3-Methyl-piperazin-2-one

Intermediate

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IntermediateConfidentiality：Public

INN / Generic Name: 3-Methyl-piperazin-2-one
CAS No.: 23936-11-0
Current Status: Official intermediate catalog (API: Fezolinetant)
MOQ: On request
Lead Time: On request
Price Range: On request

Formulation & registration fields (API/FDF oriented — tap to expand)

Dosage Form: —
Strength: —
Therapy Area: Pharmaceutical Intermediates
Indication: API: Fezolinetant
GMP Certification: —
CEP: No
DMF Type: —
Stability Data: —
BE Required: Not required / waivable
Registration Pathway: FSO supply (non-registered substance)

HS Code

2933.591100 customs bills on file

Registrable Markets

Global

Process / Sequence / Exact Price

Process Summary: —
Exact Price

Supplier

Unibest Nantong cGMP Site

CN · Wei Zhang

KYB status: KYB verified
Business lines: Pharmaceutical IntermediatesFormulation Licenses
Listed products: 335 items
Intermediates: 332 items
CEP-held products: 1 items

Contact becomes visible after CDA is signed

Registration timeline estimate (API/FDF oriented)

Estimated Registration Timeline (Other Southeast Asian countries (not listed))

26-38 months

Pathway：NP (national procedure) / partially harmonised ASEAN route

Estimated Cost：US$ 30k-100k

· BE study or BCS biowaiver justification (not currently provided)
· First-time GMP inspection / certification preparation (no recognised GMP certificate held yet)
· CPP / COPP
· GMP certificate

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.