Macitentan Tablets
Formulation (FDF) · Tablets · 10mg
Formulation (FDF)Confidentiality：Public
- INN / Generic Name
- Macitentan Tablets
- Dosage Form
- Tablets
- Strength
- 10mg
- Therapy Area
- Respiratory
- Indication
- Pulmonary arterial hypertension
- Current Status
- Official FDF licensing catalog (UB211)
- GMP Certification
- US - FDA; CN - NMPA
- CEP
- No
- DMF Type
- —
- Stability Data
- —
- BE Required
- Not required / waivable
- Registration Pathway
- Registered (market rights transferable / DCP·NP per market)
- MOQ
- On request
- Lead Time
- On request
- Price Range
- On request
HS Code
3004.903 customs bills on file
Registrable Markets
United States
Process / Sequence / Exact Price
- Process Summary
- —
- Exact Price