EU Market
Finished Dosage Forms
Improving public health with exceptional FDF dossiers
Flavine Europe GmbH is located in Munich, Germany and offers high-quality finished dosage form dossiers for the EU market. Efforts are underway to expand FDF dossier offering to the USA and other regulated global markets.
Available FDF:
- Oral, Solid
- Oral, Liquid
- Injection
- Inhalation
- Topical
- Ophthalmic
Therapeutic Indication:
- Anti-infection
- Anti-diabetic
- Anti-fungal
- Anti-inflammatory
- Cardiovascular Health
- Carnitine Deficiency
- Central Nervous System
- Chronic Iron Overload
- Chronic Obstructive
- Chronic Obstructive
- Pulmonary Disorder (COPD)
- Dermatology
- Diagnostics
- Food Supplement
- Insomnia
- Insomnia
- Ophthalmology
- SARS-CoV‑2 / COVID-19
- Smoking Cessation
- Urology
- Vitamin D Deficiencies
FDF Dossier List
EU Market
| PRODUCT | ADMINISTRATION ROUTE / USAGE | DOSAGE / STRENGTH | THERAPEUTIC APPLICATION |
|---|---|---|---|
| Abiraterone Acetate | Tablet | 250mg, 500mg | Oncology |
| Amlodipine & Telmisartan | Tablet | 5mg/40mg, 5mg/80mg, 10mg/40mg, 10mg/80mg | Cardiovascular System |
| Apixaban | Tablet | 2.5mg, 5mg | Cardiovascular System |
| Aripiprazole | Tablet | 5mg, 10mg | Central Nervous System |
| Aripiprazole | ODT | 10mg, 15mg | Central Nervous System |
| Atorvastatin | Tablet | 10mg, 20mg, 40mg, 80mg | Cardiovascular System |
| Azithromycin | Tablet | 250mg, 500mg | Antibiotic |
| Azithromycin | Powder (suspension) | 200mg/5ml | Antibiotic |
| Calcifediol | Capsule (soft) | 266µg | Other |
| Calcifediol | Oral drops | 0.15mg/ml, 1.5mg/ml | Other |
| Carbimazole | Tablet | 5mg, 10mg, 15mg, 20mg | Endocrinology |
| Carbocysteine | Stick pack | 750mg/7.5ml | Respiratory System |
| Ceftazidime | Vials | 1gr/vial 3ml | Analgesics / Anti-infectives / Anti-inflammatories |
| Ceftriaxone Sodium | Vials | 1g & 1% lidocaine/3.5ml or WFI/10ml | Analgesics / Anti-infectives / Anti-inflammatories |
| Cefuroxime Sodium | Vials | 750mg; 1.5g e 2.0g | Analgesics / Anti-infectives / Anti-inflammatories |
| Cholecalciferol (D3) | Capsule (soft) | 800IU, 1.000IU, 3.2000IU, 20.000IU, 25.000IU, 50.000IU | Other |
| Cholecalciferol (D3) | Liquid oral drops or oral solution | 10.000IU/ml — 10ml (multidose); 25.000IU/2.5ml, 50.000IU/2.5ml (single dose) | Other |
| Cholecalciferol (D3) & Calcium | Chewable tablet | 400IU/500mg, 800IU/1g | Other |
| Clarithromycin | Tablet | 250mg, 500mg | Antibiotic |
| Clopidogrel | Tablet | 75mg | Cardiovascular system |
| Cyclosporine | Eye drop emulsion | 0.1% | Ophtalmology |
| Decitabine | Powder for injection | 50mg/vial | Oncology |
| Deferasirox | Tablet | 90mg, 180mg, 360mg | Other |
| Dexametasone & Netilmicin Sulfate | Eye drops | 5ML bottle 0.1% & 0.3% or 15/20 Monodose preservative free 0.3% | Ophthalmology |
| Dimethyl Fumarate | Delayed released capsule | 120mg, 240mg | Central Nervous System |
| Dutasteride | Capsule (soft) | 0.5mg | Urology |
| Eltrombopag Olamine | Tablet | 12.5mg, 25mg, 50mg, 75mg | Cardiovascular System |
| Empagliflozin | Tablet | 10mg, 25mg | Antidiabetics |
| Empagliflozin & Metformin | Tablet | 5mg/850mg, 5mg/1000mg, 12.5mg/850 mg, 12.5mg/1000mg | Antidiabetics |
| Entacapone | Tablet | 200mg | Central Nervous System |
| Escitalopram | Tablet | 5mg, 10mg, 15mg, 20mg | Central Nervous System |
| Fampridine | Tablet | 10mg | Central Nervous System |
| Fesoterodine Fumarate | ER tablets | 4mg, 8mg | Urology |
| Fingolimod | Tablet | 0.5mg | Immunosuppressant |
| Fluticasone Furoate | Nasal spray | 27.5mcg/dose | Respiratory |
| Fusidic Acid & Chitosan* | Cream | 20mg/g | Dermatology |
| Fusidic Acid & Chitosan* | Gel | 0.02 | Dermatology |
| Isavuconazole | Capsule | 186mg, 372mg | Antifungal |
| Isavuconazole | Powder for injection | 200mg/vial | Antifungal |
| Isotretinoin | Capsule (soft) | 5mg, 10mg, 20mg, 40mg | Dermatology/Diabetology |
| L‑Carnitine | Stick pack | 1g, 2g | Carnitine Deficiency |
| LCE (Levodopa, Carbidopa, Entacapone) | Tablet | 50/12.5/200mg, 75/18.75/200mg | Central Nervous System |
| Levocabastine | Eye drops | 0.05% ophthalmic suspension | Ophthalmology |
| Levosimendan | IV injection | 2.5mg/ml, 5ml | Cardiovascular System |
| Levothyroxine Sodium | Tablets | 25mcg, 50mcg,75mcg, 88mcg, 100mcg,112mcg, 125mcg, 137mcg, 150mcg, 175mcg, 200mcg, 300mcg | Endocrinology |
| Linagliptin | Tablet | 5mg | Antidiabetics |
| Linagliptin & Metfromin | Tablet | 2.5mg/500mg, 2.5mg/850mg, 2.5mg/1000mg | Antidiabetics |
| Melatonin | Oral solution | 5mg/5ml, 100ml and 200 ml | Other |
| Memantine | IR Tablets | 5mg, 10mg, 15mg, 20mg | Central Nervous System |
| Metformin | XR tablet | 500mg, 750mg, 1g | Antidiabetics |
| Micafungin | Powder for injection | 50mg/vial, 100mg/vial | Antifungal |
| Moxifloxacin HCl | Tablet | 400mg | Analgesics / Anti-infectives / Anti-inflammatories |
| Naproxen & Esomeprazole | Modified release tablet | 500mg/20mg | Analgesics / Anti-infectives / Anti-inflammatories |
| Netilmicin Sulfate | Eye drops | 5ML bottle 0.3% or 15/20 Monodose preservative free 0.3% | Ophthalmology |
| Nitrofurantoin | Macrocrystal capsules | 100mg | Urology |
| Olanzapine | ODT | 5mg, 10mg, 15mg, 20mg | Central Nervous System |
| Olmesartan | Tablet | 10mg, 20mg,40mg | Cardiovascular System |
| Oseltamivir | Hard capsules | 30mg, 45mg, 75mg | Antiviral |
| Palbociclib | Tablet | 75mg | Oncology |
| Paracetamol & Codeine | Effervescent tablet | 500mg & 30mg | Analgesics / Anti-infectives / Anti-inflammatories |
| Parecoxib | Powder for injection | 40mg/vial | Analgesics / Anti-infectives / Anti-inflammatories |
| Pomalidomide | Capsule | 1mg, 2mg, 3mg, 4mg | Oncology |
| Posaconazole | Injection (i.v.) | 18mg/ml (300mg per 16.7 ml) | Antifungal |
| Posaconazole | DR tablet (gastro-resistant) | 100mg | Antifungal |
| Quetiapine | Tablet | 25mg, 100mg, 150mg, 200mg, 300mg | Central Nervous System |
| Regorafenib | Tablet | 40mg | Oncology |
| Rivaroxaban | Tablet | 2.5mg, 10mg, 15mg, 20mg | Cardiovascular System |
| Roflumilast | Tablet | 500mcg | Respiratory |
| Rosuvastatin Calcium | Tablet | 5mg, 10mg, 20mg, 40mg | Cardiovascular System |
| SARS-CoV2 Antibody Detection Kit | ELISA kit | 80 tests/box | IgM and IgG detection |
| SARS-CoV2 Rapid IgG Detection | Fast serological test | 25 tests/box | IgG detection |
| Selexipag | Tablet | 200mcg, 400mcg, 600mcg, 800mcg, 1000mcg, 1200mcg, 1400mcg, 1600mcg | Cardiovascular System |
| Sildenafil | Tablet | 25mg, 50mg, 100mg | Urology |
| Sitagliptin & Metformin | Tablet | 50/850mg, 50/1000mg | Antidiabetics |
| Solifenacin | Tablet | 10mg | Urology |
| Sugammadex | Injection (i.v.) | 200mg/2ml, 500mg/5ml | Central Nervous System |
| Tadalafil | Tablet | 2.5mg, 5mg, 10mg, 20mg | Urology |
| Tadalafil | Capsule (soft) | 5mg, 10mg, 20mg | Urology |
| Teriflunomide | Tablet | 14mg | Central Nervous System |
| Ticagrelor | Film tablets | 60mg, 90mg | Cardiovascular System |
| Tigecycline | Vials (lyophilized powder) | 50mg/vial | Analgesics / Anti-infectives / Anti-inflammatories |
| Tofacitinib | ER tablets | 5mg, 10mg Tablet, 11mg | Other |
| Varenicline Tartrate | Tablet | 0.5mg, 1mg | Other |
For information about FDF dossiers availability and development status please contact us.
FLAVINE EUROPE GMBH
Wehrlestrasse 12
81679 Munich, Germany
Phone: [+49] 89–939-967–0
Fax: [+49] 89–939-967–16
E‑Mail: Flavine-europe@flavine.eu