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Entacapone/ Levodopa/ Carpidopa film-coated tablets [Opportunity for a buyer]
01 May 2013
Generic to Stalevo®/ Novartis. 200mg + 50/12.5; 75/18.75; 100/25; 125/31.25; 150/37.5; 175/43.75; 200/50 mg
Vitamin D3 ATC A11CC05 [Opportunity for a buyer]
19 April 2013
Prevention and treatment of vitamin D deficiency in the elderly.
Omega 3 Acid Ethyl Esters 84% ATC C10AX06 [Opportunity for a buyer]
19 April 2013
Lipid reducers.
Nicorandil ATC C01DX16 [Opportunity for a buyer]
19 April 2013
Vasodilatory for angina treatment.
Imipenem Plus Cilastatin [Opportunity for a buyer]
19 April 2013
Antibiotic ATC J01DH51.
Aciclovir 5% Lipstick [Opportunity for a buyer]
19 April 2013
Lipstick 3g - 5% aciclovir.
Outlicensing Opportunities [Opportunity for a buyer]
01 March 2013
Worldwide commercialisation of generic drug developments via outlicensing, supply and co-distribution.
Loteprednolo and Fluorometolone CTD dossiers and production [Opportunity for a seller]
30 January 2013
We are looking for one European CTD dossier for either Loteprednolo or Fluorometolone in ophthalmic presentation.
Loperamide/Simethicone 2/125mg tablets - outlicensing and supply [Opportunity for a buyer]
22 January 2013
We offer a dossier for Loperamide/Simethicone tablets 2/125mg for outlicensing with supply. Possibility to launch in 2013. The dossier is in English, in e-CTD format and in full compliance with the current EU Notice to Applicants. After the granting of a marketing authorization, we supply the finished product in bulk or finished packs, against competitive prices.
Naproxen Sodium 550mg tablets - outlicensing and supply [Opportunity for a buyer]
22 January 2013
We are offering a dossier for Naproxen Sodium tablets 550mg for outlicensing with supply. The dossier is in English, in e-CTD format and in full compliance with the current EU Notice to Applicants. After the granting of a marketing authorization, we supply the finished product in bulk or finished packs, against competitive prices.
Gliclazide MR tablets 30mg - outlicensing and supply [Opportunity for a buyer]
22 January 2013
We offer a dossier for Gliclazide MR tablets 30mg for out-licensing with supply. We also offer an ‘off the shelf’ MA in the Netherlands which can serve as a basis for an MRP. The dossier is in English, in e-CTD format and in full compliance with the current EU Notice to Applicants. After the granting of a marketing authorization, we supply the finished product in bulk or finished packs, against competitive prices.
Paracetamol granulate in stick packs - outlicensing and supply [Opportunity for a buyer]
22 January 2013
We offer a dossier for Paracetamol granulate in stick packs 250, 500 and 1,000mg for outlicensing with supply. This product can be administered without the use of liquids and is taste masked and flavoured. The dossier is in English, in e-CTD format and in full compliance with the current EU Notice to Applicants. After the granting of a marketing authorization, we supply the finished product against competitive prices.
Flecainide CR capsules - outlicensing & supply [Opportunity for a buyer]
22 January 2013
We offer a dossier for Flecainide CR capsules 50, 100, 150 & 200mg for outlicensing with supply. The dossier is in English, in e-CTD format and in full compliance with the current EU Notice to Applicants. After the granting of a marketing authorization, we supply the finished product in bulk or finished packs, against competitive prices.
Out licensing CTD with long term product Supply for :Sildenafil Tabs, Modafinil Tabs, Pioglitazone Tabs, Deflazacort Tabs, Fluoxetine caps & sol and Rivastigmine caps and sol.
Bisoprolol + HCTZ Dossier Required [Opportunity for a seller]
08 October 2012
We are looking for dossier and supply agreement for the South African market
Escitalopram and Losartan - Out Licensing Dossiers with Supply to EU [Opportunity for a buyer]
11 September 2012
Out Licensing Dossiers with Long Term Product Supply to EU for 1) Escitalopram Tabs and 2) Losatan Potassium Tabs. Out Licensing CTD with Long Term Supply to US, AU, NZ and South Africa
Donepezil, Sildenafil and Gabapentin Out Licensing CTD with Supply [Opportunity for a buyer]
11 September 2012
Out Licensing CTD with Long Term Product Supply for 1) Donepezil Tabs 2) Sildenafil Tabs and 3) Gabapentin Caps
Penems licensing opportunity [Opportunity for a buyer]
10 September 2012
Penems long term competitive supply based on vertically integrated supply base with own patented production of the APIs. Meropenem 500mg & 1g and Imipenem+Cilastatin 500mg+500mg are available. Ertapenem (non-infringing process) in development.
Dossier and supply of hydroxyzine hydrochloride generic Atarax [Opportunity for a seller]
03 September 2012
We are looking for a dossier and supply of finished product.
Dossiers needed for UK Germany Scandinavia and China [Opportunity for a seller]
03 September 2012
Looking for Dossiers for Uk Germany Scandinavia and China market
Amiodarone Hydrochloride in Ampoules and Vials, 50mg/ml, 3ml amps, 3ml and 6ml Vials. Fluconazole infusion in non PVC single port option 2mg/ml, 50ml, 100ml and 200mL.
Travoprost eye drops, generic of Travatan [Opportunity for a buyer]
28 August 2012
Available for out-licensing. E-CTD dossier with clinical study.
Dossiers in ACTD for oncology products [Opportunity for a buyer]
25 August 2012
ALL ONCOLOGY PRODUCT DOSSIERS
Aripiprazol 5/ 10/ 15/ 30 mg tablets [Opportunity for a buyer]
23 August 2012
Generic to Abilify® ex BMS/ Otsuka
Bosentan 62.5 and 125 mg film coated tablets [Opportunity for a buyer]
23 August 2012
Generic to Tracleer®/ Roche
Tirofiban vial and bags [Opportunity for a buyer]
23 August 2012
Generic to Aggrastat®/ Iroko 50 mcg/ml – 250 ml bags infusion solution 250 mcg/ml – 50 ml vials concentrate
Eplerenone 25 and 50 mg film coated tablets [Opportunity for a buyer]
23 August 2012
Generic to Inspra®/ Pfizer. EU manufacturer.
Prednisolone Oral Solution 10 mg/ml – Super Generic [Opportunity for a buyer]
23 August 2012
DCP Ongoing - Regulatory Classification: Medicinal product / Generic application - Therapeutic Indication: Suppression of inflammatory and allergic disorders. The indications include a wide spectrum of conditions including: arteritis/collagenosis, blood, cardiovascular, endocrine, gastro-intestinal disorders, hypercalcaemia, infections (with appropriate chemotherapy), renal disorders (with appropriate chemotherapy), neurological disorders, ocular, respiratory disease, rheumatic disorders and skin disorders. - ATC Code: H02AB06 - Active Ingredient: Prednisolone Sodium m-Sulfobenzoate - Market Need: Innovative strength; no commercial oral liquid product under the proposed strength - Shelf Life: 36 months (under evaluation)
Dossier submitted nationally in Greece. Registration process ongoing. - Regulatory Classification: Medicinal product - Therapeutic Indication: Prevention and treatment of secondary hyperparathyroidism in patients with chronic renal failure undergoing haemodialysis. - ATC Code: H05BX02 - Active Ingredient: Paricalcitol -Market Need: Generic version to Zemplar® solution for injection. - Shelf Life: 24 months
Folic Acid Oral Solution 10mg/ml – Super Generic [Opportunity for a buyer]
23 August 2012
DCP Ongoing. - Regulatory Classification: Medicinal product/ Well-established application - Therapeutic Indication: Treatment of megaloblastic anemia due to a deficiency of folic acid as may be seen in tropical or non-tropical sprue, in anemia of nutritional origin, pregnancy, infancy, or childhood, haemolytic anemia and folate deficiencies caused by medicines or kidney dialysis. - ATC Code: B03BB01 - Active Ingredient: Folic Acid - Market Need: Innovative strength; no commercial product under the proposed strength. - Shelf Life: 24 months
DCP scheduled in September 2012 - Regulatory Classification: Medicinal product - Therapeutic Indication: Symptomatic treatment of mild to moderately severe Alzheimer''s dementia - ATC Code: N06DA02 - Active Ingredient: Donepezil Hydrochloride 1mg/ml - Market Need: Unique generic donepezil – based oral solution; Non-infringing formulation - Shelf Life: 36 months
Dexamethasone Oral Solution 4 mg/ml – Super Generic [Opportunity for a buyer]
23 August 2012
DCP Scheduled in January 2013 - Regulatory Classification: Medicinal product / Well-established application - Therapeutic Indication: Treatment of a wide variety of disorders amenable to glucocorticoid therapy, in certain endocrine and non-endocrine disorders, in certain cases of cerebral oedema and for diagnostic testing of adrenocortical hyperfunction. - ATC Code: H02AB02 - Active Ingredient: Dexamethasone Sodium Phosphate - Market Need: Innovative strength; no commercial oral liquid product under the proposed strength - Shelf Life: 36 months (under evaluation)
Paracetamol 665 mg (IR + SR) [Opportunity for a seller]
22 August 2012
Ready EU CTD dossier required
Value Added Generics - tapentadol; leviterecetam + others [Opportunity for a buyer]
22 August 2012
Tapentadol OD, Leviterecetam ER, Mesalazine OD, Levonorgesterel + Meclizine and others
Zoledronic acid 4mg/100ml & 5mg/100ml - PVC free bags [Opportunity for a buyer]
22 August 2012
Biomendi-Genfarma, Spain is offering zoledronic acid 4mg/100ml and 5mg/100ml - pvc free bags
Nicotine Chewing Gum [Opportunity for a buyer]
16 August 2012
Alkalon offers a range of finished product formulations and is seeking partnership opportunities worldwide. 2 and 4 mg available in several flavours. Our Nicotine Polacrilex Chewing Gum portfolio is based on a high quality dossier and has received MA's in several EU countries.
German marketing authorization is approved in 2012 and available for licensing-in. Rights for other countries can be made available. - Regulatory Classification: Medicinal product - Therapeutic Indication: Systematic use as an analgesic to relieve mild to moderate pain, and as an antipyretic to reduce fever - ATC Code (3rd level): N02B Other analgesics and antipyretics - Active Ingredients: Acetylsalicylic acid (ASA) 500 mg / stick - Market Need: First generic version to Aspirin® effect; opportunity in pain/cold indications; interesting line extension for pain brands - Flavor: Lemon - Shelf Life: 36 months
Nifedipine XL: A Generic Product to Procardia XL; Adalat XL [Opportunity for a buyer]
03 August 2012
This generic product is launched in the USA, Canada and South Korea in 30, 60 and 90 mg. strengths, however a second formulation is available for license for Canada and South Korea.
Generic Exenatide: A Generic Product to Byetta and Bydureon [Opportunity for a buyer]
03 August 2012
This generic product is under development and is available for license worldwide.
Omalizumab mAb: Biosimilar to Xolair [Opportunity for a buyer]
03 August 2012
This API is highly similar to Xolair and is fully documented, with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals. It will complete phase I pK/PD comparative clinical studies in European humans in late 2014.
Golimumab mAb: Biosimilar to Simponi [Opportunity for a buyer]
03 August 2012
This API is highly similar to Simponi and is fully documented, with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals. It will complete phase I pK/PD comparative clinical studies in European humans in 3Q of 2016
Ranibizumab mAb: Biosimilar to Lucentis [Opportunity for a buyer]
03 August 2012
This API is highly similar to Lucentis and is fully documented, with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals. It will complete phase I pK/PD comparative clinical studies in European humans in late 2015.
Tocilizumab mAb: Biosimilar to Actemra [Opportunity for a buyer]
03 August 2012
This API is highly similar to Actemra and is fully documented, with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals. It will complete phase I pK/PD comparative clinical studies in European humans in 2Q of 2016
Palivizumab mAb: Biosimilar to Synagis [Opportunity for a buyer]
03 August 2012
This API is highly similar to Synagis and is fully documented, with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals. It will complete phase I pK/PD comparative clinical studies in European humans in the 3rd quarter of 2014
Abatacept fusion protein: Biosimilar to Orencia [Opportunity for a buyer]
02 August 2012
This API is highly similar to Orencia and is fully documented, with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals. It will complete phase I pK/PD comparative clinical studies in European humans in early 2016
Natlizumab mAb: Biosimilar to Tysabri [Opportunity for a buyer]
02 August 2012
This API is highly similar to Tysabri and is fully documented, with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals. It will complete phase I pK/PD comparative clinical studies in European humans in the 3Q of 2015.
Generic Enoxaparin approved with EU Guideline content [Opportunity for a buyer]
02 August 2012
Many countries follow the EU guidelines on biosimilars which specify that enoxaparin as a biosimilar requires extensive comparability characterization with nonclinical and human clinical studies with the reference product Clexane.
Dronedarone - generic Multaq [Opportunity for a buyer]
02 August 2012
Multaq is the first anti-arrhythmia drug approved since amiodarone was approved in 1985. We are developing a non-infringing generic.
Risperdone Injectable Depot: A Generic to Risperdal Consta [Opportunity for a buyer]
01 August 2012
This is an extended release injection product that is being developed as an ANDA and as an EU CTD MAA.
Biosimilar Liquid Etanercept Noninfringing to L-Arginine patent [Opportunity for a buyer]
01 August 2012
This room temperature liquid formulation of etanercept has been proven to work at the following stability temperatures: Real Time (RT: 5ºC) Accelerated (AT: 25ºC) Stress (ST: 40ºC) Elevated (ET: 50ºC)
Infliximab mAb: Biosimilar to Remicade [Opportunity for a buyer]
01 August 2012
This API is highly similar to Remicade and is fully documented, with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals. It will complete phase I pK/PD comparative clinical studies in European humans in late 2013.
This API is highly similar to Herceptin and is fully documented, with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals. It will complete phase I pK/PD comparative clinical studies in European humans in the 2013
Lanreotide LAR: generic Somatuline Depot [Opportunity for a buyer]
01 August 2012
The product is a 30-day depot formulation being developed as an EU CTD MAA.
The oral dispersible tablets are available in 125, 250 and 500 mg strengths.
Generic Glatiramer Acetate Prefilled Syringes [Opportunity for a buyer]
23 July 2012
Generic Glatiramer Acetate Prefilled Syringes (PFS) is Ready for Filing as USA ANDA in 2013. Generic glatiramer in PFS will be available to file as a USA ANDA in 2013 and as a EU MAA in eCTD in 2014.
Biosimilar Imiglucerase [Opportunity for a buyer]
23 July 2012
Imiglucerase is a biosimilar of Genzyme’s Cerezyme®, approved for the treatment of Gaucher’s disease, the most prevalent genetic metabolic disorder caused by a deficiency of glucocerebrosidase enzyme. The only therapeutic treatment for Gaucher disease is enzyme replacement therapy. Imiglucerase is a monomeric glycoprotein with 497 amino acids and has four N-glycosylation sites expressed in CHO cells.
Available for out-licensing. e-CTD dossier.
CTDs available with product supply [Opportunity for a buyer]
17 July 2012
CTDs available with product supply
Rosuvastatin 5, 10, 20, 40 mg film-tablet [Opportunity for a buyer]
17 July 2012
EU CTD ready.
Aripiprazole 5,10,15,30mg film-tablets [Opportunity for a buyer]
17 July 2012
EU CTD ready.
Duloxetine 20,30,40,60 mg capsules [Opportunity for a buyer]
17 July 2012
CTD ready by 12.2013.
Strontium ranelate 2g granules for oral suspension (sachet) [Opportunity for a buyer]
17 July 2012
EU CTD ready. Successful BE result. Manufactured at EU GMP certfied plant.
This API is highly similar to MabThera and is fully documented, with stability according to EU requirements; with regulatory analytics; and, proof of comparability. It will complete phase I pK/PD comparative clinical studies in European humans in 2014.
This API is highly similar to Avastin and is fully documented, with stability according to EU requirements; with regulatory analytics; and, proof of comparability. It will complete phase I pK/PD comparative clinical studies in European humans in early 2014
This once-daily generic product treats attention deficit disorder (ADHD) and is available for license in Europe which a DCP slot is scheduled for June 2013. It is manufactured in an EU cGMP inspected facility.
This API is highly similar to Humira and is fully documented, with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals. It will complete phase I pK/PD comparative clinical studies in European humans in early 2014
These generic tacrolimus capsules with an eCTD dossier are formulated to meet the confidence limits of 90-110% required by the MEB in Europe. The dossier is widely approved in Europe. This dossier is available to register in countries recognizing the European CTD. We also have a USA ANDA that is filed with the 90-110% confidence limits which is available to register in countries recognizing the USA ANDA.
This product is identical in every respect to Seretide Diskus; MAA is filed in the EU in 2012, and is still available for license in some countries, especially countries outside of Europe
Octreotide LAR: A Generic to Sandostatin LAR [Opportunity for a buyer]
11 July 2012
The product is a 30-day depot formulation being developed as an EU CTD MAA.
Actavis has developed this new business model which will be available for sale soon - Opening Pharma Germany - a legal entity which will include a portfolio of marketing authorisations (MAs). This concept allows super-fast entrance into new markets compared to starting up a new business or acquiring an established sales company. Purchase of this entity, together with the underlying MAs, will significantly reduce investment costs. This opportunity is particularly suited for companies looking to diversify cash flow streams and having API & Finished Product manufacturing. Limited due-diligence is required as the legal entity is newly established and contains only the selected MAs.
Actavis has developed this new business model to offer for sale Opening Pharma Russia - a legal entity which will include a portfolio of marketing authorisations (MAs). This concept allows super-fast entrance into new markets compared to starting up a new business or acquiring an established sales company. Purchase of this entity, together with the underlying MAs, will significantly reduce investment costs. This opportunity is particularly suited for companies looking to diversify cash flow streams and having API & Finished Product manufacturing. Limited due-diligence is required as the legal entity is newly established and contains only the selected MAs.
Actavis has developed this new business model to offer for sale Opening Pharma Bulgaria - a legal entity which will include a portfolio of marketing authorisations (MAs). This concept allows super-fast entrance into new markets compared to starting up a new business or acquiring an established sales company. Purchase of this entity, together with the underlying MAs, will significantly reduce investment costs. This opportunity is particularly suited for companies looking to diversify cash flow streams and having API & Finished Product manufacturing. Limited due-diligence is required as the legal entity is newly established and contains only the selected MAs.
Actavis has developed this new business model to offer for sale Opening Pharma France SAS - a legal entity which will include a portfolio of 60 marketing authorisations (MAs). This concept allows super-fast entrance into new markets compared to starting up a new business or acquiring an established sales company. Purchase of this entity, together with the underlying MAs, will significantly reduce investment costs. This opportunity is particularly suited for companies looking to diversify cash flow streams and having API & Finished Product manufacturing. Limited due-diligence is required as the legal entity is newly established and contains only the selected MAs.
Various EU MAs for sale [Opportunity for a buyer]
24 November 2011
MAs and ongoing submissions available for: Pantoprazole 40mg IV Paracetamol 10mg/ml IV, Zoledronic Acid 4mg/5ml and 5mg/100ml Xylomethazoline Nasal Spray and Drops Fusidic Acid 2% Cream
Penicillin-V filmcoated tablets [Opportunity for a buyer]
24 November 2011
Penicillin-V filmcoated tablets 660mg, 800mg, 1000mg
Methylprednisolone tablets [Opportunity for a buyer]
09 September 2011
Methylprednisolone tablets 4, 16 & 32 mg
Prednisolone tablets [Opportunity for a buyer]
09 September 2011
Prednisolone tablets 2.5; 5, 10, 20, 25 mg
Dicloxacillin capsules [Opportunity for a buyer]
09 September 2011
Dicloxacillin capsules 250 & 500 mg
Flucloxacillin tablets [Opportunity for a buyer]
09 September 2011
Flucloxacillin tablets 500 & 750 mg
Warfarin tablets [Opportunity for a buyer]
11 August 2011
Warfarin tablets: 1-2, 5-3-5 mg
Ibuprofen tablets [Opportunity for a buyer]
11 August 2011
Ibuprofen filmcoated tablets 200, 400 & 600 mg
Paracetamol filmcoated tablets [Opportunity for a buyer]
14 January 2011
Paracetamol filmcoated tablets 500/650/1000 mg
Fusidic acid cream [Opportunity for a buyer]
21 December 2010
Fusidic acid 2 % cream with clinical studies
Xylometazoline nasal spray & nasal drops [Opportunity for a buyer]
21 December 2010
Xylometazoline nasal spray & nasal drops 0.5 & 1 mg/ml
Teicoplanine lyophylized powder for injection [Opportunity for a buyer]
20 December 2010
Teicoplanine lyophylized powder for injection 200 & 400 mg
Pantoprazole lyophylized powder for injection [Opportunity for a buyer]
20 December 2010
Pantoprazole lyophylized powder for injection 40 mg
Esomeprazole lyophylized powder for injection [Opportunity for a buyer]
20 December 2010
Esomeprazole lyophylized powder for injection 40 mg
Fluconazole solution for infusion in bags [Opportunity for a buyer]
20 December 2010
Fluconazole solution for infusion 100 mg/50 ml & 200 mg/100 & ml 400 mg/200 ml
Zoledronic acid solution for infusion [Opportunity for a buyer]
16 December 2010
Zoledronic acid solution for infusion 4 mg/5 ml & 5 mg/100 ml
Paracetamol solution for infusion [Opportunity for a buyer]
16 December 2010
Paracetamol solution for infusion 10 mg/ml available for licensing.

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Einar Geir Hreinsson, Vice-President Strategic Projects at Actavis, says:
"We used this channel to reach potential customers and it turned out to be considerably more effective than we had expected. It is invaluable to be able to introduce a new project like Opening Pharma in this way, through a single portal with connections in all directions. This will be our first choice the next time we want to give a new project a good promotion."

Rich DiCicco, Chief Executive Officer of Harvest Moon Pharma, comments:
"Harvest Moon Pharma has listed its complex generics and biosimilars on SourceGenerics for three years. We have received enquiries from 206 companies - including Pfizer, Sanofi, Teva, Stada, Ranbaxy and Sandoz - from 58 countries, and we are very pleased with the results. We intend to keep listing on SourceGenerics indefinitely."

Sanjiv Puri, Chief Executive Officer of Australia's Generic Partners, tells us:
"Within a week of posting our business opportunities on SourceGenerics we had received over 10 quality enquiries from leading generics companies throughout the world."

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