Available dossiers – Farmaprojects

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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: not available
IVb: not available

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

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

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

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

Blood & Blood forming organs

Film-coated tablets

60 mg

90 mg

Brilique / AstraZeneca

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

Cardiovascular System

Tablets

5 mg

10 mg

20 mg

Xanef (Vasotec, Renitec) / MSD

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

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

Film-coated tablets

5 mg + 80 mg

5 mg + 160 mg

10 mg + 160 mg

Exforge / Novartis

II: available
IVa: ext. From b
IVb: 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

Solution for injection

1 mg/ml

Betaloc / AstraZeneca

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

Yes

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

* 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)

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⁾ Pending dossier update (new API Valsartan source required)

⁽²⁾ No CPP feasibility for Hydrochlorothiazide 50 mg

⁽³⁾ Dossier availability subject to some restriction

⁽⁴⁾ Delayed release capsules, as per CA standard Terms

⁽⁵⁾ BEQ study against Canadian reference product available

⁽⁶⁾ Only for higher Strength: 1 mg/ml + 50 mg/ml (10 ml)

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)

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⁾ Pending dossier update (new API Valsartan source required)

⁽²⁾ No CPP feasibility for Hydrochlorothiazide 50 mg

⁽³⁾ Dossier availability subject to some restriction

⁽⁴⁾ Delayed release capsules, as per CA standard Terms

⁽⁵⁾ BEQ study against Canadian reference product available

⁽⁶⁾ Only for higher Strength: 1 mg/ml + 50 mg/ml (10 ml)

Pages

Legal information

Pages

Legal information

Contact Sales Team

FILTERS

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)

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) Pending dossier update (new API Valsartan source required)

(2) No CPP feasibility for Hydrochlorothiazide 50 mg

(3) Dossier availability subject to some restriction

(4) Delayed release capsules, as per CA standard Terms

(5) BEQ study against Canadian reference product available

(6) Only for higher Strength: 1 mg/ml + 50 mg/ml (10 ml)

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⁾ Pending dossier update (new API Valsartan source required)

⁽²⁾ No CPP feasibility for Hydrochlorothiazide 50 mg

⁽³⁾ Dossier availability subject to some restriction

⁽⁴⁾ Delayed release capsules, as per CA standard Terms

⁽⁵⁾ BEQ study against Canadian reference product available

⁽⁶⁾ Only for higher Strength: 1 mg/ml + 50 mg/ml (10 ml)