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Bedaquiline bulk supplier for pharma manufacturers

Bedaquiline Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 100 mg

Reference Brands: Sirturo (USA/EU)

Category: Antibiotics

Bedaquiline is available in Tablets and strengths such as 100 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Bedaquiline is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Bedaquiline can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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📘 Sourcing Guide

Product Description:

Bedaquiline, also known as BDQ and marketed under the brand name Sirturo, is an oral antibiotic used for the treatment of active tuberculosis, specifically multidrug-resistant (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB). It is used in combination with other anti-tuberculosis medications to enhance treatment efficacy and reduce the bacterial load in patients with resistant forms of TB.

Approved by the U.S. Food and Drug Administration in December 2012 under a fast-track accelerated approval program, Bedaquiline provides a critical option for cases where conventional therapies are ineffective or not tolerated. As a diarylquinoline-class antibiotic, it works by selectively inhibiting mycobacterial ATP synthase, an enzyme essential for energy production in Mycobacterium tuberculosis, thereby killing the bacteria.

Bedaquiline is available as oral tablets, typically in 100 mg strength, and is administered as part of a carefully monitored treatment regimen due to potential cardiac and hepatic side effects. Its introduction has significantly improved outcomes in patients with drug-resistant tuberculosis, offering a novel mechanism of action that complements standard TB therapies.

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Frequently Asked Questions

Bedaquiline is used for the treatment of multidrug-resistant tuberculosis (MDR-TB) in adults and adolescents when standard therapies are not effective or suitable.

Bedaquiline is a chemically synthesized diarylquinoline antibiotic that targets mycobacterial ATP synthase.

The trade name of Bedaquiline is Sirturo.

Bedaquiline (Sirturo) is developed and marketed by Johnson & Johnson.

The generic name of Sirturo is Bedaquiline fumarate.

The brand name of Bedaquiline is Sirturo.

Bedaquiline is manufactured at Johnson & Johnson-approved facilities under international GMP and regulatory standards.

Yes, Bedaquiline is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Bedaquiline is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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