Our Portfolio
Export table
FILTERS
Therapeutic Area
Select some options
Pharmaceutical Form
Select some options
Zone IV Stability
Select some options
CPP Feasibility
Select some options
PRODUCT NAME
THERAPEUTIC AREA
PHARMACEUTICAL
FORM
VISUAL
FORM
STRENGTH
REFERENCE
PRODUCT
lactose
Stability Zone
CPP
FEASIBILITY
Alimentary tract & metabolism
Film-coated tablets
5 mg
10 mg
Forxiga / Astra Zeneca
II: on-going
IVa: ext. From b
IVb: on-going
No
Alimentary tract & metabolism
Film-coated tablets
5 mg
Trajenta / Boehringer Ingelheim
II: on-going
IVa: ext. From b
IVb: on-going
No
Alimentary tract & metabolism
Powder for solution for infusion or injection
40 mg
Losec / AstraZeneca
II: available
IVa: not available
IVb: not available
Yes
Alimentary tract & metabolism
Hard capsules
60 mg
Alli / GSK
II: available
IVa: not available
IVb: not available
Yes
Alimentary tract & metabolism
Hard capsules
120 mg
Xenical / Roche
II: available
IVa: not available
IVb: not available
Yes
Alimentary tract & metabolism
Powder for solution for infusion or injection
40 mg
Pantozol / Altana
II: available
IVa: not available
IVb: not available
Yes
Alimentary tract & metabolism
Film-coated tablets
25 mg
50 mg
100 mg
Januvia / Merck
II: on-going
IVa: ext. From b
IVb: on-going
No
Alimentary tract & metabolism
Film-coated tablets
50/850 mg
50/1000 mg
Janumet / Merck
II: on-going
IVa: ext. From b
IVb: on-going
No
Anti-infectives for systemic use
Tablets
200 mg
400 mg
800 mg
Zovirax / GSK
II: available
IVa: not available
IVb: not available
Yes
Anti-infectives for systemic use
Powder for solution for infusion or injection
500 mg
Klacid IV / Abbott
II: available
IVa: not available
IVb: not available
Yes
Anti-infectives for systemic use
Film-coated tablets
500 mg
Tavanic / Aventis
N/A
No
Antineoplastic & Immunomodulating Agents
Capsules
2.5 mg
5 mg
7.5 mg
10 mg
15 mg
20 mg
25 mg
Revlimid / Celgene
II: on-going
IVa: ext. From b
IVb: on-going
No
Blood & Blood forming organs
Film-coated tablets
2.5 mg
5 mg
Eliquis / Bristol-Myers Squibb
II: on-going
IVa: ext. From b
IVb: on-going
No
Blood & Blood forming organs
Film-coated tablets
2.5 mg
10 mg
15 mg
20 mg
Xarelto / Bayer
II: on-going
IVa: ext. From b
IVb: on-going
No
Blood & Blood forming organs
Film-coated tablets
60 mg
90 mg
Brilique / AstraZeneca
II: available
IVa: ext. From b
IVb: available
No
Cardiovascular System
Tablets
5 mg
10 mg
20 mg
Xanef (Vasotec, Renitec) / MSD
II: on-going
IVa: not available
Ivb: not available
No
Cardiovascular System
Film-coated tablets
5 mg + 10 mg
10 mg + 10 mg
10 mg + 20 mg
5 mg + 20 mg
Norvasc (Amlodipine)+Sortis (Atorvastatin) / Pfizer
II: available
IVa: not available
IVb: not available
Yes
Cardiovascular System
Tablets
12.5 mg
25 mg
50 mg
Esidrex / Novartis
II: available
IVa: not available
IVb: not available
Yes(3)
Cardiovascular System
Hard capsules
5 mg + 5 mg
5 mg + 10 mg
10 mg + 5 mg
10 mg + 10 mg
Tritace (Ramipril) / Sanofi & Norvasc (Amlodipine) / Pfizer
II: available
IVa: not available
IVb: not available
Yes
Cardiovascular System
Film-coated tablets
5 mg
10 mg
20 mg
40 mg
Crestor / AstraZeneca
II: available
IVa: not available
IVb: not available
Yes
* Polpharma Group API
CA Dossier suitable for Canadian Market
(1) No CPP feasibility for Hydrochlorothiazide 50 mg
(2) Dossier availability subject to some restriction
(3) Delayed release capsules, as per CA standard Terms
(4) BEQ study against Canadian reference product available
(5) Pending dossier update (new API Valsartan source required)
(6) Only for higher Strength: 1 mg/ml + 50 mg/ml (10 ml)
^ This product is not offered for sale or made available in Germany due to patent (SPC) protection.
Dossier ready to file
No contains lactose
DISCLAIMER
Products protected by patents (SPC) in Poland are developed solely for the purpose of Regulatory Submissions or R&D purposes intended to support Regulatory Submissions. These products are not offered for sale or made available in countries where such products are subject to patent (SPC) protection and where the offer for sale or any related activity constitutes patent infringement. It is within the buyer’s responsibility and liability to check the patent situation of the product in the import market(s).
Based on exemption under art. 5(2) of the Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products Apixaban, Rivaroxaban and Ticagrelor, which are protected by SPCs in Poland, can be manufactured and offered only for the purpose of export to non-EU countries, provided all requirements of the Regulation are met.
Our Portfolio
* Polpharma Group API
CA Dossier suitable for Canadian Market
(1) No CPP feasibility for Hydrochlorothiazide 50 mg
(2) Dossier availability subject to some restriction
(3) Delayed release capsules, as per CA standard Terms
(4) BEQ study against Canadian reference product available
(5) Pending dossier update (new API Valsartan source required)
(6) Only for higher Strength: 1 mg/ml + 50 mg/ml (10 ml)
^ This product is not offered for sale or made available in Germany due to patent (SPC) protection.
