Our Portfolio
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
* 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)

