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Dossier Portfolio 2012

AVAILABLE DOSSIERS IN EU CTD FORMAT
Product Form Strenghts

novel generic products

Availability

Under Development

Alimentary tract and metabolism

Levocarnitine Inj. Glimepiride Aprepitant Inj. Sol. 5 ml amp Tablets Capsules Inj Sol./Conc. Sol. Inf.5ml amp Sachets Effervescent Granules Powder & Solvent for Oral Solution Lyophilized powder for solution inj. F.C.Tablets F.C.Tablets Orodispersible Tables Capsules 1g / 5ml & 2g /5ml 1,2,3,4mg/tab 40, 80 & 125mg 100 mg Fe+++ / amp. 5ml 695 mg ( 80mg Fe++) 160 mg ( 20mg Fe++) 0.5 & 1.5mg 10, 20, 40 & 80mg/tab. 62.5 & 125mg 32mg 10 & 25 mg Available Q2 2012 Q2 2012 Q2 2012 Available Available Q3 2012 Available Available Available Q2 2012

Blood and blood forming organs

Iron Sucrose Complex Ferrous Gluconate Ferrous Gluconate ( for pediatric use ) Epoprostenol

Cardiovascular system
Atorvastatin Bosentan Bosentan

D G H

Dermatologicals
Acitretin

Genito urinary system and sex hormones Systemic hormonal preparations

Paricalcitol Cinacalcet Salmon Calcitonin Inj Sol 1 or 2 ml vial or amp Tablets Nasal Spray F.C.Tablets Sachets Granules for oral solution F.C.Tables Or. Susp 60 or 100ml Tablets O.D., Orodispersible Tablets Capsules Solution for injection F.C.Tablets F.C.Tablets F.C.Tablets F.C.Tablets F.C.Tablets Lyophilized powder & solvent for inj.sol. Concetrate for Solution for injection Solution for infusion Concetrate for Solution for injection 2 & 5mcg / ml 30, 60 & 90mg 100 & 200 IU / Dose 250, 500 & 600mg/tab., 2x3 & 1x3gr 500mg/tab 250mg/5ml 500mg/tab 500mg 100, 150 & 200mg/tab. 10mg/ml 25, 100 & 150mg 25mg 150 & 500mg 100 & 400mg 1mg 20mg 4mg/5ml 5mg/100ml 4mg/100ml Available Q3 2012 Available Available Available Available Available Available Available Available Available Q4 2012 Available DCP on-going DCP on-going Available Available DCP Finalized DCP on-going DCP Booked 7-2012

Antiinfectives for systemic use

Azithromycin Fosfomycin Trometamol Clarithromycin Clarithromycin Clarithromycin Clarithromycin OD Fluconazole

Antineoplastic and immunomodulating agents

Vinorelbine Erlotinib Exemestane Capecitabine Imatinib Anastrozole

Musculo-skeletal system
Tenoxicam Zoledronic Acid Zoledronic Acid Zoledronic Acid

Alendronate Sodium Risendronate Sodium

Tablets F.C.Tablets F.C.Tablets Tablets Oral sol. 100ml bottle F.C.Tablets F.C.Tablets Concetrate for Solution for inj. Oral solution F.C.Tablets Orodispersible Tables Orodispersible Tables Orodispersible Tables

70 mg/tab 75mg/tab 5 & 10mg/tab. 0.088, 0.18, 0.35 & 0.7mg/tab 1mg/ml 25,50,100,150,200,300 mg 250, 500, 750 & 1000 mg 100 mg/ml 100mg/ml 5, 10, 15 & 30mg 10 & 15mg 5, 10, 15 & 20mg 5, 10, 15 & 20mg

Available Q1 2012 Available Available Available DCP Finalized DCP Finalized DCP Finalized DCP Finalized Q3 2012 Q3 2012 DCP on-going DCP on-going

Nervous system
Donepezil Pramipexole Risperidone Quetiapine Levetiracetam Levetiracetam Levetiracetam Aripiprazole Aripiprazole Escitalopram Memantine ODT

P R S

Antiparasitic products, insecticides and repellents Respiratory system Sensory organs

Dorzolamide Dorzolamide+Timolol Latanoprost Latanoprost+Timolol Travoprost Travoprost+Timolol Bimatoprost Bimatoprost+Timolol Levofloxacin Hemyhidrate Tobramycin + Dexamethasone Eye drops Sol. 5 ml vial Eye drops Sol. 5 ml vial Eye drops Sol. 2.5 ml vial Eye drops Sol. 2.5 ml vial Eye drops Sol. 2.5 ml vial Eye drops Sol. 2.5 ml vial Eye drops Sol. 3 ml vial Eye drops Sol. 3 ml vial Eye drops Sol. 5 ml vial Eye drops Susp. 5 ml vial 0,02 (2.0 + 0.5)% 50mcg / ml (50 mcg + 5.0 mg) / ml 40.0mcg/ml 40.0mcg/ml + 5.0mg/ml 0.3mg/ml 0.3mg/ml + 5.0mg/ml 5.0 mg/ml (0.3 + 0.1) % Available Available Available Available Q1 2012 Q1 2012 Q1 2012 Q2 2012 Available Available

Various

For more information and updates regarding available dossiers and dossiers in development , please contact our Business Development Department. Note: Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. Availability may be restricted to certain markets or countries.

novel generic pharmaceutical products development

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