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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 660mg, 800mg, 1000mg
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 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 (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 4, 16 & 32 mg
Prednisolone tablets 2.5; 5, 10, 20, 25 mg
Dicloxacillin capsules 250 & 500 mg
Flucloxacillin tablets 500 & 750 mg
Warfarin tablets: 1-2, 5-3-5 mg
Ibuprofen filmcoated tablets 200, 400 & 600 mg
Standing (Granted) MA for Sale: Montelukast calcium 4 mg, 5 mg chewable tablets and 10 mg. coated tablets [Opportunity for a buyer]
13 April 2011
13 April 2011
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 .
Standing (Granted) MA for Sale: Risendronate Sodium 35 mg coated tablets [Opportunity for a buyer]
13 April 2011
13 April 2011
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 .
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)
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.
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
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.
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.
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.
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
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
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
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.
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
Biosimilar ReoPro is launched and available for license worldwide
Trastuzumab mAb API with Phase I pK/PD in EU Humans: A Biosimilar to Herceptin [Opportunity for a buyer]
14 March 2011
14 March 2011
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
The product is being developed as an ANDA and an EU CTD MAA.
This is an extended release injection product that is being developed as an ANDA and as an EU CTD MAA.
Generic Tracleer (bosentan) Registration Submission: 16 May 2012 in Europe [Opportunity for a buyer]
14 March 2011
14 March 2011
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).
BioBetter Avastin (bevacizumab) Registration to be filed in 2014 [Opportunity for a buyer]
14 March 2011
14 March 2011
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 (glatiramer acetate) Prefilled Syringes (PFS) Will be Ready for Filing in Regulated Markets in 2Q12. [Opportunity for a buyer]
14 March 2011
14 March 2011
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 (iron sucrose) Vials for Registration Submissions: 2010 USA and 2011 in Europe [Opportunity for a buyer]
14 March 2011
14 March 2011
Generic Venofer vials without clinical trials: Launched in two EU countries.
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.
Imiglucerase Injection Vials: Generic Product (and Biosimilar) to Cerezyme [Opportunity for a buyer]
14 March 2011
14 March 2011
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.
Deferasirox Dispersable Tablets: for Oral Suspension: A Generic Product to Exjade [Opportunity for a buyer]
14 March 2011
14 March 2011
The oral dispersible tablets are available in 125, 250 and 500 mg strengths.
Rituximab mAb API with Phase I pK/PD in EU Humans: A Biosimilar to Rituxan [Opportunity for a buyer]
14 March 2011
14 March 2011
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.
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
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
Once Daily Extended Release Methylphenidate: Generic Product to Concerta Launched in a Regulated Country [Opportunity for a buyer]
14 March 2011
14 March 2011
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.
Cetuximab mAb API with Phase I pK/PD in EU Humans: A Biosimilar to Erbitux [Opportunity for a buyer]
14 March 2011
14 March 2011
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
Adalimumab mAb API with Phase I pK/PD in EU Humans: A Biosimilar to Humira Produced in Europe [Opportunity for a buyer]
14 March 2011
14 March 2011
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
Zoledronic acid: a Generic Product in two strengths: 4mg/ml (Zometa) and 5 mg/ 100 ml (Reclast or Aclasta) [Opportunity for a buyer]
14 March 2011
14 March 2011
Both EU MAAs are in eCTD format which can be filed as an ANDA in the USA.
The product is a 30-day depot formulation being developed as an EU CTD MAA.
Seeking European Licensees for a PEGfilgrastim, a biosimilar to Neulasta in a 6 mg. PFS
Generic Tacrolimus Capsules with 90-110% Confidence Limits for BE Study [Opportunity for a buyer]
14 March 2011
14 March 2011
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 5.0 mg / 1ml
Tobramycin Nebules and eyedrops 60mg/ ml & 3mg/ ml
Sodium Cromoglycate unitdose eyedrops 20mg/ 1ml
Ketotifen unitdose eyedrops 0.25mg/ ml
Ipratropium unit dose vials for inhalation solution for inhalation, varius strengths. EU-CTD dossier ready
Diclofenac unitdose eyedrops 0,1% in 0,3 and 0,4 ml.
EU-CTD ready
Salbutamol/Ipratropium solution for inhalation 2.5 mg + 0.5 mg in 2.5 ml
Salbutamol unit dose vials for inhalation - solution for inhalation
Ofloxacin eyedrops, multidose and unitdose available for licensing.
Paracetamol filmcoated tablets 500/650/1000 mg
Fusidic acid 2 % cream with clinical studies
Xylometazoline nasal spray & nasal drops 0.5 & 1 mg/ml
Teicoplanine lyophylized powder for injection 200 & 400 mg
EU CTD.
Feb 2011 (bags)
August 2011 (amps)
EU CTD.
Pantoprazole lyophylized powder for injection 40 mg
Esomeprazole lyophylized powder for injection 40 mg
Fluconazole solution for infusion 100 mg/50 ml & 200 mg/100 & ml 400 mg/200 ml
Zoledronic acid solution for infusion 4 mg/5 ml & 5 mg/100 ml
Paracetamol solution for infusion 10 mg/ml available for licensing.
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 is an antineoplastic alkylating agent.
Samples and technical documents are available upon request.
Cefoxitin injection 1.2g;
EU CTD dossier available for out-licensing.
Cefpodoxime tablets 100mg & 200mg;
Cefpodoxime powder for oral suspension 40mg/5ml;
EU CTD dossiers available for out-licensing.
Cefprozil tablets 250mg & 500mg;
Cefprozil powder for 125mg/5ml & 250mg/5ml;
EU CTD dossiers available for out-licensing.
Ceftazidime powder for injection 250mg, 500mg, 1g, 2g & 3g;
EU CTD dossiers available for out-licensing.
Ceftriaxone powder for injection 250mg, 500mg & 1.2g;
EU CTD dossiers available for out-licensing.
Cefuroxime tablets & powder for injection EU CTD dossier available [Opportunity for a buyer]
14 October 2010
14 October 2010
Cefuroxime tablets 125mg, 250mg & 500mg;
Cefuroxime powder for injection 250mg, 750mg & 1.5g;
EU CTD dossiers available for out-licensing.
Clarithromycin tablets 250mg & 500mg;
EU CTD dossiers available for out-licensing.
Flucloxacillin injection 250mg, 500mg, 1g & 2g;
EU CTD dossiers available for out-licensing.
Fluconazole capsules 50mg, 100mg, 150mg, 200mg;
EU CTD dossiers available for out-licensing.
Terbinafine tablets 125mg & 250mg;
EU CTD dossiers available for out-licensing.
Valaciclovir tablets 500mg & 1000mg;
EU CTD dossiers available for out-licensing.
Zidovudine capsules 100mg & 250mg;
EU CTD dossiers available for out-licensing.
Risedronate tablets 5mg, 30mg, 35mg.
EU CTD dossier available.
Pantoprazole DR tablets 20mg, 40mg.
EU CTD dossier available.
Omeprazole DR capsules, 10mg, 20mg, 40mg.
EU CTD dossier available.
Ribavirin tablets 200mg.
Ribavirin capsules 200mg.
EU CTD dossier available.
Clindamycin capsules 150mg, 300mg.
EU CTD dossier available.
Didanosine DR capsules 200mg, 250mg, 400mg.
EU CTD dossier available.
Ropinirole tablets 0.25mg, 0.5mg, 1mg, 2mg, 5mg.
EU CTD dossier available.
Escitalopram tablets 5mg, 10mg, 15mg, 20mg.
CTD dossier available
Betahistine tablets 8mg, 16mg, 24mg.
CTD dossier available
Quinapril + HCTZ tablets 10+12.5mg, 20+12.5mg, 20+25mg;
EU CTD dossier available.
Soon available Quinapril HCl.
Trandolapril capsules 0.5mg, 1mg, 2mg, 4mg;
EU CTD dossier available.
Torasemide tablets 5mg, 10mg.
EU CTD dossier available.
Simvastatin tablets 5mg, 10mg, 20mg, 30mg, 40mg, 60mg, 80mg;
EU CTD dossier available.
Ramipril tablets 5mg, 10mg;
Ramipril capsules 1.25mg, 2.5mg, 5mg, 10mg;
EU CTD dossier available.
Perindopril tablets 2mg, 4mg, 8mg;
EU CTD dossier available
Losartan & Losartan HCTZ tablets, CTD dossiers available [Opportunity for a buyer]
01 September 2010
01 September 2010
Losartan tablets 25mg, 50mg, 100mg;
Losartan + HCTZ tablets 50+12.5mg & 100+25mg;
EU CTD dossiers available.
Lisinopril tablets 5mg, 10mg, 20mg, 30mg, 40mg;
EU CTD dossier available.
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
01 September 2010
Fosinopril tablets 10mg, 20mg;
Fosinopril HCTZ tablets 20+12.5mg & 10+12.5mg;
EU CTD dossiers available.
Doxazosin tablets 1mg, 2mg, 4mg, 8mg; EU CTD dossier available.
Clopidogrel tablets 75mg; EU CTD dossier available.
Carvedilol tablets 3.125mg 6.25mg, 12.5mg, 25mg; EU CTD dossier available.
Bisoprolol Fumarate tablets 1.25mg, 2.5mg, 3.75mg, 5mg, 7.5mg, 10mg. EU CTD dossier available
Amlodipine tablets 5mg & 10mg; Amlodipine capsules 5mg & 10mg; EU CTD dossiers available for out-licensing.
This generic product is launched in the USA, Canada and South Korea in 30, 60 and 90 mg. strengths
The MAA in CTD format will be filed in the EU with the asthma and COPD indications in 2012
Fluticasone + salmeterol DPI: Generic Product to Advair DISKUS and Seretide [Opportunity for a buyer]
26 June 2009
26 June 2009
This product is launched in the EU and is still available for license in some countries