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:

Therapeutic Indication:

Click here to download Finished Dosage Form Dossier List:

FDF Dossier List 
EU Mar­ket
PRODUCTADMINISTRATION ROUTE
/ USAGE
DOSAGE / STRENGTHTHERAPEUTIC APPLICATION
Abi­raterone AcetateTablet250mg, 500mg Oncol­o­gy
Amlodip­ine & TelmisartanTablet5mg/40mg, 5mg/80mg, 10mg/40mg, 10mg/80mgCar­dio­vas­cu­lar System
Apix­a­banTablet2.5mg, 5mgCar­dio­vas­cu­lar System
Arip­ipra­zoleTablet5mg, 10mgCen­tral Ner­vous System
Arip­ipra­zoleODT10mg, 15mgCen­tral Ner­vous System
Ator­vas­tatinTablet10mg, 20mg, 40mg, 80mgCar­dio­vas­cu­lar System
AzithromycinTablet250mg, 500mg Antibi­ot­ic
AzithromycinPow­der (sus­pen­sion)200mg/5mlAntibi­ot­ic
Cal­cife­di­olCap­sule (soft)266µgOth­er
Cal­cife­di­olOral drops0.15mg/ml, 1.5mg/mlOth­er
Car­bima­zoleTablet5mg, 10mg, 15mg, 20mgEndocrinol­o­gy
Car­bo­cys­teineStick pack750mg/7.5mlRes­pi­ra­to­ry System
Cef­tazidimeVials1gr/vial 3mlAnal­gesics / Anti-infec­tives / Anti-inflammatories
Cef­tri­ax­one SodiumVials1g & 1% lidocaine/3.5ml or WFI/10mlAnal­gesics / Anti-infec­tives / Anti-inflammatories
Cefurox­ime SodiumVials750mg; 1.5g e 2.0gAnal­gesics / Anti-infec­tives / Anti-inflammatories
Chole­cal­cif­er­ol (D3)Cap­sule (soft)800IU, 1.000IU, 3.2000IU, 20.000IU, 25.000IU, 50.000IUOth­er
Chole­cal­cif­er­ol (D3)Liq­uid oral drops or oral solution10.000IU/ml — 10ml (mul­ti­dose); 25.000IU/2.5ml, 50.000IU/2.5ml (sin­gle dose)Oth­er
Chole­cal­cif­er­ol (D3) & CalciumChew­able tablet400IU/500mg, 800IU/1gOth­er
Clar­ithromycinTablet250mg, 500mg Antibi­ot­ic
Clopi­do­grelTablet75mgCar­dio­vas­cu­lar system
CyclosporineEye drop emulsion0.1%Oph­tal­mol­o­gy
DecitabinePow­der for injection50mg/vialOncol­o­gy
DeferasiroxTablet90mg, 180mg, 360mgOth­er
Dex­am­eta­sone & Netilmicin SulfateEye drops5ML bot­tle 0.1% & 0.3% or 15/20 Mon­o­dose preser­v­a­tive free 0.3%Oph­thal­mol­o­gy
Dimethyl FumarateDelayed released capsule120mg, 240mgCen­tral Ner­vous System
Dutas­terideCap­sule (soft)0.5mgUrol­o­gy
Eltrom­bopag OlamineTablet12.5mg, 25mg, 50mg, 75mgCar­dio­vas­cu­lar System
EmpagliflozinTablet10mg, 25mgAntidi­a­bet­ics
Empagliflozin & MetforminTablet5mg/850mg, 5mg/1000mg, 12.5mg/850 mg, 12.5mg/1000mgAntidi­a­bet­ics
Enta­caponeTablet200mgCen­tral Ner­vous System
Esc­i­talo­pramTablet5mg, 10mg, 15mg, 20mgCen­tral Ner­vous System
Fam­pri­dineTablet10mgCen­tral Ner­vous System
Fes­otero­dine FumarateER tablets4mg, 8mgUrol­o­gy
Fin­golimodTablet0.5mgImmuno­sup­pres­sant
Flu­ti­ca­s­one FuroateNasal spray27.5mcg/doseRes­pi­ra­to­ry
Fusidic Acid & Chitosan*Cream20mg/gDer­ma­tol­ogy
Fusidic Acid & Chitosan*Gel0.02Der­ma­tol­ogy
Isavu­cona­zoleCap­sule186mg, 372mgAnti­fun­gal
Isavu­cona­zolePow­der for injection200mg/vialAnti­fun­gal
IsotretinoinCap­sule (soft)5mg, 10mg, 20mg, 40mgDermatology/Diabetology
L‑CarnitineStick pack1g, 2gCar­ni­tine Deficiency
LCE (Lev­odopa, Car­bidopa, Entacapone)Tablet50/12.5/200mg, 75/18.75/200mgCen­tral Ner­vous System
Lev­o­cabas­tineEye drops0.05% oph­thalmic suspensionOph­thal­mol­o­gy
Lev­osi­men­danIV injec­tion2.5mg/ml, 5mlCar­dio­vas­cu­lar System
Levothy­rox­ine SodiumTablets25mcg, 50mcg,75mcg, 88mcg, 100mcg,112mcg, 125mcg, 137mcg, 150mcg, 175mcg, 200mcg, 300mcgEndocrinol­o­gy
LinagliptinTablet5mgAntidi­a­bet­ics
Linagliptin & MetfrominTablet2.5mg/500mg, 2.5mg/850mg, 2.5mg/1000mgAntidi­a­bet­ics
Mela­toninOral solu­tion5mg/5ml, 100ml and 200 mlOth­er
Meman­tineIR Tablets5mg, 10mg, 15mg, 20mgCen­tral Ner­vous System
Met­forminXR tablet500mg, 750mg, 1gAntidi­a­bet­ics
Mica­fun­ginPow­der for injection50mg/vial, 100mg/vialAnti­fun­gal
Mox­i­floxacin HClTablet400mgAnal­gesics / Anti-infec­tives / Anti-inflammatories
Naprox­en & EsomeprazoleMod­i­fied release tablet500mg/20mgAnal­gesics / Anti-infec­tives / Anti-inflammatories
Netilmicin Sul­fateEye drops5ML bot­tle 0.3% or 15/20 Monodose
preser­v­a­tive free 0.3%
Oph­thal­mol­o­gy
Nitro­fu­ran­toinMacro­crys­tal capsules100mgUrol­o­gy
Olan­za­p­ineODT5mg, 10mg, 15mg, 20mgCen­tral Ner­vous System
Olme­sar­tanTablet10mg, 20mg,40mgCar­dio­vas­cu­lar System
OseltamivirHard cap­sules30mg, 45mg, 75mgAntivi­ral
Pal­bo­ci­clibTablet75mgOncol­o­gy
Parac­eta­mol & CodeineEffer­ves­cent tablet500mg & 30mgAnal­gesics / Anti-infec­tives / Anti-inflammatories
Pare­cox­ibPow­der for injection40mg/vialAnal­gesics / Anti-infec­tives / Anti-inflammatories
Poma­lido­mideCap­sule1mg, 2mg, 3mg, 4mgOncol­o­gy
Posacona­zoleInjec­tion (i.v.)18mg/ml (300mg per 16.7 ml)Anti­fun­gal
Posacona­zoleDR tablet (gas­tro-resis­tant)100mgAnti­fun­gal
Que­ti­ap­ineTablet25mg, 100mg, 150mg, 200mg, 300mgCen­tral Ner­vous System
Rego­rafenibTablet40mgOncol­o­gy
Rivarox­a­banTablet2.5mg, 10mg, 15mg, 20mgCar­dio­vas­cu­lar System
Rof­lu­mi­lastTablet500mcgRes­pi­ra­to­ry
Rosu­vas­tatin CalciumTablet5mg, 10mg, 20mg, 40mgCar­dio­vas­cu­lar System
SARS-CoV2 Anti­body Detec­tion KitELISA kit80 tests/boxIgM and IgG detection
SARS-CoV2 Rapid IgG DetectionFast sero­log­i­cal test25 tests/boxIgG detec­tion
Selex­i­pagTablet200mcg, 400mcg, 600mcg, 800mcg, 1000mcg, 1200mcg, 1400mcg, 1600mcgCar­dio­vas­cu­lar System
Silde­nafilTablet25mg, 50mg, 100mgUrol­o­gy
Sitagliptin & MetforminTablet50/850mg, 50/1000mgAntidi­a­bet­ics
Solife­nacinTablet10mgUrol­o­gy
Sug­am­madexInjec­tion (i.v.)200mg/2ml, 500mg/5mlCen­tral Ner­vous System
TadalafilTablet2.5mg, 5mg, 10mg, 20mgUrol­o­gy
TadalafilCap­sule (soft)5mg, 10mg, 20mgUrol­o­gy
Ter­i­fluno­mideTablet14mgCen­tral Ner­vous System
Tica­grelorFilm tablets60mg, 90mgCar­dio­vas­cu­lar System
Tige­cy­clineVials (lyophilized powder)50mg/vialAnal­gesics / Anti-infec­tives / Anti-inflammatories
Tofac­i­tinibER tablets5mg, 10mg Tablet, 11mgOth­er
Vareni­cline TartrateTablet0.5mg, 1mgOth­er

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

Get in Touch

Disclaimers:

Some of the products listed are currently under development and therefore pertinent information may not be available at this time. Any product listed which is covered under current patents is available only for use reasonably related to the development and submission of information to the relevant Health Authorities to the extent permitted under applicable laws regulating the manufacture, use and sale of Finished Dosage Forms, Active Pharmaceutical Ingredients, and/or their intermediates.