Entecavir
Formulation (FDF) · Tablets · 0.5 mg / 1 mg
Formulation (FDF)CEPUS DMF II / ASMFConfidentiality：Public
- INN / Generic Name
- Entecavir
- Dosage Form
- Tablets
- Strength
- 0.5 mg / 1 mg
- Therapy Area
- Antivirals
- Indication
- Chronic hepatitis B
- Current Status
- Marketed (China + Southeast Asia + multiple Latin American markets)
- GMP Certification
- EU GMP / WHO PQ
- CEP
- Yes
- DMF Type
- US DMF II / ASMF
- Stability Data
- 48 months
- BE Required
- Yes
- Registration Pathway
- DCP / NP (CEP-supported)
- MOQ
- 1,000,000 tablets
- Lead Time
- 45 days
- Price Range
- US$ 22-45 / 1k tablets
HS Code
3004.903 customs bills on file
Registrable Markets
VietnamBrazilPeruMoroccoSaudi Arabia
Process / Sequence / Exact Price
- Process Summary
- Direct compression / wet granulation (public process summary)
- Exact Price
- US$ 31.0 / 1k tablets