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Export table
FILTERS
PRODUCT NAME
THERAPEUTIC AREA
PHARMACEUTICAL
FORM
VISUAL
FORM
STRENGTH
REFERENCE
PRODUCT
lactose
Stability Zone
CPP
FEASIBILITY



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


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


II: available
IVa: not available
IVb: not available


II: available
IVa: not available
IVb: not available


II: available
IVa: not available
IVb: not available


II: available
IVa: not available
IVb: not available


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


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


II: available
IVa: not available
IVb: not available


II: available
IVa: not available
IVb: not available

N/A

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

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

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


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


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


II: available
IVa: not available
IVb: not available

II: available
IVa: not available
IVb: not available


II: available
IVa: not available
IVb: not available

II: available
IVa: not available
IVb: not available
* 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)

