Send Inquiry
Salmeterol Xinafoate
CAS No.: 94749-08-03
Synonym: Serevent
Mol. Formula: C₆₅H₉₀N₂O₁₀
Mol. Weight: 1055.41 g/mol
ATC Code: R03AC12
Therapeutic Category: Long-Acting Beta-2 Agonist (LABA)
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Salmeterol Xinafoate API is manufactured with a focus on high purity, stability, and consistent potency to meet global pharmaceutical standards. Each batch undergoes rigorous testing for assay, related substances, residual solvents, moisture content, and particle size distribution. Advanced synthesis and purification techniques ensure chemical integrity and suitability for inhalation formulations. Compliance with WHO-GMP, ICH, and major pharmacopeial guidelines guarantees reliable performance in long-acting bronchodilator therapies for asthma and COPD

2) Comprehensive Documentation
A complete regulatory documentation package is provided to support global submissions. This includes DMF/CTD dossiers, stability studies, method validation, process validation, impurity profiling, MSDS, and technical data sheets. All documents follow international regulatory standards, facilitating smooth approvals and efficient product registration in regulated, semi-regulated, and emerging markets.

3) Secure Supply Chain
A robust supply chain ensures the uninterrupted availability of Salmeterol Xinafoate API. Controlled storage conditions, validated packaging, and temperature-monitored logistics maintain product integrity during transit. Full batch traceability, supplier qualification, and reliable distribution networks guarantee timely and consistent delivery to pharmaceutical manufacturers worldwide.

4) Manufacturer & Supplier Expertise
Experienced manufacturers employ advanced synthetic routes, high-quality raw materials, and automated equipment to achieve reproducible batch quality. Analytical and technical support teams assist with formulation challenges, compatibility studies, regulatory compliance, and troubleshooting. Strong quality assurance systems ensure adherence to international manufacturing standards.

5) Amber Lifesciences’ Role
Amber Lifesciences provides high-quality Salmeterol Xinafoate API in Italy through GMP-certified production, transparent documentation, and dependable global logistics. Leveraging expertise in contract manufacturing and regulatory support, Amber Lifesciences ensures consistent quality, reliable supply, and customer-focused service, helping pharmaceutical companies develop effective long-acting bronchodilator therapies for asthma and COPD.

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