Unibest

Rosuvastatin Calcium Tablet

Formulation (FDF) · Tablet · 5mg,10mg, 20mg, 40mg

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Formulation (FDF)Confidentiality:Public
INN / Generic Name
Rosuvastatin Calcium Tablet
Dosage Form
Tablet
Strength
5mg,10mg, 20mg, 40mg
Therapy Area
Metabolic & Endocrinology
Indication
Primary hypercholesterolaemia; Mixed dyslipidaemia; Homozygous familial hypercholesterolaemia
Current Status
Official FDF licensing catalog (UB825)
GMP Certification
US - FDA; CN - NMPA; EU - EMA; PH - FDA​​
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
ChinaUnited StatesEUPhilippines

Process / Sequence / Exact Price

Process Summary
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Exact Price