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Export table
FILTERS
PRODUCT NAME
THERAPEUTIC AREA
PHARMACEUTICAL
FORM
VISUAL
FORM
STRENGTH
REFERENCE
PRODUCT
lactose
Stability Zone
CPP
FEASIBILITY



II: on-going
IVa: ext. From b
IVb: on-going


II: on-going
IVa: ext. From b
IVb: on-going


II: available
IVa: not available
IVb: not available


II: available
IVa: not available
IVb: not available


II: available
IVa: not available
IVb: not available


II: available
IVa: not available
IVb: not available


II: on-going
IVa: ext. From b
IVb: on-going


II: on-going
IVa: ext. From b
IVb: on-going


II: available
IVa: not available
IVb: not available


II: available
IVa: not available
IVb: not available

N/A

II: on-going
IVa: ext. From b
IVb: on-going

II: on-going
IVa: ext. From b
IVb: on-going

II: on-going
IVa: ext. From b
IVb: on-going


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


II: on-going
IVa: not available
Ivb: not available


II: available
IVa: not available
IVb: not available

II: available
IVa: not available
IVb: not available


II: available
IVa: not available
IVb: not available

II: available
IVa: not available
IVb: not available
* 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.
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* 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.

