Business Development

Azithromycin

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme T = 36 months
Bioequivalence study Performed in R&D Solution Reference product: Italian
Approved	PT, ES, IT
Available MA's	PT, IT, ES

Atorvastatin

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme Climatic Zone II T = 12 months Climatic Zone IVB T = 9 months	End: 02/2013
Bioequivalence study Performed in IPRC Reference product: Spain	ongoing
Approved	-
Available MA's	-

Candesartan

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme	End: 11/2013
Bioequivalence study Performed in Anapharm Reference product: France
Approved	NL, BG, CZ, EE, HU, LT, LV, PL, RO, SK, UK, BE, ES, IT, DE, EL, DK, FI, NO, SE, PT
Available MA's	NL, DE, FR, IT, CZ

Losartan

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme	T=60 Months End: 12/2011
Bioequivalence study Performed in Algorithme Pharma Reference product: France
Approved	PT, IT, ES, FR, DE, SE, NL, UK, AT, BE, HU, DK, FI, NO
Available MA's	AT, BE, DE, DK, ES, FI, FR, HU, IT, NL, NO, PT, SE, UK

Ramipril

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme T = 24 months
Bioequivalence study Performed in Algorithme Pharma Reference product: France
Approved	PT, ES
Available MA's	PT

Irbesartan

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme	End: 8/2012
Bioequivalence study Performed in Algorithme Pharma Reference product: DE and USA
Approved	PT
Available MA's	USA, UK, BE, DE, DK, EL, ES, FR, HU, IT, NO, PT, SE

Levetiracetam (tablets)

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme	End: 4/2012
Bioequivalence study Performed in Algorithme Pharma Reference product: DE
Approved	AU
Available MA's	Contact us

Ask for further details by e-mail at business@bluepharma.pt

Acarbose

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme T = 36 months	End: 08/2011
Bioequivalence study Biowaiver
Approved	PT, ES, DE, FR, USA
Available MA's	PT

Clarithromycin

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme T = 36 months	End: 09/2011
Bioequivalence study Performed in Algorithme Pharma Reference product: France
Approved	PT, ES, FR, IT
Available MA's	PT, IT

Candesartan + HCTZ

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme	End: 11/2013
Bioequivalence study Performed in Anapharm Reference product: France
Approved	NL, BG, CZ, EE, HU, LT, LV, PL, RO, SK, UK, BE, ES, IT, DE, EL, DK, FI, NO, SE, PT
Available MA's	NL, DE, FR, IT, CZ

Losartan + HCTZ

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme	T=60 Months End: 8/2012
Bioequivalence study Performed in ACC GmbH Reference product: France
Approved	PT, IT, ES, FR, DE, SE, NL, UK, AT, BE, HU, DK, FI, NO
Available MA's	AT, BE, DE, DK, ES, FI, FR, HU, IT, NL, NO, PT, SE, UK

Nimesulide (new dossier)

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme T = 24 months
Bioequivalence study Reference product: France	under preparation
Approved	PT
Available MA's	-

Irbesartan + HCTZ

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme	End: 8/2012
Bioequivalence study Performed in Algorithme Pharma Reference product: DE and USA
Approved	-
Available MA's	USA, UK, BE, DE, DK, EL, ES, FR, HU, IT, NO, PT, SE

Levetiracetam (oral solution)

Task	Status
Galenical development
Development and validation of analytical methods
Manufacturing and packaging of validation batches
ICH stability programme
Approved	-
Available MA's	Contact us