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export-table

Export table

FILTERS

Therapeutic Area
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Pharmaceutical Form
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Zone IV Stability
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CPP Feasibility
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Available Dossiers
Under Development

PRODUCT NAME

THERAPEUTIC AREA

PHARMACEUTICAL
FORM

VISUAL
FORM

STRENGTH

REFERENCE
PRODUCT

lactose

Stability Zone

CPP
FEASIBILITY

Apixaban^
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
Rivaroxaban* CA^
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
Ticagrelor* (1)^
Blood & Blood forming organs
Film-coated tablets
60 mg
90 mg
Brilique / AstraZeneca

II: available
IVa: ext. From b
IVb: available

No

* 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

Available Dossiers
Under Development

* 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.