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产品系列
|
Indication |
Product |
Dosage Form |
Strength& Package form |
Intended Market |
Status |
|
Anti-epilepsy |
Carbamazepine |
Sustained Release Tablets |
100mg,200mg&400mg 100CT/Bottle |
US/ China |
FDA: Approved NMPA: Approved |
|
|
Oxcarbazepine |
Tablets |
150mg,300mg Blister |
China |
NMPA: Under review 300 mg Es. Approved in Q2 2024 |
|
|
Oxcarbazepine |
Oral suspension |
100ml:6g |
China |
Pilot BE completed Process validation undergoing |
|
|
Lacosamide |
Tablets |
50mg,100mg Blister |
China |
NMPA: Under Review |
|
Antidiabetic |
Sitagliptin + Metformin |
Sustained Release Tablets |
Us market: 100/1000,50/1000 China: 100/1000,50/1000,50/500 |
US China |
FDA: Under review NMPA: Under review Es. Approved in Q4 2024 |
|
|
Sitagliptin Phosphate |
Tablets |
50mg,100mg Blister |
China |
NMPA: Approved |
|
|
Sitagliptin + Metformin |
Tablets |
50mg/850mg Blister |
China |
NMPA: Approved |
|
|
Gliclazide |
Sustained Release Tablets |
60mg Blister |
China |
NMPA: Approved |
|
|
Dapagliflozin + Metformin |
Sustained Release Tablets |
5mg/500mg 5mg/1000mg 10mg/500mg 10mg/1000mg Blister |
China |
Technical transfer Pilot BE undergoing |
|
Antidepressant |
Venlafaxine Hydrochloride |
Sustained Release Capsules |
75mg Blister |
China |
NMPA: Under review |
|
|
Vortioxetine Hydrobromide |
Tablets |
5mg,10mg Blister |
China |
Pilot BE study completed |
|
Anticoagulant |
Edoxaban Tosylate |
Tablets |
30mg,60mg Blister |
China |
Pilot BE study completed |
|
ED |
Sildenafil Citrate |
Orally Disintegrating Tablets |
50mg Blister |
China |
NMPA: Under Review |
|
PD |
Rasagiline Mesylate |
Tablets |
1mg Blister |
China |
Pilot BE completed |
|
Potassium-competitive acid blocker |
Vonoprazan Fumarate |
Tablets |
10mg,20mg Blister |
China |
PV completed Stability study undergoing |
|
Antianxiety |
Tandospirone Citrate |
Tablets |
5mg,10mg Blister |
China |
PV completed Stability study undergoing |
|
Schizophrenia |
Brexpiprazole |
Tablets |
0.5mg,1mg,2mg Blister |
China |
Technical transfer |
|
Anti-influenza |
Baloxavir Marboxil |
Tablets |
20mg, 40mg Blister |
China |
Technical Transfer Pilot BE completed |
|
NSAIDs |
Diclofenac Diethylamine |
Gel Topical |
1%: 20g/tube,50g/tube 25: 50g/tube |
China EMA |
Technical Transfer |
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