| 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 | ||