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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).
Biosimilar Humira (adalimumab) registration to be filed in 2014 [Opportunity for a buyer]
06 January 2010
An adalimumab cell line has been scaled up and is currently in pre-clinical studies with monkeys (subcutaneous injection 180 days) which will be completed in early 2010.
BioBetter Erbitux (cituximab) Registration to be filed in 2014 [Opportunity for a buyer]
06 January 2010
The cetuximab cell line has been scaled up and is currently in pre-clinical studies with monkeys (subcutaneous injection 180 days) which will be completed in early 2010.
BioBetter Avastin (bevacizumab) Registration to be filed in 2014 [Opportunity for a buyer]
06 January 2010
Bevacizumab cell line has been scaled up and is currently in pre-clinical studies with monkeys (subcutaneous injection 180 days) which will be completed in early 2010.
Biosimilar Rituximab registration to be filed in 2014 [Opportunity for a buyer]
06 January 2010
Biosimilar rituximab has been scaled up and is currently in pre-clinical studies with monkeys (subcutaneous injection 180 days) which will be completed in early 2010.
Generic Copaxone PFS will be available to file as USA ANDA and EU MAA in eCTD in 2011.
Generic Venofer vials: The ANDA will be filed in USA in 2010 and in Europe as MAA in eCTD in 2011.
Generic Comtan (entacapone) 200 mg. tablets [Opportunity for a buyer]
19 July 2009
The MAA dossier is ready to file.
The dossier for 150 mg and 500 mg film coated tablets will be completed in December 2009 and filed via the DCP pathway in Feb. 2010 with Belgium as the RMS. We are backward integrated to the API.
This ANDA will be filed in the USA in 2010, however the dossier could be filed in the EU since this is an opthalmic solution.
Generic Betoptic (betaxolol) 0.5% Opthalmic Solution Drops [Opportunity for a buyer]
18 July 2009
This ANDA will be filed in the USA in 2010, however the dossier could be filed in the EU since this is an opthalmic solution.
This ANDA will be filed in the USA in 2010, however the dossier could be filed in the EU since this is an opthalmic solution.
This ANDA will be filed in the USA in 2009, however the dossier could be filed in the EU since this is an opthalmic solution.
Generic Floxin Otic Ear Drops (ofloxacin) [Opportunity for a buyer]
18 July 2009
This ANDA will be filed in the USA in 2009, however the dossier could be filed in the EU since this is an otic solution.
Generic Vigimox (moxifloxacin) 0.5% Opthalmic Solution Drops [Opportunity for a buyer]
18 July 2009
This ANDA will be filed in the USA in 2009, however the dossier could be filed in the EU since this is an opthalmic solution.
This ANDA will be filed in the USA in 2009, however the dossier could be filed in the EU since this is an opthalmic solution.
This ANDA will be filed in the USA in 2009, however the dossier could be filed in the EU since this is an opthalmic solution.
This ANDA will be filed in the USA in 2009, however the dossier could be filed in the EU since this is an opthalmic solution. The EU market is $ 10.4 million, and $ 88 million worldwide.
Generic Brimonidine Tartrate 0.2% Opthalmic Solution Drops [Opportunity for a buyer]
18 July 2009
This ANDA will be filed in the USA in 2009, however the dossier could be filed in the EU since this is an opthalmic solution.
We have a unique expression vector and selection system for mAb cell line development that provides for a high yielding MCB. Such high titres provide for smaller scale bioreactors for scale up. Panitumumab is a fully human mAb produced in CHO cells targeting EGFR receptor with world sales in 2008 of $135 million.
Estradiol Patch: A Generic Product to Vivelle Dot [Opportunity for a buyer]
28 June 2009
This estradiol transdermal patch is very small and thin, because it is a generic to Vivelle Dot 50 and Vivelle Dot 100. The strengths are 50 mcg and 100 mcg/day
Itraconazole Capsules: A Generic Product to Sporanox [Opportunity for a buyer]
27 June 2009
This generic capsule is supplied in 100 mg strength.
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.
This generic product is available in two strengths: 2 mgs. buprenorphine + 0.5 mgs naloxone; and, 8 mgs buprenorphine + 2 mgs naloxone. It is indicated for treatment of herion addiction.
This extended release generic product is available in 25, 50, 100 and 200 mg strengths.
This controlled release carvedilol phosphate capsule generic product is available in 10, 20, 40 and 80 mg strengths.
The oral dispersible tablets are available in 125, 250 and 500 mg strengths.
This cell line and process development scale up is completed, and is available with all of the cell-based assays. The pedigree is guaranteed
This cell line and process development scale up is completed, and is available with all of the cell-based assays. The pedigree is guaranteed.
This cell line and process development scale up is completed, and is available with all of the cell-based assays. The pedigree is guaranteed.
The capsule is available in 100 mgs.
Imatinib Mesylate Tablets: A Generic Product to Gleevec [Opportunity for a buyer]
27 June 2009
This generic product is available in 100 and 400 mg. tablets. It is manufactured in an oncology inspected facility in Europe.
Oral Thin Film of Fentanyl: A Generic Product to Fentora [Opportunity for a buyer]
27 June 2009
This generic product is available in 0.1, 0.2, 0.3, 0.4, 0.5 and 0.6 mgs. It is taste-masked and melts on the tongue
This generic product is available in 500 and 750 mg. tablets
This once-daily generic product treats attention deficit disorder (ADHD) and is available for license worldwide in 18, 27, 36 and 54 mg ER tablets, which are manufactured in a USA cGMP FDA-inspected facility.
This mAb cell line, process development scale up and tech package will be completed in December 2010 and will be available with all of the cell-based assays. The pedigree is guaranteed.
This mAb cell line, process development scale up and tech package will be completed in December 2010, and is available with all of the cell-based assays. The pedigree is guaranteed.
Epoetin (EPO): A Biosimilar Product to Eprex [Opportunity for a buyer]
26 June 2009
This generic product is available in 1,000, 2,000, 4,000 and 6,000 IU vials, and is launched in 7 countries.
Ketoprofen Patch: A Generic Product to Mohrus Tape [Opportunity for a buyer]
26 June 2009
This ketoprofen patch is launched in Japan and is available in 20 and 40 mgs strengths.
Lidocaine Patch: A Generic Product to Lidoderm and Versatis [Opportunity for a buyer]
26 June 2009
This generic patch contains 5% lidocaine (700 mgs) and is indicated for post-herpetic neuralgia (herpes zoster commonly known as shingles).
Both EU MAAs are in eCTD format which can be filed as an ANDA in the USA.
The MAA dossier is in eCTD format, and has a DCP running. It is registered in Denmark.
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 2011
This MAA in CTD format will be filed in the EU in 2011 for the indications of asthma and COPD. In the USA, the NDA will be filed in 2011 with the indication of asthma and COPD.
This enoxaparin generic product is registered in 11 countries and launched in three countries in 20, 40, 60 and 80 mgs strengths.
Lyophilized Docetaxel, a Generic Product to Taxotere [Opportunity for a buyer]
25 June 2009
The EU CTD MAA of a non-infringing lyophilized generic Taxotere is offered, already launched and under registration in some countries.
Octreotide LAR: A Generic to Sandostatin LAR [Opportunity for a buyer]
25 June 2009
The product is a 30-day depot formulation being developed as an EU CTD MAA.
A dossier has been completed for Europe in eCTD format. It has been filed in Germany, and has been approved in Spain and Portugal. Also an ANDA has been filed in the USA.
PEGfilgrastim Biosimilar to Neulasta [Opportunity for a buyer]
21 June 2009
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 is ready to file as a CTD MAA for Europe and countries recognizing the European CTD.

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