Unibest

Doravirine

Formulation (FDF) · Film-coated tablets · 100 mg

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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

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