BUSINESS OPPORTUNITIES

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Oct. 25th - 27th - 2011
CPHI Frankfurt - Germany
March 12th - 15th - 2012
DCAT New York - USA

LAST NEWS
NEW MAA CESSION & TRANSFER
Licensing-out opportunity Donepezil 5 mg, ODT (NL37771) and Donepezil 10 mg, ODT (NL37772)
MAA CESSION & TRANSFER
Licensing-out opportunity Fenofibrate 67 mg, tablet (NL27271) - Fenofibrate 200 mg, tablet (NL27274) and Fenofibrate 160 mg, modified release tablet (NL31360)
MAA CESSION & TRANSFER
Licensing-out opportunity Cetirizine 10 mg/ml, oral solution (NL33352)
2011 - Certificate of GMP compliance of a Manufacturer for Human investigational medicinal product

2011 - Certificate of GMP compliance of a Manufacturer for Human medicinal product

2009 - cGMP Agreement for human use

Galenix Pharma has obtained an updated agreement for cGMP manufacturing, importation and ditribution of human and investigational medicinal products AFSSAPS #M09/168
2008 - cGMP Agreement for veterinary use

Galenix Pharma has obtained an agreement for cGMP manufacturing, importation and distribution of veterinary and investigational medicinal products AFSSA #V1515/08

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Generic and LCM products pipeline Pre-clinical Clinical Batch Phase I Registration Market authorization Launch
Antihistaminic therapy: Cetirizine 10 mg/ml Oral solution (drops) Granted in March 2007
Antiviral therapy: Valacyclovir 500 mg and 1 g Orodispersible/dispersible tablet - LCM ODTx® Q2/2012
Antiviral therapy: Valacyclovir 375 mg and 750 mg MR tablet - LCM Microgix® Q4/2011
Brain disorder therapy: Risperidone 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg Orodispersible/dispersible tablet - ODTx® Q3/2011
Cardiovascular therapy: Celiprolol 200 mg Coated tablet Granted
Dermatology therapy: Ketoconazole Gel 2% Tube and stick-pack Feb. 2008
Gastro-enterology therapy - Antiacid + PPI: Esomeprazole 20 mg and 40 mg IR Orodispersible delayed tablet - LCM Microgix® Q3/2012
Gastro-enterology therapy - Antiacid + PPI: Lansoprazole 15 mg and 30 mg IR Orodispersible delayed tablet - LCM Microgix® Q3/2012
Gastro-enterology therapy - Antiacid + PPI: Pantoprazole 15 mg and 30 mg IR Orodispersible delayed tablet - LCM Microgix® Q4/2012
Gastro-enterology therapy: Domperidone 10 mg Orodispersible tablet - ODTx® + Patent Granted in Dec. 2006
Gastro-enterology therapy: Lansoprazole 15 mg and 3 mg Delayed orodispersible tablet - Microgix® Q2/2012
Metabolism therapy - antialzheimer application: Donepezil 5 mg and 10 mg Orodispersible tablet - ODTx® Q2/2011
Metabolism therapy - Antidiabetic oral application: Metformine 500 mg, 850 mg and 1 g Orodispersible/dispersible tablet - LCM ODTx® Metformine 500mg, 850mg, 1000mg - Exclusive licence for European Territory Nov. 2007
Metabolism therapy - Association of two anti-Alzheimer agents: Donepezil/Memantin 10 mg/10 mg Orodispersible/dispersible tablet - LCM ODTx® Q4/2011
Metabolism therapy - Hypolipidemic application: Fenofibrate 145 mg MR Tablet - LCM Microgix® + Patent Q2/2012
Metabolism therapy - Hypolipidemic application: Fenofibrate 160 mg Modified release Tablet - Patent Granted in Feb. 2006
Metabolism therapy - Hypolipidemic application: Fenofibrate 200 mg Tablet - Patent Granted in Feb. 2003
Metabolism therapy - Hypolipidemic application: Fenofibrate 67 mg Tablet - Patent Feb. 2003
Opioid addiction therapy: Buprenorphine/naloxone 2 mg/0.5 mg and 8 mg/2 mg Orodispersible tablet - ODTx® + Patent Q3/2012
Osteoporosis therapy - Pain relief application: Chondroitin/Glucosamin 400 mg/1250 mg Orodispersible/dispersible tablet - LCM ODTx® Q2/2012
Osteoporosis therapy : Chondroitin 400 mg and 500 mg Orodispersible/dispersible tablet - LCM ODTx® Q2/2012
Osteoporosis therapy: Risedronate 35 mg + Ca 2 + Vit. D3 Coated tablet Q2/2012
Osteoporosis therapy: Risedronate 35 mg Coated tablet Q4/2011
Pain disease therapy: Acetaminophen 1g Tablet - Minextab® + Patent March 2004
Supplement therapy - Vitamin application: Calcium/Cholecalceferol (Vit. D3) 1000 mg/800 ui Chewable dispersible tablet Q4/2011
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