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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
Rasagiline [Opportunity for a buyer]
24 November 2011
Parkinson''s Disease causes a deficiency of dopamine in the brain. Possible therapies include the inhibition of dopamine metabolism in the brain caused by enzymes such as the so-called MAO inhibitors. MAO occurs as types A and B. Rasagilin is selectively for the B-form.
Fingolimod [Opportunity for a buyer]
24 November 2011
Fingolimod is the first currently available oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in multiple sclerosis (MS), offering patients an alternative to the injectable therapies. Fingolimod has proven to be more effective than the classic therapy with Interpherone beta-1a and it has therefore been approved by the FDA as the first-line therapy against MS. Samples and technical documents are available upon request.
Fluorouracil [Opportunity for a buyer]
24 November 2011
Fluorouracil (5-FU) is a pyrimidine analog which is used in the treatment of cancer. It is a suicide inhibitor and works through irreversible inhibition of thymidylate synthase. 5-FU is one of the oldest and most successful antineoplastics and has never been substituted by another drug. To the contrary, its sales volume is even increasing. Samples and technical documents are available upon request.
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
The MA is granted and available for purchase for Denmark , Finland , Romania , Austria , Netherlands. The MAA is pending (but expected to be granted by May-June 2011) in Italy , Spain , Sweden , Germany .
The MA has been granted and is available in Netherlands , Belgium , Denmark , Norway , Ireland and Sweden . It is pending (national phase) in Spain and France .
Noninfringing Thermostable Biosimilar Etanercept [Opportunity for a buyer]
25 March 2011
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)
Omalizumab mAb: Biosimilar to Xolair [Opportunity for a buyer]
15 March 2011
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 2013.
Golimumab mAb: Biosimilar to Simponi [Opportunity for a buyer]
15 March 2011
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]
15 March 2011
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.
Natlizumab mAb: Biosimilar to Tysabri [Opportunity for a buyer]
15 March 2011
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.
Alemtuzumab mAb: Biosimilar to Campath [Opportunity for a buyer]
15 March 2011
This API is highly similar to Campath 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 2Q of 2013.
Tocilizumab mAb: Biosimilar to Actemra [Opportunity for a buyer]
14 March 2011
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
Abatacept fusion protein: Biosimilar to Orencia [Opportunity for a buyer]
14 March 2011
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
Ofatumumab mAb: Biosimilar to Arzerra [Opportunity for a buyer]
14 March 2011
This API is highly similar to Arzerra 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 2015
Infliximab mAb: Biosimilar to Remicade [Opportunity for a buyer]
14 March 2011
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 2012.
Palivizumab mAb: Biosimilar to Synagis [Opportunity for a buyer]
14 March 2011
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
Abciximab mAb: Biosimilar ReoPro Launched [Opportunity for a buyer]
14 March 2011
Biosimilar ReoPro is launched and available for license worldwide
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 3Q2012
Fondaparinux: A Generic to Arixtra [Opportunity for a buyer]
14 March 2011
The product is being developed as an ANDA and an EU CTD MAA.
Risperdone Injectable Depot: A Generic to Risperdal Consta [Opportunity for a buyer]
14 March 2011
This is an extended release injection product that is being developed as an ANDA and as an EU CTD MAA.
Generic Tracleer (bosentan) tablets (62.5 and 125 mgs): The MAA in eCTD will be filed in Europe on May 16, 2012 (expiration of data exclusivity).
Bevacizumab cell line has been scaled up and has completed pre-clinical studies with monkeys (subcutaneous injection 180 days). Phase I in 50 patients has begun.
Generic Copaxone in PFS will be available to file as a USA ANDA and as a EU MAA in eCTD in the second quarter of 2012.
Generic Venofer vials without clinical trials: Launched in two EU countries.
Panitumumab mAb API: Biosimilar to Vectibix [Opportunity for a buyer]
14 March 2011
This API is highly similar to Vectibix 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 2Q2014.
This generic product will be filed as an NDA 505 (b)(1) in the USA and as a biosimilar in the EU presented in 200 and 400 IU lyophilized vials. It is indicated for the treatment of Gaucher’s Disease. The product is made via mamallian cells in an inspected facility.
The oral dispersible tablets are available in 125, 250 and 500 mg strengths.
This API is highly similar to Rituxan 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 2Q2012.
Bevacizumab mAb API: Biosimilar to Avastin [Opportunity for a buyer]
14 March 2011
This API is highly similar to Avastin 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 2013
Imatinib Mesylate Capsules: A Generic Product to Gleevec [Opportunity for a buyer]
14 March 2011
This generic product is available in 100 and 400 mg. capsules and available for license in Europe and other countries accepting a non-infringing capsule
This once-daily generic product treats attention deficit disorder (ADHD) and is available for license in Europe which can be filed within six months of signing a contract. It is manufactured in an EU cGMP inspected facility. It is launched in a regulated country and has a CPP.
This API is highly similar to Erbitux 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
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 2012
Both EU MAAs are in eCTD format which can be filed as an ANDA in the USA.
Octreotide LAR: A Generic to Sandostatin LAR [Opportunity for a buyer]
14 March 2011
The product is a 30-day depot formulation being developed as an EU CTD MAA.
PEGfilgrastim Biosimilar to Neulasta [Opportunity for a buyer]
14 March 2011
Seeking European Licensees for a PEGfilgrastim, a biosimilar to Neulasta in a 6 mg. PFS
These generic tacrolimus capsules with an eCTD dossier are reformulated to meet the new confidence limits of 90-110% required by the MEB in Europe. The dossier has been approved in Gernamy and Austria and has a CPP. 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.
Tropicamid Eyedrops unit- and multidose [Opportunity for a buyer]
23 February 2011
Tropicamid Eyedrops unit- and multidose 5.0 mg / 1ml
Tobramycin Nebules and eyedrops [Opportunity for a buyer]
23 February 2011
Tobramycin Nebules and eyedrops 60mg/ ml & 3mg/ ml
Sodium Cromoglycate eyedrops [Opportunity for a buyer]
23 February 2011
Sodium Cromoglycate unitdose eyedrops 20mg/ 1ml
Ketotifen eyedrops [Opportunity for a buyer]
23 February 2011
Ketotifen unitdose eyedrops 0.25mg/ ml
Ipratropium unit dose vials for inhalation [Opportunity for a buyer]
22 February 2011
Ipratropium unit dose vials for inhalation solution for inhalation, varius strengths. EU-CTD dossier ready
Diclofenac unitdose eyedrops 0,1% [Opportunity for a buyer]
22 February 2011
Diclofenac unitdose eyedrops 0,1% in 0,3 and 0,4 ml. EU-CTD ready
Salbutamol/Ipratropium unit dose vials for inhalation [Opportunity for a buyer]
22 February 2011
Salbutamol/Ipratropium solution for inhalation 2.5 mg + 0.5 mg in 2.5 ml
Salbutamol unit dose vials for inhalation [Opportunity for a buyer]
22 February 2011
Salbutamol unit dose vials for inhalation - solution for inhalation
Ofloxacin eyedrops [Opportunity for a buyer]
22 February 2011
Ofloxacin eyedrops, multidose and unitdose available for licensing.
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
Ropivacaine 2 mg/ml & 5 mg/ml & 7,5 mg/ml & 10 mg/ml [Opportunity for a buyer]
20 December 2010
EU CTD. Feb 2011 (bags) August 2011 (amps)
Remifentanyl 1mg & 2mg & 5mg [Opportunity for a buyer]
20 December 2010
EU CTD.
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.
Pemetrexed Disodium [Opportunity for a buyer]
22 November 2010
Pemetrexed is a chemotherapy drug (multitargeted antifolate) for the treatment of non-small cell lung cancer (NSCLC) and pleural mesothelioma. Samples and technical documents are available upon request.
Bendamustine Hydrochloride [Opportunity for a buyer]
22 November 2010
Bendamustine Hydrochloride is an antineoplastic alkylating agent. Samples and technical documents are available upon request.
Cefoxitin injection EU CTD dossier available [Opportunity for a buyer]
14 October 2010
Cefoxitin injection 1.2g; EU CTD dossier available for out-licensing.
Cefpodoxime tablets & suspension EU CTD dossier available [Opportunity for a buyer]
14 October 2010
Cefpodoxime tablets 100mg & 200mg; Cefpodoxime powder for oral suspension 40mg/5ml; EU CTD dossiers available for out-licensing.
Cefprozil tablets & suspension EU CTD dossier available [Opportunity for a buyer]
14 October 2010
Cefprozil tablets 250mg & 500mg; Cefprozil powder for 125mg/5ml & 250mg/5ml; EU CTD dossiers available for out-licensing.
Ceftazidime powder for injection EU CTD dossier available [Opportunity for a buyer]
14 October 2010
Ceftazidime powder for injection 250mg, 500mg, 1g, 2g & 3g; EU CTD dossiers available for out-licensing.
Ceftriaxone powder for injection EU CTD dossier available [Opportunity for a buyer]
14 October 2010
Ceftriaxone powder for injection 250mg, 500mg & 1.2g; EU CTD dossiers available for out-licensing.
Cefuroxime tablets 125mg, 250mg & 500mg; Cefuroxime powder for injection 250mg, 750mg & 1.5g; EU CTD dossiers available for out-licensing.
Clarithromycin tablets EU CTD dossier available [Opportunity for a buyer]
14 October 2010
Clarithromycin tablets 250mg & 500mg; EU CTD dossiers available for out-licensing.
Flucloxacillin injection EU CTD dossier available [Opportunity for a buyer]
14 October 2010
Flucloxacillin injection 250mg, 500mg, 1g & 2g; EU CTD dossiers available for out-licensing.
Fluconazole capsules EU CTD dossier available [Opportunity for a buyer]
14 October 2010
Fluconazole capsules 50mg, 100mg, 150mg, 200mg; EU CTD dossiers available for out-licensing.
Terbinafine tablets EU CTD dossier available [Opportunity for a buyer]
14 October 2010
Terbinafine tablets 125mg & 250mg; EU CTD dossiers available for out-licensing.
Valaciclovir tablets EU CTD dossier available [Opportunity for a buyer]
14 October 2010
Valaciclovir tablets 500mg & 1000mg; EU CTD dossiers available for out-licensing.
Zidovudine capsules EU CTD dossier available [Opportunity for a buyer]
14 October 2010
Zidovudine capsules 100mg & 250mg; EU CTD dossiers available for out-licensing.
Risedronate tablets, CTD dossier available [Opportunity for a buyer]
23 September 2010
Risedronate tablets 5mg, 30mg, 35mg. EU CTD dossier available.
Pantoprazole tablets, CTD dossier available [Opportunity for a buyer]
23 September 2010
Pantoprazole DR tablets 20mg, 40mg. EU CTD dossier available.
Omeprazole capsules, CTD dossier available [Opportunity for a buyer]
23 September 2010
Omeprazole DR capsules, 10mg, 20mg, 40mg. EU CTD dossier available.
Ribavirin tablets & capsules, CTD dossier available [Opportunity for a buyer]
23 September 2010
Ribavirin tablets 200mg. Ribavirin capsules 200mg. EU CTD dossier available.
Clindamycin capsules, CTD dossier available [Opportunity for a buyer]
23 September 2010
Clindamycin capsules 150mg, 300mg. EU CTD dossier available.
Didanosine capsules, CTD dossier available [Opportunity for a buyer]
23 September 2010
Didanosine DR capsules 200mg, 250mg, 400mg. EU CTD dossier available.
Ropinirole tablets, CTD dossier available [Opportunity for a buyer]
23 September 2010
Ropinirole tablets 0.25mg, 0.5mg, 1mg, 2mg, 5mg. EU CTD dossier available.
Escitalopram tablets, CTD dossier available [Opportunity for a buyer]
23 September 2010
Escitalopram tablets 5mg, 10mg, 15mg, 20mg. CTD dossier available
Betahistine tablets, CTD dossier available [Opportunity for a buyer]
23 September 2010
Betahistine tablets 8mg, 16mg, 24mg. CTD dossier available
Quinapril HCTZ tablets, CTD dossier available [Opportunity for a buyer]
01 September 2010
Quinapril + HCTZ tablets 10+12.5mg, 20+12.5mg, 20+25mg; EU CTD dossier available. Soon available Quinapril HCl.
Trandolapril capsules, CTD dossier available [Opportunity for a buyer]
01 September 2010
Trandolapril capsules 0.5mg, 1mg, 2mg, 4mg; EU CTD dossier available.
Torasemide tablets, CTD dossier available [Opportunity for a buyer]
01 September 2010
Torasemide tablets 5mg, 10mg. EU CTD dossier available.
Simvastatin tablets, CTD dossier available [Opportunity for a buyer]
01 September 2010
Simvastatin tablets 5mg, 10mg, 20mg, 30mg, 40mg, 60mg, 80mg; EU CTD dossier available.
Ramipril tablets & capsules, CTD dossier available [Opportunity for a buyer]
01 September 2010
Ramipril tablets 5mg, 10mg; Ramipril capsules 1.25mg, 2.5mg, 5mg, 10mg; EU CTD dossier available.
Perindopril tablets, CTD dossier available [Opportunity for a buyer]
01 September 2010
Perindopril tablets 2mg, 4mg, 8mg; EU CTD dossier available
Losartan & Losartan HCTZ tablets, CTD dossiers available [Opportunity for a buyer]
01 September 2010
Losartan tablets 25mg, 50mg, 100mg; Losartan + HCTZ tablets 50+12.5mg & 100+25mg; EU CTD dossiers available.
Lisinopril tablets, CTD dossier available [Opportunity for a buyer]
01 September 2010
Lisinopril tablets 5mg, 10mg, 20mg, 30mg, 40mg; EU CTD dossier available.
Irbesartan tablets, CTD dossier available [Opportunity for a buyer]
01 September 2010
Irbesartan tablets 75mg, 150mg, 300mg; EU CTD dossier available Soon available Irbesartan HCTZ.
Fosinopril & Fosinopril HCTZ tablets, CTD dossier available [Opportunity for a buyer]
01 September 2010
Fosinopril tablets 10mg, 20mg; Fosinopril HCTZ tablets 20+12.5mg & 10+12.5mg; EU CTD dossiers available.
Doxazosin tablets, CTD dossier available [Opportunity for a buyer]
01 September 2010
Doxazosin tablets 1mg, 2mg, 4mg, 8mg; EU CTD dossier available.
Clopidogrel tablets, CTD dossier available [Opportunity for a buyer]
01 September 2010
Clopidogrel tablets 75mg; EU CTD dossier available.
Carvedilol tablets, EU CTD dossier available [Opportunity for a buyer]
01 September 2010
Carvedilol tablets 3.125mg 6.25mg, 12.5mg, 25mg; EU CTD dossier available.
Bisoprolol tablets, EU CTD dossier available [Opportunity for a buyer]
01 September 2010
Bisoprolol Fumarate tablets 1.25mg, 2.5mg, 3.75mg, 5mg, 7.5mg, 10mg. EU CTD dossier available
Amlodipine tablets & capsules EU CTD dossier available [Opportunity for a buyer]
01 September 2010
Amlodipine tablets 5mg & 10mg; Amlodipine capsules 5mg & 10mg; EU CTD dossiers available for out-licensing.
Nifedipine XL: A Generic Product to Procardia XL; Adalat XL [Opportunity for a buyer]
26 June 2009
This generic product is launched in the USA, Canada and South Korea in 30, 60 and 90 mg. strengths
Formoterol + budesonide DPI: A Generic Product to Symbicort [Opportunity for a buyer]
26 June 2009
The MAA in CTD format will be filed in the EU with the asthma and COPD indications in 2012
This product is launched in the EU and is still available for license in some countries

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