Levonorgestrel
CAS No.: 797-63-7
Synonym: Plan B, NorLevo
Mol. Formula: C₂₁H₂₈O₂
Mol. Weight: 312.45 g/mol
ATC Code: G03AC03
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:
Levonorgestrel API, a widely used synthetic progestogen in contraceptives and hormone therapy, is manufactured under stringent GMP and ISO 9001:2015 standards. Each batch undergoes rigorous analytical testing for purity, potency, and impurity profiling to ensure compliance with global pharmacopeial requirements, delivering consistent quality and therapeutic efficacy.

2) Comprehensive Documentation:
Amber Lifesciences provides complete regulatory documentation for Levonorgestrel API, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), stability reports, and CTD/ACTD dossiers. This comprehensive documentation ensures global regulatory compliance and facilitates smooth product registration across regulated and semi-regulated markets.

3) Secure Supply Chain:
A robust and traceable supply chain guarantees uninterrupted availability of Levonorgestrel API. Amber Lifesciences maintains temperature-controlled storage, validated packaging, and continuous quality monitoring, 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 Levonorgestrel API. Their dedicated R&D and quality assurance teams uphold strict international regulatory standards and deliver consistently high-quality APIs.

5) Amber Lifesciences’ Role:
Amber Lifesciences Pvt. Ltd. is a trusted global manufacturer and supplier of Levonorgestrel API. Their commitment to superior quality, comprehensive documentation, and secure supply chain solutions makes them a preferred partner for pharmaceutical companies worldwide seeking GMP-certified, high-quality progestogen APIs.

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