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Alemtuzumab Monoclonal Antibody Cell Line and API: Biosimilar to Campath [Opportunity for a buyer]
02 September 2010
02 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
Golimumab Monoclonal Antibody Cell Line and API: Biosimilar to Simponi [Opportunity for a buyer]
02 September 2010
02 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
Tocilizumab Monoclonal Antibody Cell Line and API: Biosimilar to Actemra [Opportunity for a buyer]
02 September 2010
02 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
Abatacept Monoclonal Antibody Cell Line and API: Biosimilar to Orencia [Opportunity for a buyer]
02 September 2010
02 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
Ofatumumab Monoclonal Antibody Cell Line and API: Biosimilar to Arzerra [Opportunity for a buyer]
02 September 2010
02 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
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.
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.
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Adapalene is a third-generation topical retinoid primarily used in the treatment of mild-moderate acne and is also used to treat keratosis pilaris as well as other skin conditions.
Terbinafine hydrochloride is an antifungal medicine used to treat infections caused by fungi.
Mometasone is used to relieve the itching and inflammation of numerous skin conditions.
The combination of betamethasone and salicyclic acid in this medicine is used to treat dry, scaly, inflammatory skin disorders such as eczema and psoriasis, where the thickened skin could otherwise prevent absorption of the corticosteroid.
Risperidone is a novel antipsychotic belonging to a new class of antipsychotic agents, the benzisoxazole derivatives. It is indicated for the treatment of schizophrenia and other psychotic disorders. At low doses it is also used to treat behavioural disturbances in patients with dementia.
Quetiapine belongs to a new chemical class called dibenzothiazepine derivatives and its primary indications are adult schizophrenia and related psychoses in adults and the elderly
Letrozole is a potent and highly selective non-steroidal aromatase inhibitor and is used predominantly to treat breast cancer in post-menopausal women.
This product is indicated for the treatment of early and advanced prostate cancer
Anastrozole is a potent and highly selective non-steroidal aromatase inhibitor and is used predominantly to treat breast cancer in post-menopausal women
Generic Ziprasidone 20, 40, 60 & 80 mg tablets CTD dossier with Bioequivalence study against EU reference product available now for out-licensing
Ranibizumab Monoclonal Antibody Cell Line and API: Biosimilar to Lucentis [Opportunity for a buyer]
19 April 2010
19 April 2010
Updated on 02 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
Infliximab Monoclonal Antibody Cell Line and API: Biosimilar to Remicade [Opportunity for a buyer]
19 April 2010
19 April 2010
Updated on 02 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
Omalizumab Monoclonal Antibody Cell Line and API: Biosimilar to Xolair [Opportunity for a buyer]
19 April 2010
19 April 2010
Updated on 02 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
Palivizumab Monoclonal Antibody Cell Line and API: Biosimilar to Synagis [Opportunity for a buyer]
19 April 2010
19 April 2010
Updated on 02 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
Natlizumab Monoclonal Antibody Cell Line and API: Biosimilar to Tysabri [Opportunity for a buyer]
19 April 2010
19 April 2010
Updated on 02 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
Abciximab Monoclonal Antibody Cell Line and API: Biosimilar to ReoPro [Opportunity for a buyer]
19 April 2010
19 April 2010
Updated on 02 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
Trastuzumab Monoclonal Antibody Cell Line and/or API with Phase I pK/PD: A Biosimilar to Humira Produced in Europe Ready 3Q2011 [Opportunity for a buyer]
19 April 2010
19 April 2010
Updated on 02 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
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 an EU CTD MAA.
The product is being developed as an ANDA and as an EU CTD MAA.
The product is being developed as an ANDA and as an EU CTD MAA.
Generic Nateglinide 60 & 120 mg Film Tablets CTD dossier with Bioequivalence study against EU originator (Starlix® UK) available now for out-licensing
Generic Olopatadine 0.1% eye drops CTD dossier available now for out-licensing through a technology transfer model
Generic Mometasone Furoate 50 mcg nasal spray CTD dossier available now for out-licensing
Generic Metformin + Pioglitazone 850/15 mg tablets CTD dossier with Bioequivalence study against EU originator (Competact® UK) available now for out-licensing
Generic Lamivudine 100 mg Film Tablets CTD dossier with Bioequivalence study against EU originator (Zeffix® Germany) available now for out-licensing
Generic Rosuvastatin 5, 10, 20 & 40 mg CTD dossier with Bioequivalence study against EU originator (Crestor® UK) available now for out-licensing
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: Ready to File September 2010 with DCP Slot in Feb. 2011 [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 September 2010 and filed via the DCP pathway in Feb. 2011 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.
Panitumumab Monoclonal Antibody Cell Line and API: Biosimilar to Vectibix [Opportunity for a buyer]
05 July 2009
05 July 2009
Updated on 23 August 2010
Panitumumab is a fully human mAb produced in CHO cells targeting EGFR receptor with world sales in of $ 212 million as of March 31, 2010. It treats colon cancer.
Extremely Small and Thin Estradiol Patch: A Generic Product to Vivelle Dot [Opportunity for a buyer]
28 June 2009
28 June 2009
Updated on 01 September 2010
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
Updated on 02 September 2010
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 heroin addiction.
Metoprolol Succinate ER Tablets: A Generic Product to Toprol XL [Opportunity for a buyer]
27 June 2009
27 June 2009
Updated on 23 August 2010
This extended release generic product is available in 25, 50, 100 and 200 mg strengths.
Deferasirox Dispersable Tablets: for Oral Suspension: A Generic Product to Exjade [Opportunity for a buyer]
27 June 2009
27 June 2009
Updated on 01 September 2010
The oral dispersible tablets are available in 125, 250 and 500 mg strengths.
rh-TNFR-Fc Finished Product Approved and Launched: Biosimilar to Enbrel (etanercept) [Opportunity for a buyer]
27 June 2009
27 June 2009
Updated on 01 September 2010
A recombinant TNF Receptor II – Fc Fusion Protein (rhTNFR-Fc) biosimilar to Enbrel in 25 mgs 2 mL lyophilized glass vials has been approved and launched having an extensive clinical package.
Rituximab Monoclonal Antibody Cell Line and API: Biosimilar to Rituxan [Opportunity for a buyer]
27 June 2009
27 June 2009
Updated on 23 August 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
Bevacizumab Monoclonal Antibody Cell Line and API: Biosimilar to Avastin [Opportunity for a buyer]
27 June 2009
27 June 2009
Updated on 01 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order.
Imatinib Mesylate Tablets: A Generic Product to Gleevec [Opportunity for a buyer]
27 June 2009
27 June 2009
Updated on 01 September 2010
This generic product is available in 100 and 400 mg. tablets and available for license in Europe.
Oral Effervescent Buccal Tablet of Fentanyl: A Generic Product to Fentora [Opportunity for a buyer]
27 June 2009
27 June 2009
Updated on 01 September 2010
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 in the buccal cavity (above a rear molar, between the upper cheek and gum)
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 Launched in a Regulated Country [Opportunity for a buyer]
27 June 2009
27 June 2009
Updated on 01 September 2010
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 Monoclonal Antibody Cell Line and API: Biosimilar to Erbitux [Opportunity for a buyer]
26 June 2009
26 June 2009
Updated on 02 September 2010
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order
Adalimumab Monoclonal Antibody Cell Line and/or API with Phase I pK/PD: A Biosimilar to Humira Produced in Europe [Opportunity for a buyer]
26 June 2009
26 June 2009
This master cell bank is fully documented, with a high titre of 3 to 5 g/l expression; with stability according to EU requirements; with regulatory analytics; and, proof of comparability in animals: 15 months delivery from date of order.
This generic product is available in 1,000, 2,000, 4,000 and 6,000 IU vials, and is launched in 7 countries.
Zoledronic acid: a Generic Product 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 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
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 13 countries, launched in nine countries, and will be registered in three more countries in 2010 in 20, 40, 60 and 80 mgs strengths.
Lyophilized Docetaxel in Two Vials: a Generic Product to Taxotere [Opportunity for a buyer]
25 June 2009
25 June 2009
An EU CTD MAA of a non-infringing lyophilized generic Taxotere is offered, the DCP is running (RMS is UK) and will be completed August 2010.
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 for a generic form of Zosyn (Tazocin). MAs have been granted in Spain and Portugal. The dossier is available to file as an ANDA for 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 currently in an EU DCP clock stop, and will be approved soon. 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.