
Category | Drug products | Strength | Marketing Authorisations |
---|---|---|---|
Oncology | Gemcitabine HCl for Injection | 0.2g, 1.0g | Approved by FDA |
US dossier | |||
Irinotecan Hydrochloride Injection | 40 mg/2ml | Approved by FDA | |
100 mg/5ml | US dossier | ||
Oxaliplatin | 50 mg/vial | Approved by EU | |
Powder for Solution for Infusion | 100 mg/vial | EU dossier | |
Vinorelbine Tartrate Injection | 1ml:10mg | Approved by FDA | |
US dossier | |||
Cyclophosphamide Injection | 500 mg, 1 g, 2 g | Registration | |
US dossier | |||
Docetaxel Injection (two-vial) | 20 mg/0.5ml | Registration | |
US dossier | |||
Letrozole Tablets | 2.5 mg | Registration | |
US dossier | |||
Letrozole Film-Coated Tablets | 2.5 mg | Registration | |
EU dossier | |||
Oxaliplatin Injection | 50 mg/10ml | Registration | |
100 mg/20ml | US dossier | ||
Capecitabine Tablets | 0.15g; 0.50g | Approved by FDA | |
US dossier | |||
Pemetrexed Disodium for injection | 0.2g, | Dossier ready | |
CHINA dossier | |||
Etoposide Injection | 100ng/5ml | Dossier preparation | |
US/ANDA | |||
Cisplatin Injection | 6ml:30mg | Approved | |
2ml : 10 mg | CHINA dossier | ||
Decitabine for Injection | 50mg | Registration | |
CHINA dossier | |||
Imatinib Mesylate Tablets | 100mg,400mg | Registration | |
CHINA dossier | |||
Temozolomide for Injection | 100mg | Registration | |
CHINA dossier | |||
Mesna Injection | 2ml:0.2g; 4ml:0.4g | Approved by SFDA | |
CHINA dossier | |||
Methotrexate for Injection | 5mg; 0.1g; 1g | Approved by SFDA | |
Injection(Lyophilized) | CHINA dossier | ||
Hyponatremia | Tolvaptan Tablets | 15mg | Dossier preparation |
30mg | US/ANDA | ||
Anti-Hypertension | Irbesartan Tablets | 75, 150, 300mg | Approved by EU |
EU dossier | |||
Irbesartan Hydrochlorothiazide | 150/12.5, 300/25mg. | Approved by EU | |
Tablets | 300/12.5mg | EU dossier | |
Valsartan Tablets | 40, 80, 160 ,320 mg | Approved by EU | |
EU dossier | |||
Valsartan Hydrochlorothiazide | 80/12.5,160 /12.5mg, | Approved by EU | |
Tablets | 160/25, 320/25, 320/12.5mg | EU dossier | |
Candesartan ciexetil tablets | 2, 4, 8, 16, 32mg | Registration | |
CHINA dossier | |||
Candesartan ciexetil | 8/12.5mg, 16/12.5mg, 32/12.5mg, 32/25mg | Registration | |
CHINA dossier | |||
Telmisartan Tablets | 20mg,40mg,80mg | Registration | |
40/12.5mg, | CHINA dossier | ||
Telmisartan Hydrochlorothiazide Tab | 80/12.5mg,80/25mg | Dossier preparation | |
Antipsychotic | Duloxetine Hydrochloride Capsules | 20mg, 30mg,60mg | Registration |
US submitted | |||
Olanzapine Tablets | 5mg, 10mg | Dossier preparation | |
US/ANDA | |||
Aripiprazole Tablets | 2, 5 , 10, 15, 20, 30 mg | Dossier preparation | |
EU dossier | |||
Aripiprazole ODT | 5 , 10, 15, 20, 30 mg | Dossier preparation | |
EU dossier | |||
Aripiprazole Injection | 9.75mg/1.3ml | Registration | |
CHINA dossier | |||
Agomelatine Tablet | 25mg | Registration | |
CHINA dossier | |||
Desvenlafaxine Hydrochloride Tablets | 50mg, 100mg | Registration | |
CHINA dossier | |||
Escitalopram Oxalate Tablets | 5mg,10mg,20mg | Registration | |
CHINA dossier | |||
Iloperidone Tablets | 1mg,2mg,4mg,6mg | Registration | |
8mg,10mg,12mg | CHINA dossier | ||
Lurasidone HCl Tablets | 40mg,80mg | Registration | |
CHINA dossier | |||
Zolpidem Tartrate Tablets | 5mg | Registration | |
CHINA dossier | |||
Anticonvulsant | Gabapentin | 100 mg, 300 mg, 400 mg | Approved by FDA |
Capsules | US dossier | ||
Pregabalin Capsule | 25,50,75,100,150, | Dossier preparation | |
200,225,300 mg | EU Dossier | ||
Pregabalin Sustained Release Tablets | 82.5mg, 165mg, 330mg | Dossier preparation | |
CHINA dossier | |||
Pregabalin Oral Solution | 100ml:2g | Dossier preparation | |
CHINA dossier | |||
Anti-Alzheimer's | Donepezil Hydrochloride | 5mg | Approved by EU |
Film-coated tablets | 10mg | EU dossier | |
Donepezil Hydrochloride Tablets | 5mg | Approved by SFDA | |
CHINA dossier | |||
Muscle relaxant | Cisatracurium Besylate for injection | 10 mg | Registration |
EU/DCP Dec.2012 | |||
Atracurium Besilate for Injection | 10mg; 25mg | Approved by SFDA | |
China dossier | |||
Antibiotic | Tigecycline for injection | 50mg | Registration |
CHINA dossier | |||
Linezolid Tablets | 600mg | Registration | |
CHINA dossier | |||
Daptomycin for injection | 0.5g | Registration | |
CHINA dossier | |||
Moxifloxacin Hydrochloride Injection | 250ml: 0.4g | Dossier preparation | |
CHINA dossier | |||
Meropenem for injection | 0.5 g, 1.0 g | Approved by Russia MOH ACTD dossier | |
0.25g . 1.0g | Approved by SFDA China dossier | ||
Clarithromycin Tablets | 50mg; 0.125g; 0.25g | Approved by SFDA | |
China dossier | |||
Clarithromycin | 0.5g | Approved by SFDA | |
Sustained Release Tablets | China dossier | ||
Levofloxacin HCl Tablets | 0.1g; 0.5g | Approved by SFDA | |
China dossier | |||
Roxithromycin Capsules | 0.15g | Approved by SFDA | |
China dossier | |||
Roxithromycin Dispersible Tablets | 0.15g | Approved by SFDA | |
China dossier | |||
hypolipidemic | Atovastatin Calcium Tablets | 10mg | Registration |
CHINA dossier | |||
Rosuvastatin Calcium Dispersible Tablets | Registration | ||
CHINA dossier | |||
Antiulcer | Dexlansoprazole Capsules | 30mg, 60mg | Registration |
CHINA dossier | |||
Domperidone Tablets | 10mg | Approved by SFDA | |
CHINA dossier | |||
Esomeprazole Sodium for Injection | 20mg,40mg | Registration | |
CHINA dossier | |||
Mosapride Citrate Tablets | 5mg | Approved by SFDA | |
CHINA dossier | |||
Sodium Rabeprazole | 10mg | Approved by SFDA | |
Enteric-coated Tablets | CHINA dossier | ||
Antidiabetes | Repaglinide Tablets | 0.5mg,1mg | Approved by SFDA |
CHINA dossier | |||
Mitiglinide Calcium Tablets | 5mg,10mg | Approved by SFDA | |
CHINA dossier | |||
Gliclazide Sustained-release Tablets | 30mg | Approved by SFDA | |
CHINA dossier | |||
Bromocriptine Mesilate Tablets | 2.5mg | Registration | |
CHINA dossier | |||
Cardiovascula | Ivabradine HCl tablets | 5mg, 7.5mg | Registration |
CHINA dossier | |||
Dronedarone HCl tablets | 400mg | Registration | |
CHINA dossier | |||
Heparin Sodium Injection | 5ml: 25000IU | Registration in Russia CHINA dossier | |
2ml: 125000IU; 2ml: 5000IU |
Approved by SFDA China dossier | ||
Antithrombitic | Clopidogrel bisulphate tablets | 75mg | Registration |
CHINA dossier | |||
Vitamins | Vitamin A and E soft capsules | Vitamin A: 5000 units Vitamin E: 20 mg. |
Approved by SFDA Russia MOH |
CHINA dossier | |||
Vitamin E soft capsules | 100 mg | Approved by Russia MOH CHINA dossier | |
100 mg 50 mg 5 mg |
Approved by SFDA China dossier | ||
Antiemetic | Palonosetron HCl Injection | 5ml: 0.25mg | Registration |
CHINA dossier | |||
Granisertron HCl Injection | 1ml:1mg/3ml:3mg | Registration | |
CHINA dossier | |||
Ondansetron HCl Injection | 2ml:4mg/4ml: 8mg | Registration | |
CHINA dossier | |||
Tropisetron HCl Injection | 2ml:2mg/5ml:5mg | Registration | |
CHINA dossier | |||
Anti-inflammatory | Celecoxib Capsules | 0.2g | Registration |
CHINA dossier | |||
Ibuprofen Suspension | 100ml:2g | Registration | |
CHINA dossier | |||
Chronic Gout drug | Febuxostat Tablets | 40mg, 80mg | Registration |
CHINA dossier | |||
Contract media | Iodixanol Injection | 100ml:65.2g(100ml:32g I) | Approved by SFDA |
CHINA dossier | |||
Ioversol Injection | 20ml:13.56g; 50ml:33.9g; 100ml: 67.8g |
Approved by SFDA | |
( each1ml contains 320mg iodine) |
CHINA dossier | ||
postmenopausal osteoporosis |
Zoledronic Acid for Injection | 4mg (calculad on anhydrous zoledronic acid) | Approved by SFDA |
CHINA dossier | |||
the others | Tamsulosin HCl | 0.2mg | Approved by SFDA |
Sustained-release Capsules | CHINA dossier |