Bedaquiline 100 mg Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 100 mg
Reference Brands: Sirturo (USA/EU)
Category: Antibiotics
Bedaquiline is a Antibiotics product available as Tablets in strengths 100 mg. It corresponds to the reference brand Sirturo (USA/EU). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.
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.
Bedaquiline — third party manufacturing & bulk supply
Bedaquiline 100 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Bedaquiline listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Bedaquiline →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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.
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