Order Online Levonorgestrel API from Amber Lifesciences Pvt. Ltd. — a second-generation synthetic progestogen widely used as a key Active Pharmaceutical Ingredient (API) in the formulation of oral contraceptives and emergency contraception. Its proven pharmacological profile, stability, and broad global regulatory acceptance make it an essential choice for pharmaceutical manufacturers developing reproductive healthcare formulations.
Amber Lifesciences Pvt. Ltd. supplies GMP- and ISO-compliant Levonorgestrel API, ensuring product consistency, international compliance, and premium quality for bulk buyers and formulation companies worldwide.
Key Chemical & Physical Properties of Levonorgestrel API
- Chemical Name: 13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one
- CAS Number: 797-63-7
- Molecular Formula: C₂₁H₂₈O₂
- Molecular Weight: 312.4 g/mol
- Appearance: White to almost white crystalline powder
- Solubility: Almost insoluble in water; readily soluble in acetone, ethanol, and dichloromethane.
- Melting Point: 240–245°C
Global Applications and Market Utilization of Levonorgestrel API Formulations
Levonorgestrel API is a trusted choice for pharmaceutical manufacturers developing:
- Oral contraceptive tablets, either as single-ingredient or in combination formulations
- Hormonal intrauterine systems (IUS/IUD)
- Long-acting hormonal implants and injectable solutions
Widely recognized for its role in reproductive health, Levonorgestrel bulk API supports family planning medications across LATAM, Europe, Southeast Asia, MENA, and Africa. Many national essential medicine programs and public health initiatives include Levonorgestrel-based formulations, reflecting its continued demand in global markets.
Manufacturing Compliance & Quality Standards at Amber Lifesciences
- Purity: ≥98% (HPLC tested)
- Conforms to: USP, EP, BP, and IP standards
- Synthesis: Derived from norethisterone or steroidal intermediates
- Documentation Available:
- CoA (Certificate of Analysis)
- MSDS (Material Safety Data Sheet)
- DMF (Available on request)
- Stability data and impurity profile
Storage, Stability & Regulatory Guidance
- Storage: Store in airtight containers at 20–25°C; protect from light and air
- Stability: Sensitive to oxidation; antioxidant additives like BHT may be required in formulations
- Regulatory: Listed in the WHO Essential Medicines List; manufactured in GMP-compliant facilities and acceptable for global regulatory filings
Why Choose Amber Lifesciences Pvt. Ltd. for Levonorgestrel API?
Amber Lifesciences is a reliable Indian API manufacturer and global supplier, offering:
- GMP- and ISO-compliant production facilities
- Strict adherence to ICH Q7 quality systems and global audit readiness
- Custom packaging options for bulk and formulation-grade Levonorgestrel
- Full regulatory support, including CoA, MSDS, DMF, and Technical Dossier
- Trusted delivery to Brazil, France, Germany, Japan, LATAM, Africa, and Southeast Asia
Amber Lifesciences ensures international standards, responsive documentation, and flexible supply chain solutions to meet diverse customer needs.
Conclusion
Levonorgestrel API is a cornerstone ingredient in modern contraceptive and reproductive health formulations. Its efficacy, regulatory alignment, and broad application make it a strategic API for manufacturers worldwide.
For consistent quality, compliant manufacturing, and dependable global delivery—Amber Lifesciences Pvt. Ltd. is your trusted Levonorgestrel API partner.