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Bedaquiline bulk supplier for pharma manufacturers

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.

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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.

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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

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.

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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.

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