDA | US | Submitted | EU/FDA |
| Sodium Nitroprusside | Solution for injection | Vial | 25mg/ml | ANDA | US | Registered | EU/FDA |
| Solifenacin Succinate | Tablet | Bottle | 5mg; 10mg | CTD/ANDA | EU/US | Registered | EU/FDA |
| Sugammadex Sodium | Solution for injection | Vial | 200mg/2ml; 500mg/5ml | ANDA | US | Submission Q1.20 | EU/FDA |
| Sugammadex Sodium | Solution for injection | Vial | 200mg/2ml; 500mg/5ml | CTD/ANDA | EU/US | Submission Q3.20 | EU/FDA |
| Tadalafil | Tablet | Blister/Bottle | 5mg; 10mg; 20mg | CTD/ANDA | EU/US | Registered | EU/FDA |
| Tazobactam/Piperacillin | Powder for injection | Vial | 4.5g | CTD | EU/AU | Registered | EU/FDA |
| Terlipressin | Solution for injection | Vial | 1mg/8.5ml | CTD | EU | Submission Q1.20 | EU/FDA |
| Tobramycin Sulfate | Powder for injection | Vial | 1.2g | CTD/ANDA | EU/US | Submission Q2.20 | EU/FDA |
| Tramadol | Tablet | Bottle | 50mg | ANDA | US | Registered | FDA |
| Trimebutine maleate | Tablet | Blister/Bottle | 0.1g; 0.2g | CTD/ANDA | EU | Submission Q4.20 | Pending |
| Tropisetron | Solution for injection | Ampoule | 5mg/5ml | CTD | EU/AU | Registered | EU/FDA |
| Valacyclovir | Tablet | Bottle | 500mg; 1000mg | ANDA | US | Registered | FDA/MHRA |
| Venlafaxine | Tablet | Bottle | 25mg; 37.5mg; 50mg; 75mg; 100mg |
ANDA | US | Registered | FDA |
| Voriconazole | Powder for injection | Vial | 200mg | CTD/ANDA | EU/US | Registered | EU/FDA |
Availability of products is subject to patent restrictions in countries where applicable patents are in effect and excludes any licensing initiatives into the Republic of South Africa until further notice.