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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

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
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
Anti-infectives for systemic use
Film-coated tablets
500 mg
Tavanic / Aventis

N/A

No
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

No
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

No
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

No
Blood & Blood forming organs
Film-coated tablets
60 mg
90 mg
Brilique / AstraZeneca

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

No
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

* 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.