Estradiol
CAS No.: 50-28-2
Synonym: Alora, Climara, Delestrogen
Mol. Formula: C₁₈H₂₄O₂
Mol. Weight: 272.38 g/mol
ATC Code: G03CA03, L02AA01
Therapeutic Category: Hormonal, Steroidal
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality:
Estradiol API, a key estrogen hormone used in hormone replacement therapy and other endocrine treatments, is manufactured under strict GMP and ISO 9001:2015 standards. Each batch undergoes rigorous analytical testing for purity, potency, and impurity profiling, ensuring compliance with global pharmacopeial standards and delivering consistent therapeutic efficacy.

2) Comprehensive Documentation:
Amber Lifesciences provides complete regulatory documentation, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), stability studies, and CTD/ACTD dossiers. This comprehensive documentation ensures regulatory compliance, supports product registration, and facilitates seamless approval in global markets.
3) Secure Supply Chain:

A robust and transparent supply chain ensures uninterrupted availability of Estradiol API. Amber Lifesciences maintains temperature-controlled storage, validated packaging, and real-time tracking, safeguarding product integrity from production to worldwide distribution.

4) Manufacturer & Supplier Expertise:
With deep expertise in steroid chemistry, process optimization, and analytical validation, Amber Lifesciences ensures reproducible, large-scale production of Estradiol API. Their R&D and quality assurance teams maintain high standards of consistency and global regulatory compliance.

5) Amber Lifesciences’ Role:
Amber Lifesciences Pvt. Ltd. is a trusted global manufacturer and supplier of Estradiol API. Their focus on quality excellence, comprehensive documentation, and secure supply chain solutions positions them as a preferred partner for pharmaceutical companies worldwide seeking GMP-certified, high-quality steroid APIs.

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