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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
Alimentary tract & metabolism
Film-coated tablets
5/850 mg
5/1000 mg
Xigduo / Astra Zeneca
II: on-going
IVa: ext. From b
IVb: on-going
No
Alimentary tract & metabolism
Film-coated tablets
10 mg
25 mg
Jardiance / Boehringer Ingelheim
II: on-going
IVa: ext. From b
Ivb: on-going
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.
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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.
