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Innovative drug & preparation registration agent

To supply customized service of advanced and difficult formulation introduction or technical transfer from all over the world. One-stop service from advanced formulation development, technical transfer to approval of APIs and joint review.

Over 20 years of experience in registration service of APIs, formulation and excipient in China. Professional registration team, scientific and rigorous quality control guarantee.The successful rate is far ahead of its peers.

On a basis of extensive Chinese customers, we have huge requirements of the most wanted APIs, formulation technologies, formulation and reference drugs.We are devoting to source overseas reliable partners.

Formulation Products Available for Technical Transfer

English Name	Dosage Form & Strength	Regulatory Status	Developable Market	Project Type
Mirabegron	Sustained release tablet：25mg、50mg	Approved by EU	All markets	Tech-transfer
Succinylcholine	Injection：20mg/ml	Under review in US-FDA	All markets	Tech-transfer
Glycopyrrolate	Injection：0.2mg/ml	Under review in US-FDA	All markets	Tech-transfer
Eribulin	Injection：1mg/2ml (0.5mg/ml)	Available for European and American markets	All markets	Tech-transfer
Osimertinib	Tablet：40mg、80mg	Available for European and American markets	All markets	Tech-transfer
Bivalirudin	Injection：250mg/vial Solution：250mg/50ml (5mg/ml) 、500mg/100ml (5mg/ml)	Available for European and American markets	All markets	Tech-transfer
Doxylamine succinate+Pyridoxine HCl	Sustained release tablet:10 mg	Filing in FDA	All markets	Tech-transfer
Tenofovir Alafenamide Fumarate	Tablet:25 mg	Filing in FDA	All markets	Tech-transfer
Tolvaptan	Tablet:15 & 30 mg	Filing in FDA	All markets	Tech-transfer
Dolutegravir;Lamivudine;Tenofovir Disoproxil Fumarate	Tablet: 50 & 300 mg	Filing in FDA	All markets	Tech-transfer
Pentoxifylline	Sustained release tablet：400mg	Approved by EU Approved by US-FDA	All markets	Tech-transfer
Esomeprazole Magnesium	Sustained release tablet：375mg;500mg Extended release capsules：20mg; 40mg	Approved by US-FDA	All markets	Tech-transfer
Voriconazole	Suspension：200mg/5ml Injection：200mg/vial Tablet：20mg；50mg	Filing in FDA	All markets	Tech-transfer
Dabigatran Etexilate Mesylate	Capsule：75mg,110mg,150mg	Filing in FDA	All markets	Tech-transfer
Sevelamer	Tablet：800mg Suspending Agent：2.4mg/packet、800mg/packet	Available for European and American markets	All markets	Tech-transfer

Formulation Products Available for License-in

English Name	Dosage Form & Strength	Regulatory Status	Developable Market	Project Type
Mirabegron	Sustained release tablet：25mg、50mg	Approved by EU	All markets	License-in
Abacavir Sulfate	Injection：20mg/ml， Tablet：300mg	Approved by US-FDA	All markets	License-in
Ritonavir	Tablet：100mg	Approved by US-FDA	All markets	License-in
Roflumilast	Tablet：500mg	Approved by US-FDA	All markets	License-in
Etomidate Injectable Emulsion	Injection：2mg/ml	Approved by EU Approved by US-FDA	All markets	License-in
Atazanavir Sulfate	Capsule：150mg	Approved by US-FDA	All markets	License-in
Colesevelam Hydrochloride Tablets	Tablet：625mg	Approved by US-FDA	All markets	License-in
Lurasidone Hydrochloride Tablets	Tablet：20mg、40mg、60mg、80mg	Approved by US-FDA	All markets	License-in
Teriflunomide Tablets	Tablet：7 mg 、14 mg	Approved by US-FDA	All markets	License-in
Pramipexole	Tablet：0.125mg、0.25mg、0.5mg、0.75mg、1mg、1.5mg	Approved by US-FDA	All markets	License-in
Efavirenz	Tablet：600mg	Approved by EU Approved by US-FDA	All markets	License-in
Fosaprepitant	Injection：115mg/10ml	Easy to register in China； Approved by US-FDA	All markets	License-in
Dofetilide	Tablet/Capsule：125mcg,250mcg,500mcg	Approved by US-FDA	All markets	License-in
Brivaracetam	Tablet：10 mg，25 mg，50 mg，75 mg，100 mg	Easy to register in China； Approved by US-FDA	All markets	License-in
Thiotepa	Injection：10mg/ml	Clinical research have done on the basis of original drugs； Approved by US-FDA	All markets	License-in
Bosutinib	Tablet：100 mg、400 mg、500 mg	Clinical research have done on the basis of original drugs； Approved by US-FDA	All markets	License-in
Linagliptin	Tablet,Sustained release tablet：5mg	Approved by US-FDA	All markets	License-in
metformin+linagliptin	Tablet,Sustained release tablet：2.5mg: 850mg	Approved by US-FDA	All markets	License-in
empagliflozin	Tablet：1g,10g,100g,1kg,10kg,100kg	Approved by US-FDA	All markets	License-in
Levosimendan Injection	Injection：5ml,12.5mg	Approved by EU	All markets	License-in
OSELTAMIVIR PHOSPHATE	Dry Suspension：6mg/ml	Approved by US-FDA	All markets	License-in
Iron sucrose injection	Injection：100mg/5ml	Approved by US-FDA	All markets	License-in
ESCITALOPRAM OXALATE	Oral Solution：5mg/5ml	Approved by EU Approved by US-FDA	All markets	License-in
Posaconazole	Injection：200 mg/5 ml	Approved by Eastern Europe	All markets	License-in
sugammadex sodium	Injection： 500mg/5ml；200mg/2ml	Filing in US-FDA	All markets	License-in
BILASTINE	Film coated tablet: 20mg	Filing completed in EU and US-FDA in the fourth quarter of 2020	All markets	License-in
RASAGILINE MESYLATE	Tablet：0.5mg,1mg	Approved by EU	All markets	License-in
Chloroquine Diphosphate	Tablet：250mg，500mg	Ready to list on US-FDA	All markets	License-in
Doxylamine succinate+Pyridoxine HCl	Sustained release tablet：10 mg	Filing in US-FDA	All markets	License-in
Tenofovir Alafenamide Fumarate	Tablet：25 mg	Filing in US-FDA	All markets	License-in
Tolvaptan	Tablet：15 and 30 mg	Filing in US-FDA	All markets	License-in
Dolutegravir;Lamivudine;Tenofovir Disoproxil Fumarate	Tablet：50 and 300 mg	Filing in US-FDA	All markets	License-in
Pentoxifylline	Sustained release tablet：400mg Injection：100mg/5ml;100mg/2ml	Approved by EU Approved by US-FDA	All markets	License-in
Azelaic Acid	GEL：15%	Approved by US-FDA	All markets	License-in
Calcipotriene	Cream;0.005% Ointment：0.005%	Approved by US-FDA	All markets	License-in
Clotrimazole and Betamethasone Dipropionate	Cream：1%	Approved by US-FDA	All markets	License-in
Lidocaine	Ointment：5%	Approved by US-FDA	All markets	License-in
Dabigatran Etexilate Capsules	Capsule：75mg,110mg,150mg	Approved by US-FDA	All markets	License-in
Ezetimibe simvastatin	Tablet：10mg，20mg，40mg，80mg	Approved by EU Approving in US-FDA	All markets	License-in
Cabazitaxel	Injection：60mg/1.5ml (40mg/ml)	Approving in US-FDA	All markets	License-in
Etonogestrel	Implant： 68mg Vaginal ring：0.12mg/24 Hours	Approved by EU	All markets	License-in
Deferasirox	Dispersible tablet: 90 mg, 180 mg, 360 mg	Approving in US-FDA	All markets	License-in
Ivabradine	Tablet:2.5mg、5mg、7.5 mg	Approved by EU	All markets	License-in
Ibandronate	Tablet：150 mg	Approved by EU	All markets	License-in
Dasatinib	Tablet： 20mg、 50mg、 70mg、80mg、100mg、140mg	Approved by EU	All markets	License-in
Chloroquine Diphosphate	Tablet：250mg	Approved by EU	All markets	License-in
Eplerenone	Tablet：25mg,50 mg	Approved by EU	All markets	License-in
Rasagiline	Tablet：1 mg	Approved by EU	All markets	License-in
Anagrelide	Capsule：0.5mg, 1 mg	Approved by EU	All markets	License-in
Bendamustine	Injection：25mg/vial, 100 mg/vial	Approved by EU	All markets	License-in
Erlotinib	Tablet：25mg,100 mg,150mg	Approved by EU	All markets	License-in
Sevelamer	Tablet：800mg Suspending Agent：2.4mg/packet、800mg/packet	Available for European and American markets	All markets	License-in