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Bedaquiline
CAS No.: 843663-66-1
Synonym: Sirturo
Mol. Formula: C₃₂H₃₁BrN₂O₂
Mol. Weight: 555.51 g/mol
ATC Code: J04AK05
Therapeutic Category: Antitubercular
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Bedaquiline API is produced with high purity, precise potency, and strict impurity control to meet global regulatory standards. Each batch undergoes advanced analytical testing, including HPLC, mass spectrometry, and stability profiling, ensuring consistent performance for MDR-TB treatment formulations.

2) Comprehensive Documentation
Amber Lifesciences provides a complete documentation package for Bedaquiline API, including COA, DMF/CTD dossiers, stability data, method validation, MSDS, and regulatory support files. This ensures seamless approvals and compliance across global markets.

3) Secure Supply Chain
A robust and fully traceable supply chain ensures safe and uninterrupted delivery of Bedaquiline API. Controlled storage, validated packaging, and temperature-regulated logistics maintain API integrity throughout global distribution.

4) Manufacturer & Supplier Expertise
Produced in advanced GMP-certified facilities, Bedaquiline API benefits from strong chemical synthesis expertise, optimized scale-up processes, and stringent quality systems. Skilled technical teams ensure consistent batch quality and regulatory alignment for global pharmaceutical partners.

5) Amber Lifesciences’ Role
Amber Lifesciences supports the supply of high-quality Bedaquiline API with GMP manufacturing, complete documentation, and a secure global supply chain. Their expertise helps pharmaceutical companies develop reliable and compliant MDR-TB treatment

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