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export-table

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

Cardiovascular System
Tablets
5 mg
10 mg
20 mg
Xanef (Vasotec, Renitec) / MSD

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

No
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
Tablets
12.5 mg
25 mg
50 mg
Esidrex / Novartis

II: available
IVa: not available
IVb: not available

Yes(3)
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
Cardiovascular System
Film-coated tablets
5 mg
10 mg
20 mg
40 mg
Crestor / AstraZeneca

II: available
IVa: not available
IVb: not available

Yes
Cardiovascular System
Tablets
40/5 mg
40/10 mg
80/5 mg
80/10 mg
Twynsta / Boehringer Ingelheim

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

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)

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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* 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.