Doravirine
Formulation (FDF) · Film-coated tablets · 100 mg
Formulation (FDF)US DMF IIConfidentiality:Visible after CDA
- INN / Generic Name
- Doravirine
- Dosage Form
- Film-coated tablets
- Strength
- 100 mg
- Therapy Area
- Antivirals
- Indication
- HIV-1 infection (NNRTI)
- Current Status
- Marketed (China + selected emerging markets)
- GMP Certification
- WHO PQ / China GMP
- CEP
- No
- DMF Type
- US DMF II
- Stability Data
- 36 months
- BE Required
- Yes
- Registration Pathway
- NP / DCP (per market)
- MOQ
- 500,000 tablets
- Lead Time
- 60 days
- Price Range
- US$ 0.35-0.70 / tablet
HS Code
3004.903 customs bills on file
Registrable Markets
BrazilMoroccoVietnam
Process / Sequence / Exact Price
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