Bivalirudin Injection

Formulation (FDF) · Injection · 250mg

Back to List

Formulation (FDF)Confidentiality：Public

INN / Generic Name: Bivalirudin Injection
Dosage Form: Injection
Strength: 250mg
Therapy Area: Cardiovascular
Indication: Unstable angina; Percutaneous transluminal coronary angioplasty
Current Status: Official FDF licensing catalog (UB487)
GMP Certification: US - FDA; EU - EMA
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 StatesEU

Process / Sequence / Exact Price

Process Summary: —
Exact Price

Supplier

Unibest Industrial Co., Ltd.

CN · Compliance Desk

KYB status: KYB verified
Business lines: Formulation Licenses
Listed products: 860 items

Contact becomes visible after CDA is signed

Estimated Registration Timeline (European Union (EMA · DCP / MRP))

32-38 months

Pathway：DCP (decentralised procedure) / MRP (mutual recognition procedure)

Estimated Cost：US$ 150k-350k

· BE study or BCS biowaiver justification (not currently provided)
· First-time GMP inspection / certification preparation (no recognised GMP certificate held yet)
· Full Module 3 (3.2.S / 3.2.P)
· ASMF or CEP letter of access

Note: Timelines, costs and recommendations on this page are empirical ranges and preliminary system judgements; the target-country regulator's current requirements and confirmation by the RA / compliance owner prevail.