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Paracetamol filmcoated tablets. 500/650/1000 mg [Opportunity for a buyer]
14 January 2011
Premium version, equivalent to GSK’s brand. EU-CTD ready June 2011

Bromazepam [Opportunity for a buyer]

10 January 2011
Bromazepam is a tranquilizer from the group of benzodiazepines. It is characterized by specific anti-anxiety effects and
used in medicine for the treatment of acute anxiety and as a sedative. The effect is based on its binding to GABA
receptors in the brain. Samples and technical documents are available upon request.

Codeine, Codeine Phosphate Hemihydrate [Opportunity for a buyer]

10 January 2011
Codeine, a phenanthrene derivative, is an opioid analgesic obtained from opium or made by methylating morphine. It is a
much less potent analgesic than morphine and has relatively mild sedative effects. Codeine, especially its phosphate salt,
is given orally in the form of linctuses for the relief of coughs and as tablets for the relief of mild to moderate pain, often in
combination with a non-opioid analgesic such as aspirin, ibuprofen or paracetamol. The phosphate is also administered
by intramuscular or subcutaneous injection for the relief of pain. Samples and technical documents (CEP) are available
upon request.

Ibandronate 150mg [Opportunity for a buyer]

07 January 2011
Presentation: 150mg

Paricalcitol vials/ampoules [Opportunity for a buyer]

07 January 2011
Presentation: - 2mcg/ml; 1 ml vials/ampoules - 5mcg/ml; 1 ml vials/ampoules - 10mcg/ml; 2ml vials/ampoules

Sevelamer HCI [Opportunity for a buyer]

07 January 2011
Presentation: 400mg, 800mg tablets

Montelukast sachets (UD), chewable tabs, tabs [Opportunity for a buyer]

07 January 2011
Presentation: sachets, chewable tablets, tablets.

Risedronate 75mg tabs (UD) [Opportunity for a buyer]

07 January 2011
presentation: 75mg tablets for osteoporosis treatment.

Fusidic acid 2 % [Opportunity for a buyer]

21 December 2010
EU CTD. DCP ongoing

Xylometazoline 0,05 & 0,1 mg/ml [Opportunity for a buyer]

21 December 2010
Ready, multiple MA’s.

Teicoplanine 200 & 400 mg [Opportunity for a buyer]

20 December 2010
EU CTD. DCP ongoing

Ropivacaine 2 mg/ml & 5 mg/ml & 7,5 mg/ml & 10 mg/ml [Opportunity for a buyer]
20 December 2010
Updated on 14 January 2011
EU CTD. Feb 2011 (bags) August 2011 (amps)

Remifentanyl 1mg & 2mg & 5mg [Opportunity for a buyer]

20 December 2010
Updated on 14 January 2011
EU CTD.

Pantoprazole 40mg [Opportunity for a buyer]

20 December 2010
Updated on 14 January 2011
EU CTD dossier available.
Esomeprazole 40mg [Opportunity for a buyer]
20 December 2010
Updated on 14 January 2011
EU CTD dossier available.

Fluconazole 100 mg/50 ml & 200 mg/100 & ml 400 mg/200 ml [Opportunity for a buyer]
20 December 2010
EU CTD.

Zoledronic acid 4 mg/5 ml & 5 mg/100 ml [Opportunity for a buyer]

16 December 2010
EU CTD and US dossier available.

Paracetamol solution for infusion 10 mg/ml [Opportunity for a buyer]

16 December 2010
Paracetamol solution IV available for licensing.

Pemetrexed [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.

Imatinib Mesilate [Opportunity for a buyer]

22 November 2010
Imatinib Mesilate is a tyrosine kinase inhibitor that inhibits the BCR-ABL tyrosine kinase created by the Philadelphia
chromosome abnormality in chronic myeloid and acute lymphoblastic leukemia. 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 & powder for injection EU CTD dossier available  [Opportunity for a buyer]
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 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.

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

Alemtuzumab Monoclonal Antibody Cell Line and API: Biosimilar to Campath [Opportunity for a buyer]
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
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
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
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
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, 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.

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.

Ziprasidone (CTD dossier) [Opportunity for a buyer]

23 April 2010
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
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
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
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
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
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
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
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

Fondaparinux: A Generic to Arixtra [Opportunity for a buyer]

19 April 2010
The product is being developed as an ANDA and an EU CTD MAA.

Risperidone Injectable Depot: A Generic to Risperdal Consta [Opportunity for a buyer]

19 April 2010
This is an extended release injection product that is being developed as an ANDA and an EU CTD MAA.

Meropenem: A Generic to Merrem IV [Opportunity for a buyer]

19 April 2010
The product is being developed as an ANDA and as an EU CTD MAA.

Imipenem + Cilastatin: A Generic to Primaxin IV [Opportunity for a buyer]

19 April 2010
The product is being developed as an ANDA and as an EU CTD MAA.

Nateglinide (CTD dossier) [Opportunity for a buyer]

12 March 2010
Generic Nateglinide 60 & 120 mg Film Tablets CTD dossier with Bioequivalence study against EU originator (Starlix® UK)
available now for out-licensing

Olopatadine eye drops (Technology Transfer) [Opportunity for a buyer]

12 March 2010
Generic Olopatadine 0.1% eye drops CTD dossier available now for out-licensing through a technology transfer model

Mometasone Furoate nasal spray (CTD dossier) [Opportunity for a buyer]

12 March 2010
Generic Mometasone Furoate 50 mcg nasal spray CTD dossier available now for out-licensing

Metformin + Pioglitazone (CTD dossier) [Opportunity for a buyer]

12 March 2010
Generic Metformin + Pioglitazone 850/15 mg tablets CTD dossier with Bioequivalence study against EU originator
(Competact® UK) available now for out-licensing

Lamivudine (CTD dossier) [Opportunity for a buyer]

12 March 2010
Generic Lamivudine 100 mg Film Tablets CTD dossier with Bioequivalence study against EU originator (Zeffix® Germany)
available now for out-licensing

Rosuvastatin (CTD dossier) [Opportunity for a buyer]

12 March 2010
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
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 (glatiramer acetate) Prefilled Syringes (PFS)Will be Ready for Filing in Regulated Markets in
4Q10. [Opportunity for a buyer]
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
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.

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
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
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.

Generic Optivar (azalastine) 0.05% Opthalmic Solution Drops in 3 ml and 6 ml [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.

Generic to Timoptic (timolol maleate) 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.

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.

Generic Cosopt (dorzolamide + timolol) 0.2%/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.

Generic to Trusopt (dorzolamide) 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.

Generic to Ciloxan (ciprofloxacin hcl) 0.3% 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. 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.

Panitumumab Monoclonal Antibody Cell Line and API: Biosimilar to Vectibix  [Opportunity for a buyer]
05 July 2009
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
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.

Imiglucerase Injection Vials: Generic Product (and Biosimilar) to Cerezyme [Opportunity for a buyer]
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
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
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
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
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
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
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
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
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
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
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
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
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.

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.

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
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
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 2012

Fluticasone + salmeterol DPI: Generic Product to Advair DISKUS and Seretide [Opportunity for a buyer]
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
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
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.

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.

Low Cost Piperacillin + Tazobactam MAA Dossier, ANDA and Supply [Opportunity for a buyer]
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.

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

Generic Tacrolimus Capsules with 90-110% Confidence Limits for BE Study [Opportunity for a buyer]
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.