Unibest

Paroxetine Hydrochloride Enteric-coated Sustained-release Tablets

Formulation (FDF) · Sustained-release Tablets · 12.5mg; 25mg

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Formulation (FDF)Confidentiality:Public
INN / Generic Name
Paroxetine Hydrochloride Enteric-coated Sustained-release Tablets
Dosage Form
Sustained-release Tablets
Strength
12.5mg; 25mg
Therapy Area
Others > Psychiatry
Indication
Major depressive disorder; panic disorder; social anxiety disorder; premenstrual dysphoric disorder
Current Status
Official FDF licensing catalog (UB205)
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
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Exact Price