Suppliers and packagers for SIRTURO

SIRTURO

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384	NDA	Janssen Products, LP	59676-701-01	188 TABLET in 1 BOTTLE (59676-701-01)	2012-12-28
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384	NDA	Janssen Products, LP	59676-702-60	60 TABLET in 1 BOTTLE (59676-702-60)	2020-05-27

Suppliers and packagers for SIRTURO

Last updated: May 27, 2026

Sirturo (bedaquiline) Suppliers: Who Manufactures, How Supply Is Structured, and What Risks Matter for Access

Sirturo is the brand name of bedaquiline, an oral antimycobacterial used for multidrug-resistant tuberculosis (MDR-TB) in combination regimens. The supplier picture is dominated by Janssen/Johnson & Johnson as the originator and global brand owner, with contract manufacturing and API sourcing executed through a mix of internal and third-party capabilities under Janssen controls.

Who supplies Sirturo (bedaquiline) in the US market?

Answer: Janssen (Johnson & Johnson) is the primary marketing authorization holder/labeler for Sirturo in major markets, with drug product manufactured by Janssen-controlled manufacturing networks and API sourced through qualified supply chains.

US labeler and distribution

Sirturo’s commercial supply is distributed through the US supply chain under the Janssen label structure (labeler/distributor model typical for specialty anti-infectives). The practical supplier set for access decisions is therefore:

• Brand owner/MAH: Janssen/Johnson & Johnson
• Drug product manufacturers: Janssen-authorized contract manufacturers and/or Janssen sites (release-controlled)
• API suppliers: qualified bedaquiline API manufacturers (GMP-compliant, approved in CMC filings)

What “supplier” means in a regulatory sense

For procurement and access planning, the “supplier” set usually maps to:

• Finished dosage form supplier (tablets under Janssen release)
• API supplier (bedaquiline substance)
• Secondary packing/labeling (if outsourced, still part of the released drug product chain)

What companies manufacture Sirturo tablets (drug product)?

Answer: Sirturo tablet supply is produced through Janssen-controlled manufacturing that includes Janssen sites and/or contract manufacturing organizations (CMOs), with product released under Janssen quality oversight.

How to treat drug product suppliers operationally

For sourcing decisions, treat “tablet suppliers” as:

• Batch release sites named in regulatory documentation and distribution dossiers
• CMO sites that hold the capability to produce tablets meeting Janssen specifications
• Cold chain is not a factor for standard Sirturo tablet logistics, so supply chain risk is primarily GMP capacity, regulatory qualification, and batch release continuity

Who supplies bedaquiline API (active pharmaceutical ingredient)?

Answer: Bedaquiline API is supplied by qualified API manufacturers that have demonstrated GMP compliance and are incorporated into Janssen’s approved supply chain.

API supply structure

In practice, API supply is:

• Qualified through CMC filings (process, controls, and suppliers)
• Subject to change control and comparability for alternate sites
• Released via specification testing as part of drug product batch release

What is the Orange Book status of Sirturo and does it affect who can supply it?

Sirturo is an FDA-approved brand drug. Patent/market exclusivity can shape generic entry timelines and therefore who supplies bedaquiline tablets as an alternative product, but it does not change the core reality that, during the brand exclusivity period, commercial supply is dominated by the brand holder and its contract network.

Why this matters for suppliers

• Generic bedaquiline tablets can only be manufactured by approved entrants if exclusivity/patents permit
• If no generic is approved, “supplier” remains effectively Janssen-backed supply for finished product

Where do sirturo supply risks typically arise (API vs tablet manufacturing)?

Answer: The main constraint points are API continuity and drug product batch release capacity.

API risk points

• Loss of a qualified bedaquiline API site
• Process deviations requiring batch rework or extended testing
• Delays from API lead times (specialty raw materials and synthesis complexity)

Drug product risk points

• Limited CMO/tablet press line capacity
• Sterility is not relevant, but solid oral formulation still has tight control needs for uniformity and dissolution
• Batch release failures can pause shipments even if API exists

How do Janssen’s distribution controls translate into supplier lists?

Answer: Janssen restricts supply to qualified channels, so operational supplier lists for customers typically collapse to:

• Janssen-supplied finished product (through authorized distributors)
• Qualified alternate supply only if and when an approved generic or authorized distributor is in place

Implication for procurement

If an organization needs contingency sourcing, the contingency plan usually focuses on:

• Multiple distribution channels for the same Janssen tablet product
• Alternate procurement routes tied to authorized wholesalers/distributors
• Monitoring for any approved alternative products if exclusivity ends

Which generic or alternative bedaquiline suppliers are possible?

Answer: Generic supply depends on FDA approval status and any patent/exclusivity barriers. If no approved generic is on the market, Janssen remains the supplier of record for bedaquiline tablets.

Paragraph IV and litigation impact on supply

If there are patent challenges (common in anti-TB specialty drugs), they can delay or accelerate generic launches, which changes the supplier set from “brand only” to “brand plus entrants” depending on outcomes and settlements.

Sirturo vs other bedaquiline brands: does the supplier differ?

Answer: If an alternative brand exists in a market, it typically still relies on the same core API origin and qualified drug product manufacturing routes, unless a true generic/alternate NDA supplier is approved.

What changes between brands

• Labeler/distributor name in that geography
• Potentially different tablet manufacturing site if the alternate product is approved independently
• Same API source pattern is common when regulators require tight controls

Key Takeaways

• Sirturo supply is dominated by Janssen/Johnson & Johnson’s approved manufacturing network, including Janssen and/or qualified CMOs for tablets and qualified suppliers for bedaquiline API.
• In supplier mapping, distinguish finished product suppliers (tablet release) from API suppliers (substance) because risks and continuity constraints differ.
• The practical supplier set for buyers remains Janssen-backed until an FDA-approved generic or authorized alternative enters, at which point supplier lists expand based on approvals and patent/exclusivity timelines.

FAQs

1. Who is the labeler/manufacturer of record for Sirturo tablets in the US?
2. Are there multiple bedaquiline API suppliers qualified for Janssen’s Sirturo supply chain?
3. Does CMO capacity affect Sirturo availability more than API supply?
4. If generic bedaquiline tablets enter, how will suppliers and distributors change?
5. What role do FDA approvals and CMC changes play in adding a new bedaquiline supplier?

References (APA)

1. FDA. (n.d.). Drug Approval Packages and FDA labels (Sirturo/bedaquiline). U.S. Food and Drug Administration.