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Generic Tracleer (bosentan) Registration Submission: 16 May 2012 in Europe [Opportunity for a buyer]
06 January 2010
06 January 2010
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
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
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
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 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 (glatiramer acetate) Prefilled Syringes (PFS)Will be Ready for Filing in Regulated Markets in 4Q10. [Opportunity for a buyer]
04 January 2010
04 January 2010
Generic Copaxone PFS will be available to file as USA ANDA and EU MAA in eCTD in 2011.
Generic Venofer (iron sucrose) Vials for Registration Submissions: 2010 USA and 2011 in Europe [Opportunity for a buyer]
04 January 2010
04 January 2010
Generic Venofer vials: The ANDA will be filed in USA in 2010 and in Europe as MAA in eCTD in 2011.
The MAA dossier is ready to file.
Generic Xeloda (capecitabine) Tablets MAA for Europe: DCP Slot Feb 2010 [Opportunity for a buyer]
19 July 2009
19 July 2009
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.
Generic Alphagan P (brimonidine tartrate) 0.1% and 0.15% Opthalmic Solution Drops in 5, 10 and 15 ml [Opportunity for a buyer]
18 July 2009
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.
Generic Optivar (azalastine) 0.05% Opthalmic Solution Drops in 3 ml and 6 ml [Opportunity for a buyer]
18 July 2009
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.
Generic to Timoptic (timolol maleate) 0.5% Opthalmic Solution Drops [Opportunity for a buyer]
18 July 2009
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 otic 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 Cosopt (dorzolamide + timolol) 0.2%/0.5% Opthalmic Solution Drops [Opportunity for a buyer]
18 July 2009
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.
Generic to Trusopt (dorzolamide) 0.2% Opthalmic Solution Drops [Opportunity for a buyer]
18 July 2009
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.
Generic to Ciloxan (ciprofloxacin hcl) 0.3% Opthalmic Solution Drops [Opportunity for a buyer]
18 July 2009
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. The EU market is $ 10.4 million, and $ 88 million worldwide.
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.
High Titre Master Cell Bank for the production of BioSimilar Vectibix (panitumumab) for the treatment of colo-rectal cancer. [Opportunity for a buyer]
05 July 2009
05 July 2009
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.
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
This generic capsule is supplied in 100 mg strength.
Imiglucerase Injection Vials: Generic Product (and Biosimilar) to Cerezyme [Opportunity for a buyer]
27 June 2009
27 June 2009
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.
Buprenorphine + Naloxone SubLingual Tablets: A Generic Product to Suboxone [Opportunity for a buyer]
27 June 2009
27 June 2009
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.
Metoprolol Succinate ER Tablets: A Generic Product to Toprol XL [Opportunity for a buyer]
27 June 2009
27 June 2009
This extended release generic product is available in 25, 50, 100 and 200 mg strengths.
Carvedilol Phosphate Sustained Release Capsules: A Generic Product to Coreg CR [Opportunity for a buyer]
27 June 2009
27 June 2009
This controlled release carvedilol phosphate capsule generic product is available in 10, 20, 40 and 80 mg strengths.
Deferasirox Dispersable Tablets: for Oral Suspension: A Generic Product to Exjade [Opportunity for a buyer]
27 June 2009
27 June 2009
The oral dispersible tablets are available in 125, 250 and 500 mg strengths.
Etanercept Fusion Protein Cell Line: A Pedigreed Master Cell Bank for the Production of a Biosimilar to Enbrel [Opportunity for a buyer]
27 June 2009
27 June 2009
This cell line and process development scale up is completed, and is available with all of the cell-based assays. The pedigree is guaranteed
Rituximab Monoclonal Antibody Cell Line: A Pedigreed Master Cell Bank for the Production of a Biosimilar to Rituxan [Opportunity for a buyer]
27 June 2009
27 June 2009
This cell line and process development scale up is completed, and is available with all of the cell-based assays. The pedigree is guaranteed.
Bevacizumab Monoclonal Antibody Cell Line: A Pedigreed Master Cell Bank for the Production of a Biosimilar to Avastin [Opportunity for a buyer]
27 June 2009
27 June 2009
This cell line and process development scale up is completed, and is available with all of the cell-based assays. The pedigree is guaranteed.
Pentosan Polysulfate Sodium Capsules: A Generic Product to Elmiron [Opportunity for a buyer]
27 June 2009
27 June 2009
The capsule is available in 100 mgs.
This generic product is available in 100 and 400 mg. tablets. It is manufactured in an oncology inspected facility in Europe.
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
Extended Release Levetiracetam: A Generic Product to Keppra XR [Opportunity for a buyer]
27 June 2009
27 June 2009
This generic product is available in 500 and 750 mg. tablets
Once Daily Extended Release Methylphenidate: Generic Product to Concerta [Opportunity for a buyer]
27 June 2009
27 June 2009
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.
Cetuximab Pedigree Master Cell Bank for the Production of a Biosimilar to Erbitux [Opportunity for a buyer]
26 June 2009
26 June 2009
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.
Adalimumab Monoclonal Antibody Cell Line: A Pedigreed High Titre Master Cell Bank for the Production of a Biosimilar to Humira [Opportunity for a buyer]
26 June 2009
26 June 2009
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.
This generic product is available in 1,000, 2,000, 4,000 and 6,000 IU vials, and is launched in 7 countries.
This ketoprofen patch is launched in Japan and is available in 20 and 40 mgs strengths.
This generic patch contains 5% lidocaine (700 mgs) and is indicated for post-herpetic neuralgia (herpes zoster commonly known as shingles).
Zoledronic acid: a Generic Product to Zometa in two strengths: 4mg/ml (Zometa) and 5 mg/ 100 ml (Reclast or Aclasta) [Opportunity for a buyer]
26 June 2009
26 June 2009
Both EU MAAs are in eCTD format which can be filed as an ANDA in the USA.
Anastrazole: A Generic Product to Arimidex in a 1 mg. oral tablet [Opportunity for a buyer]
26 June 2009
26 June 2009
The MAA dossier is in eCTD format, and has a DCP running. It is registered in Denmark.
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 2011
Fluticasone + salmeterol DPI: Generic Product to Advair DISKUS and Seretide [Opportunity for a buyer]
26 June 2009
26 June 2009
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.
Enoxaparin generic product to Clexane and Lovenox With Clinical Studies [Opportunity for a buyer]
26 June 2009
26 June 2009
This enoxaparin generic product is registered in 11 countries and launched in three countries in 20, 40, 60 and 80 mgs strengths.
The EU CTD MAA of a non-infringing lyophilized generic Taxotere is offered, already launched and under registration in some countries.
The product is a 30-day depot formulation being developed as an EU CTD MAA.
Low Cost Piperacillin + Tazobactam MAA Dossier, ANDA and Supply [Opportunity for a buyer]
25 June 2009
25 June 2009
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.
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]
21 June 2009
21 June 2009
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.