Available dossiers - Farmaprojects

Welcome,

FILTERS

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

Alimentary tract & metabolism

Film-coated tablets

5 mg

Trajenta / Boehringer Ingelheim

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

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

Alimentary tract & metabolism

Film-coated tablets

50/850 mg

50/1000 mg

Janumet / Merck

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

* 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)

Dossier ready to file

No contains lactose

DISCLAIMER
The above list is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.

* 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)

Dossier ready to file

No contains lactose

DISCLAIMER
The above list is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.

Legal information

For more information and updates regarding available dossiers and dossiers under development please contact Sales Department.
DISCLAIMER: The above list is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.

For more information and updates regarding available dossiers and dossiers under development please contact Sales 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 restricted to certain markets or countries.

Our Portfolio

FILTERS

PRODUCT NAME

THERAPEUTIC AREA

PHARMACEUTICAL
FORM

VISUAL
FORM

STRENGTH

REFERENCE
PRODUCT

lactose

Stability Zone

CPP
FEASIBILITY

* 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)

Dossier ready to file

No contains lactose

DISCLAIMER
The above list is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.

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)

Dossier ready to file

No contains lactose

DISCLAIMER
The above list is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.

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Legal information

Pages

Legal information

Contact Sales Team

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Our Portfolio

Export table

FILTERS

PRODUCT NAME

THERAPEUTIC AREA

PHARMACEUTICALFORM

VISUALFORM

STRENGTH

REFERENCEPRODUCT

lactose

Stability Zone

CPP FEASIBILITY

* 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)

Dossier ready to file

No contains lactose

DISCLAIMER The above list is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.

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)

Dossier ready to file

No contains lactose

DISCLAIMER The above list is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.

Pages

Legal information

Pages

Legal information

Contact Sales Team

FILTERS

PHARMACEUTICAL
FORM

VISUAL
FORM

REFERENCE
PRODUCT

CPP
FEASIBILITY

^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)

DISCLAIMER
The above list is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.

^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)

DISCLAIMER
The above list is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.