Our Portfolio

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

Nervous system
Gastro-resistant hard capsules
120 mg
240 mg
Tecfidera / Biogen Idec

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

No
Nervous system
Film-coated tablets
10 mg
20 mg
Ebixa / Lundbeck

II: available
IVa: available
IVb: no ext. From a

Yes
Nervous system
Film-coated tablets
500 mg
Novalgin / Sanofi Aventis

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

No
Nervous system
Film-coated tablets
25 mg
100 mg
150 mg
200 mg
300 mg
Seroquel / AstraZeneca

II: available
IVa: available
IVb: 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)

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.