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桐晖药业是一家为医药研究提供专业服务的CRO公司
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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 NameDosage Form & StrengthRegulatory StatusDevelopable MarketProject Type
MirabegronSustained release tablet:25mg、50mgApproved by EUAll marketsTech-transfer
SuccinylcholineInjection:20mg/mlUnder review in US-FDAAll marketsTech-transfer
GlycopyrrolateInjection:0.2mg/mlUnder review in US-FDAAll marketsTech-transfer
EribulinInjection:1mg/2ml (0.5mg/ml)Available for European and American marketsAll marketsTech-transfer
OsimertinibTablet:40mg、80mgAvailable for European and American marketsAll marketsTech-transfer
BivalirudinInjection:250mg/vial
Solution:250mg/50ml (5mg/ml) 、500mg/100ml (5mg/ml)
Available for European and American marketsAll marketsTech-transfer
Doxylamine succinate+Pyridoxine HClSustained release tablet:10 mgFiling in FDAAll marketsTech-transfer
Tenofovir Alafenamide FumarateTablet:25 mgFiling in FDAAll marketsTech-transfer
TolvaptanTablet:15 & 30 mgFiling in FDAAll marketsTech-transfer
Dolutegravir;Lamivudine;Tenofovir Disoproxil FumarateTablet: 50 & 300 mgFiling in FDAAll marketsTech-transfer
PentoxifyllineSustained release tablet:400mgApproved by EU
Approved by US-FDA
All marketsTech-transfer
Esomeprazole MagnesiumSustained release tablet:375mg;500mg
Extended release capsules:20mg; 40mg
Approved by US-FDAAll marketsTech-transfer
VoriconazoleSuspension:200mg/5ml
Injection:200mg/vial
Tablet:20mg;50mg
Filing in FDAAll marketsTech-transfer
Dabigatran Etexilate MesylateCapsule:75mg,110mg,150mgFiling in FDAAll marketsTech-transfer
SevelamerTablet:800mg
Suspending Agent:2.4mg/packet、800mg/packet
Available for European and American marketsAll marketsTech-transfer



Formulation Products Available for License-in

English NameDosage Form & StrengthRegulatory StatusDevelopable MarketProject Type
MirabegronSustained release tablet:25mg、50mgApproved by EUAll marketsLicense-in
Abacavir SulfateInjection:20mg/ml,
Tablet:300mg
Approved by US-FDAAll marketsLicense-in
RitonavirTablet:100mgApproved by US-FDAAll marketsLicense-in
RoflumilastTablet:500mgApproved by US-FDAAll marketsLicense-in
Etomidate Injectable EmulsionInjection:2mg/mlApproved by EU
Approved by US-FDA
All marketsLicense-in
Atazanavir SulfateCapsule:150mgApproved by US-FDAAll marketsLicense-in
Colesevelam Hydrochloride TabletsTablet:625mgApproved by US-FDAAll marketsLicense-in
Lurasidone Hydrochloride TabletsTablet:20mg、40mg、60mg、80mgApproved by US-FDAAll marketsLicense-in
Teriflunomide TabletsTablet:7 mg 、14 mgApproved by US-FDAAll marketsLicense-in
PramipexoleTablet:0.125mg、0.25mg、0.5mg、0.75mg、1mg、1.5mgApproved by US-FDAAll marketsLicense-in
EfavirenzTablet:600mgApproved by EU
Approved by US-FDA
All marketsLicense-in
FosaprepitantInjection:115mg/10mlEasy to register in China;
Approved by US-FDA
All marketsLicense-in
DofetilideTablet/Capsule:125mcg,250mcg,500mcgApproved by US-FDAAll marketsLicense-in
BrivaracetamTablet:10 mg,25 mg,50 mg,75 mg,100 mgEasy to register in China;
Approved by US-FDA
All marketsLicense-in
ThiotepaInjection:10mg/mlClinical research have done on the basis of original drugs;
Approved by US-FDA
All marketsLicense-in
BosutinibTablet:100 mg、400 mg、500 mgClinical research have done on the basis of original drugs;
Approved by US-FDA
All marketsLicense-in
LinagliptinTablet,Sustained release tablet:5mgApproved by US-FDAAll marketsLicense-in
metformin+linagliptinTablet,Sustained release tablet:2.5mg: 850mgApproved by US-FDAAll marketsLicense-in
empagliflozinTablet:1g,10g,100g,1kg,10kg,100kgApproved by US-FDAAll marketsLicense-in
Levosimendan InjectionInjection:5ml,12.5mgApproved by EUAll marketsLicense-in
OSELTAMIVIR PHOSPHATEDry Suspension:6mg/mlApproved by US-FDAAll marketsLicense-in
Iron sucrose injectionInjection:100mg/5mlApproved by US-FDAAll marketsLicense-in
ESCITALOPRAM OXALATEOral Solution:5mg/5mlApproved by EU
Approved by US-FDA
All marketsLicense-in
PosaconazoleInjection:200 mg/5 mlApproved by Eastern EuropeAll marketsLicense-in
sugammadex sodiumInjection: 500mg/5ml;200mg/2mlFiling in US-FDAAll marketsLicense-in
BILASTINEFilm coated tablet: 20mgFiling completed in EU and US-FDA in the fourth quarter of 2020All marketsLicense-in
RASAGILINE MESYLATETablet:0.5mg,1mgApproved by EUAll marketsLicense-in
Chloroquine DiphosphateTablet:250mg,500mgReady to list on US-FDAAll marketsLicense-in
Doxylamine succinate+Pyridoxine HClSustained release tablet:10 mgFiling in US-FDAAll marketsLicense-in
Tenofovir Alafenamide FumarateTablet:25 mgFiling in US-FDAAll marketsLicense-in
TolvaptanTablet:15 and 30 mgFiling in US-FDAAll marketsLicense-in
Dolutegravir;Lamivudine;Tenofovir Disoproxil FumarateTablet:50 and 300 mgFiling in US-FDAAll marketsLicense-in
PentoxifyllineSustained release tablet:400mg
Injection:100mg/5ml;100mg/2ml
Approved by EU
Approved by US-FDA
All marketsLicense-in
Azelaic AcidGEL:15%Approved by US-FDAAll marketsLicense-in
CalcipotrieneCream;0.005%
Ointment:0.005%
Approved by US-FDAAll marketsLicense-in
Clotrimazole and Betamethasone DipropionateCream:1%Approved by US-FDAAll marketsLicense-in
LidocaineOintment:5%Approved by US-FDAAll marketsLicense-in
Dabigatran Etexilate CapsulesCapsule:75mg,110mg,150mgApproved by US-FDAAll marketsLicense-in
Ezetimibe simvastatinTablet:10mg,20mg,40mg,80mgApproved by EU
Approving in US-FDA
All marketsLicense-in
CabazitaxelInjection:60mg/1.5ml (40mg/ml)Approving in US-FDAAll marketsLicense-in
EtonogestrelImplant: 68mg
Vaginal ring:0.12mg/24 Hours
Approved by EUAll marketsLicense-in
DeferasiroxDispersible tablet: 90 mg, 180 mg, 360 mgApproving in US-FDAAll marketsLicense-in
IvabradineTablet:2.5mg、5mg、7.5 mgApproved by EUAll marketsLicense-in
IbandronateTablet:150 mgApproved by EUAll marketsLicense-in
DasatinibTablet: 20mg、 50mg、 70mg、80mg、100mg、140mgApproved by EUAll marketsLicense-in
Chloroquine DiphosphateTablet:250mgApproved by EUAll marketsLicense-in
EplerenoneTablet:25mg,50 mgApproved by EUAll marketsLicense-in
RasagilineTablet:1 mgApproved by EUAll marketsLicense-in
AnagrelideCapsule:0.5mg, 1 mgApproved by EUAll marketsLicense-in
BendamustineInjection:25mg/vial, 100 mg/vialApproved by EUAll marketsLicense-in
ErlotinibTablet:25mg,100 mg,150mgApproved by EUAll marketsLicense-in
SevelamerTablet:800mg
Suspending Agent:2.4mg/packet、800mg/packet
Available for European and American marketsAll marketsLicense-in


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