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DOSSIER LIST Your trusted B2B partner
AVAILABLE DOSSIERS
PHARMACEUTICAL REFERENCE THERAPEUTIC CLASS / LACTOSE CPP
PRODUCT NAME STRENGTH ZONE IV
FORM PRODUCT MAIN INDICATION FREE FEASIBILITY
ALIMENTARY TRACT & METABOLISM
Powder
Peptic ulcer and
Esomeprazole for solution Nexium /
1 40 mg gastro-oesophageal N/A
(sodium) for infusion AstraZeneca
reflux disease
or injection
Trajenta / Blood glucose
Film-coated IVa: b
2 Linagliptin*CA 5 mg Boehringer lowering drug
tablets IVb: on-going
Ingelheim (DPP4-i)
Powder Peptic ulcer and
Losec /
3 Omeprazole for solution 40 mg gastro-oesophageal N/A
AstraZeneca
for infusion reflux disease
4 Orlistat OTC Hard capsules 60 mg Alli / GSK Anti-obesity N/A
5 Orlistat Hard capsules 120 mg Xenical / Roche Anti-obesity N/A
Pantoprazole Powder Peptic ulcer and
Pantozol /
6 (sodium for solution 40 mg gastro-oesophageal N/A
Altana
sesquihydrate) for injection reflux disease
25 mg Blood glucose
Sitagliptin Film-coated IVa: b
7 50 mg Januvia / Merck lowering drug
(hydrochloride) tablets IVb: on-going
100 mg (DPP4-i)
Sitagliptin 50/850 mg Blood glucose
(hydrochloride)/ Film-coated Janumet /
8 50/1000 lowering drugs, N/A
tablets Merck
Metformin mg combination
ANTI-INFECTIVES FOR SYSTEMIC USE
200 mg
Antiviral
9 Aciclovir Tablets 400 mg Zovirax / GSK N/A
for systemic use
800 mg
Powder
Klacid IV / Antibacterial
10 Clarithromycin for solution 500 mg N/A
Abbott for systemic use
for infusion
BLOOD & BLOOD FORMING ORGANS
Eliquis /
Film-coated 2.5 mg Antithrombotic IVa: b
11 Apixaban Bristol-Myers
tablets 5 mg agent IVb: on-going
Squibb
2.5 mg
Film-coated 10 mg Antithrombotic IVa: b
12 Rivaroxaban* CA
Xarelto / Bayer
tablets 15 mg agent IVb: on-going
20 mg
Ticagrelor* (5) Film-coated 60 mg Brilique / Antithrombotic IVa: b
13
tablets 90 mg AstraZeneca agent IVb: availablePHARMACEUTICAL REFERENCE THERAPEUTIC CLASS / LACTOSE CPP
PRODUCT NAME STRENGTH ZONE IV
FORM PRODUCT MAIN INDICATION FREE FEASIBILITY
CARDIOVASCULAR SYSTEM
Norvasc
Amlodipine 5/10 mg Calcium channel
(Amlodipine) +
(besilate)/ Film-coated 10/10 mg blocker & lipid
14 Sortis N/A
Atorvastatin tablets 5/20 mg modifying agent
(Atorvastatin) /
(calcium) 10/20 mg combination
Pfizer
Calcium channel
5/80 mg blocker
Amlodipine (maleate)/ Film-coated Exforge / IVa: b
15 5/160 mg & angiotensin-II
Valsartan(1) tablets Novartis IVb: available
10/160 mg antagonist
combination
12.5 mg (2)
Esidrex /
16 Hydrochlorothiazide* Tablets 25 mg Diuretic N/A
Novartis
50 mg
Solution 1 mg/ml Betaloc / IVa: on-going
17 Metoprolol tartrate Beta blocking agent
for injection (5ml) AstraZeneca IVb: a
Tritace
5/5 mg (Ramipril) / ACE inhibitor &
Ramipril /
5/10 mg Sanofi & calcium channel
18 Amlodipine Hard capsules N/A
10/5 mg Norvasc blocker
(besilate)
10/10 mg (Amlodipine) / combination
Pfizer
5 mg
Rosuvastatin Film-coated 10 mg Crestor / Lipid modifying
19 N/A
(calcium) tablets 20 mg AstraZeneca agent
40 mg
Angiotensin-II
40/10 mg
Twynsta / antagonist &
Telmisartan/ 40/5 mg IVa: b
20 Tablets Boehringer calcium channel
Amlodipine(5) 80/10 mg IVb: on-going
Ingelheim blocker
80/5 mg
combination
DERMATOLOGICALS
1 mg/g IVa: available
Fenistil /
21 Dimetindene OTC (3) Gel (20g, 30g, Topical antipruritic
Novartis IVb: a
50g)
GENITO-URINARY SYSTEM & SEX HORMONES
2.5 mg
Tadalafil* Film-coated 5 mg Cialis / Erectile IVa: b
22
tablets 10 mg Eli Lilly dysfunction IVb: available
20 mg
IMMUNOMODULATING
2.5 mg
5 mg
7.5 mg Revlimid /
23 Lenalidomide Capsules 10 mg Celgene Immunosupressant IVa: b
15 mg IVb: on-going
20 mg
25 mgAVAILABLE DOSSIERS
PHARMACEUTICAL REFERENCE THERAPEUTIC CLASS / LACTOSE CPP
PRODUCT NAME STRENGTH ZONE IV
FORM PRODUCT MAIN INDICATION FREE FEASIBILITY
NERVOUS SYSTEM
Relapsing forms of
Dimethyl Gastro-resistant 120 mg Tecfidera / IVa: b
24 Multiple Sclerosis
fumarateCA hard capsules(4) 240 mg Biogen Idec IVb: on-going
(MS)
Nurofen Ultima/ Analgesic
Ibuprofen/ Film-coated 200 / 500
25 Reckitt and antipyretic N/A
Paracetamol tablets mg
Benckiser combination
Memantine Film-coated 10 mg Ebixa / IVa: available
26 Anti-dementia
hydrochloride tablets 20 mg Lundbeck IVb: a
Metamizole Film-coated Novalgin / Analgesic
27 500 mg N/A
sodium tablets Sanofi Aventis and antipyretic
25 mg
100 mg
Film-coated Seroquel / IVa: available
28 Quetiapine (fumarate) 150 mg Antipsychotic
tablets AstraZeneca IVb: available
200 mg
300 mg
RESPIRATORY SYSTEM
1 mg/ml +
50 mg/ml
Xylometazoline Nasal
Nasal spray (10 ml) Nasic / IVa: b
29 (hydrochloride)/ descongestant
solution 0.5 mg/ml + Cassella-med IVb: available(6)
Dexpanthenol(3) OTC & cicatrizant
50 mg/ml
(10 ml)
* Polpharma Group API
CA
Dossier suitable for Canadian Market
(1)
Pending dossier update (new API Valsartan source required)
(2)
No CPP feasibility for Hydrochlorothiazide 50 mg
(3)
Dossier availability subject to some restriction
(4)
Delayed release capsules, as per CA standard Terms
(5)
BEQ study against Canadian reference product available
(6)
Only for higher Strength: 1 mg/ml + 50 mg/ml (10 ml)
IVa: b = Not available, can be extrapolated from IVb
IVb: a = Not available, can be extrapolated from IVa
IVb: a = Not available and cannot be extrapolated from IVa
N/A = Not Available Data
Last update:
Dossier ready to file
April 2021DOSSIERS UNDER DEVELOPMENT
THERAPEUTIC
PRODUCT NAME PHARMACEUTICAL STRENGTH REFERENCE CLASS / MAIN DOSSIER
FORM PRODUCT INDICATION AVAILABILITY
ALIMENTARY TRACT & METABOLISM
Blood glucose
5 mg Forxiga / Astra
1 Dapagliflozin* Film-coated tablets lowering drug 2021 Q2
10 mg Zeneca
(SGLT2-i)
Blood glucose
5/850 mg Xigduo / Astra
2 Dapagliflozin* / Metformin Film-coated tablets lowering drug 2022 Q1
5/1000 mg Zeneca
(SGLT2-i)
Jardiance / Blood glucose
10 mg
3 Empagliflozin* Film-coated tablets Boehringer lowering drug 2021 Q4
25 mg
Ingelheim (SGLT2-i)
5mg/500mg
5mg/850mg
Synjardy / Blood glucose
Empagliflozin* / 5mg/1000 mg Early
4 Film-coated tablets Boehringer lowering drug
Metformin 12.5mg/500mg stage
Ingelheim (SGLT2-i)
12.5mg/850mg
12.5mg/1000mg
2.5/500 mg Jentadueto / Blood glucose
5 Linagliptin* / Metformin Film-coated tablets 2.5/850 mg Boehringer lowering drugs 2022 Q1
2.5/1000 mg Ingelheim combination
CARDIOVASCULAR SYSTEM
5 mg
Xanef (Vasotec,
6 Enalapril Tablets 10 mg ACE inhibitor 2021 Q2
Renitec) / MSD
20 mg
5 mg Beta blocking 2021 Q4
7 Nebivolol Tablets Nebilet / Menarini
10 mg agent
Neprilysin inhibitor
24mg / 26 mg
Sacubitril / & angiotensin II
8 Film-coated tablets 49mg / 51mg Entresto / Novartis 2023 Q4
Valsartan receptor blocker
97mg / 103mg
combination
DERMATOLOGICALS
Anti-acne
Adapalene / Early
9 Gel 0,1% + 2,5% Epiduo / Galderma combination for
Benzoyl peroxide stage
topical use
RESPIRATORY
Inhalation powder, Seebri Breezhaler /
10 Glycopyrronium 44 mcg Anticholinergic 2022 Q2
hard capsules Novartis
Indacaterol / Inhalation powder, Ultibro Breezhaler /
11 85/43 mcg Anticholinergic 2022 Q4
Glycopyrronium hard capsules NovartisDOSSIERS UNDER DEVELOPMENT
THERAPEUTIC
PRODUCT NAME PHARMACEUTICAL STRENGTH REFERENCE CLASS / MAIN DOSSIER
FORM PRODUCT INDICATION AVAILABILITY
IMMUNOMODULATING
10mg Immunosupressant /
12 Apremilast* Film-coated tablets 20mg Otezla / Celgene Psoriasis & 2022 Q1
30mg psoriatic arthritis
5mg Immunosupressant / Early
13 Tofacitinib IR Film-coated tablets Xeljanz / Pfizer
10mg Rheumatoid arthritis stage
Prolonged-release Immunosupressant /
14 Tofacitinib SR 11mg Xeljanz / Pfizer Early stage
tablet Rheumatoid arthritis
NERVOUS SYSTEM
5mg
10mg Brintellix / H.
15 Vortioxetine Film-coated tablets Depressive disorder 2022 Q4
15mg Lundbeck A/S
20mg
VITAMINS & MINERALS
20.000 IU Treatment
Soft gelatin
16 Cholecalciferol (Vitamin D3) 50.000 IU -- of Vitamin D 2021 Q4
capsules
100.000 IU deficiency
* Polpharma Group API
For more information and updates regarding available dossiers and dossiers under development please contact Last update:
your assigned Sales Manager or our Commercial Department. Note: Products protected by valid patents are not
offered for sale in countries where the sale of such products constitutes patent infringement. Availability may be April 2021
restricted to certain markets or countries.Farmaprojects, your trusted B2B partner with more than 30 years of experience
in out-licensing business model, as a result of a strategic alliance with Polpharma,
offers an attractive portfolio with European supply.
European Dossiers +
Supply
OL-expertise
WE OFFER
Focus on the newest Cardiology trends, developing mono & combo products
Wide Oral Antidiabetics portfolio (Combinations & Plain)
Anti-obesity main Molecule (Orlistat)
Other key therapeutic groups: Antithrombotic, Nervous System and Respiratory drugs, among others
Lyophilized portfolio
Multidisciplinary Team Support:
Sales Marketing RA PM
QA/QC IP R&D
Combined efforts with Polpharma’s volumes, guarantees supply continuity
Technical team fully dedicated to secure on-time launches
2 API suppliers to reduce risks
Planning & Production Team
Dossier adjustment to different non-EU market requirements
Products tested for Zone IV territories
Flexibility of Business Model for selected markets
Early launch possibility (FTO)
Competitive COGS based on economy of scales
API manufactured internally
Dedicated Customer ServiceCONTACT
salesb2b@polpharma.com
www www.polpharma.pl
www.polpharmab2b.com
www.farmaprojects.es
Meet us on LinkedIn:
www.linkedin.com/company/polpharma-b2b
POLPHARMA GROUP
PHARMACEUTICAL WORKS
Pelplińska 19
83-200 Starogard Gdański
Poland
phone: +48 58 563 16 00
FARMAPROJECTS
POLPHARMA B2B STRATEGIC PARTNER
Carrer Provença 392, 6ª Planta
08025 Barcelona (Spain)
Phone: +34 93 508 05 00
Last update:
April 2021You can also read
