Bedaquiline Fumarate (CAS 845533-86-0)?
Google Keywords: Bedaquiline Fumarate CAS 845533-86-0, MDR-TB Treatment API, ATP Synthase Inhibitor, WHO-Prequalified Tuberculosis Drug, GMP Antimycobacterial Synthesis

?? ?Product Overview?

?Bedaquiline Fumarate? (CAS 845533-86-0) is a ?first-in-class diarylquinoline antimycobacterial agent? approved for the treatment of ?multidrug-resistant tuberculosis (MDR-TB)?. It selectively inhibits mycobacterial ATP synthase, disrupting energy production in Mycobacterium tuberculosis while sparing human mitochondria. This API is pivotal in shortening MDR-TB treatment regimens and improving patient outcomes.

• ?Primary Function?: Targets drug-resistant TB strains with a novel mechanism of action, reducing treatment duration from 18–24 months to 6–9 months.

• ?Applications?: MDR-TB therapy, combination regimens for extensively drug-resistant TB (XDR-TB), and WHO-recommended TB control programs.

? ?Key Advantages?

?? ?High Efficacy? | 90% culture conversion rate in Phase III trials | Superior to traditional TB therapies for resistant strains.
?? ?Selective Action? | 10,000x higher affinity for bacterial ATP synthase vs. human cells | Minimizes systemic toxicity.
?? ?WHO-Prequalified? | Listed in WHO Essential Medicines for MDR-TB | Accelerates global regulatory approvals.
?? ?Stability? | Shelf life of 36 months under controlled storage (2–8°C, protected from light).

?? ?Applications?

1. ?MDR/XDR-TB Treatment?: Core component of WHO-endorsed 6-month oral regimens (e.g., with pretomanid and linezolid).

2. ?Hospital Formulations?: Used in injectable and oral dosage forms for severe TB cases.

3. ?Public Health Programs?: Distributed in high-TB burden countries (e.g., India, South Africa) via Global Fund partnerships.

4. ?Research?: Investigated for nontuberculous mycobacteria (NTM) infections.

?? ?Quality Assurance?

• ?Testing Methods?: HPLC (purity ≥98.5%), GC (residual solvents), XRD (polymorph characterization), and microbial limits per USP <61>.

• ?Standards?: Complies with ICH Q3A/B, USP <823>, and EMA guidelines for antitubercular APIs.

?? ?Market Trends?

The ?global MDR-TB therapeutics market? is projected to grow at ?8.7% CAGR through 2030?, driven by rising MDR-TB cases (≈500,000 annually) and expanded access initiatives. Bedaquiline’s inclusion in WHO guidelines and patent expirations post-2023 are expected to boost generic API demand, particularly in Asia and Africa.

Transform MDR-TB care with Bedaquiline Fumarate – engineered for potency, safety, and alignment with global health priorities.