FDF
NO. | ProductName | Strength | Indication | Status |
01 | Abemaciclib Tablets | 50mg;100mg;150mg | Breast cance | BE study, US GMP, CN GMP |
02 | Apalutamide Tablets | 60mg | Prostate cancer | Prepare for PV, US GMP, EU GMP |
03 | Ibrutinib Capsules | 140mg | Lymphoma | Approved(China), US GMP, CN GMP |
04 | Ibrutinib Tablets | 140mg;420mg | Lymphoma | Submitted(China), CN GMP |
05 | Relugolix Tablets | 120mg | Prostate cancer | Prepare for PV, PIC/S, CN GMP |
06 | Brexpiprazole Tablets | 0.5mg;1mg;2mg | Antidepressant, Antipsychotic, Agitation (Alzheimer's disease) | Approved(China), PIC/S, CN GMP |
07 | Vortioxetine Hydrobromide Tablets | 5mg;10mg | Antidepressant | Approved(China), PIC/S, CN GMP |
08 | Agomelatine Tablets | 25mg | Antidepressant | Approved(China), PIC/S, CN GMP |
09 | Brivaracetam Tablets | 25mg;50mg | Antiepileptic | BE equivalent, CN GMP |
10 | Finerenone Tablets | 10mg | Chronic kidney disease(CKD), Heart failure (HF) | Submitted(China), US GMP, CN GMP |
11 | Minocycline Hydrochloride Capsules | 50mg | Tetracycline antibiotics | Submitted(China), US GMP, CN GMP |
12 | Isavuconazonium Sulfate for Injection | 200mg | Invasive aspergillosis, Invasive mucormycosis | Approved(China), meet EU GMP |
13 | Lacosamide Solution for Injection | 20ml:0.2g | Antiepileptic | Approved(China), meet EU GMP |
14 | Pantoprazole Sodium for Injection | 40mg | Gastrointestinal bleeding, Hyperacidity | Approved(China), meet EU GMP |
15 | Omeprazole Sodium for Injection | 40mg | Gastrointestinal bleeding, Hyperacidity | Approved(China), meet EU GMP |
16 | Levofloxacin Injection | 20ml:0.5g | Bacterial infections | Approved(China), meet EU GMP |
17 | Lipoic AcidIn jection | 12ml:0.3g | Sensory abnormalities due to diabetic peripheral neuropathy | Approved(China), meet EU GMP |
18 | Parecoxib Sodium for Injection | 20mg;40mg | For short-term postoperative analgesia and relief of moderate to severe acute pain | Approved(China), meet EU GMP |
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