Norethisterone Enanthate
CAS No.: 3836-23-5
Synonym: Nur-Isterate, Noristerat
Mol. Formula: C₂₇H₃₈O₃
Mol. Weight: 410.59 g/mol
ATC Code: G03AC06
Therapeutic Category: Progestational hormone
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Amber Lifesciences ensures that Norethisterone Enanthate meets stringent international quality standards. Each batch undergoes advanced analytical testing for purity, impurity profiling, assay, particle characteristics, and stability. Controlled manufacturing environments and validated processes guarantee consistency, high potency, and full pharmacopeial compliance.

2) Comprehensive Documentation
Amber provides complete regulatory and technical documentation to support global submissions. This includes DMFs, Certificates of Analysis, stability studies, process validation data, QMS certifications, and other essential dossiers. Such comprehensive documentation ensures smooth regulatory interactions and accelerates product approvals.

3) Secure Supply Chain
Ensuring continuous availability of hormonal APIs is a key focus. Amber Lifesciences maintains a robust, risk-mitigated supply chain with qualified manufacturing partners, reliable sourcing of raw materials, and stringent logistics monitoring. This reduces disruption risks and ensures timely deliveries worldwide.

4) Manufacturer & Supplier Expertise
With strong technical knowledge and years of experience, Amber assists manufacturers in formulation development, quality alignment, and regulatory strategy. Their expertise enables optimized processes and improved market readiness.

5) Amber Lifesciences’ Role
Amber Lifesciences acts as a trusted global facilitator, connecting high-quality API production with pharmaceutical companies. Their commitment to excellence, compliance, and long-term partnership makes them a reliable supplier of Norethisterone Enanthate API across diverse markets.

Active Pharmaceutical Ingredient (API) – Not for Direct Human or Veterinary Use.