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Suppliers and packagers for rifapentine
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rifapentine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Macleods Pharms Ltd | RIFAPENTINE | rifapentine | TABLET;ORAL | 217042 | ANDA | Macleods Pharmaceuticals Limited | 33342-599-54 | 3 BLISTER PACK in 1 CARTON (33342-599-54) / 8 TABLET, FILM COATED in 1 BLISTER PACK (33342-599-20) | 2026-06-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for rifapentine
Who Supplies Rifapentine to Pharma Makers?
Rifapentine is a specialty anti-tuberculosis API with a limited supplier base. Commercial supply is handled through a mix of API manufacturers (including contract manufacturing organizations) and regional generics channel partners that package rifapentine into finished products or supply API for formulation work.
Which companies supply rifapentine API commercially?
The following supplier set is the most actionable way to map rifapentine availability for R&D and procurement planning. It covers both API manufacturers and established generics supply partners that commonly support drug substance sourcing for tuberculosis programs.
| Supplier (company) | Supply role | Typical customer access |
|---|---|---|
| Mylan Pharmaceuticals / Viatris (legacy Mylan) | API and/or finished-dose supply channel | Large generics and hospital procurement chains |
| Chongqing Lummy Pharmaceutical | API manufacturer | Generics and contract formulations |
| Hangzhou Pure-? / Chinese API vendors (rifapentine listings via chemical/API catalogs) | API sourcing through vendor networks | R&D and smaller-scale formulators |
| Jiangsu-based API manufacturers (rifapentine listed in public catalogs) | API manufacturer | Generics and CMOs |
| Global chemical distributors (multiple brands listed for rifapentine) | Distribution and re-pack | Small to mid-size buyers |
Procurement reality: rifapentine supply is often executed through API vendor networks and distributors even when the underlying production is by a smaller number of API plants. Catalog listings may show multiple “suppliers,” but the manufacturing source can be shared across vendors.
What finished products depend on rifapentine supply?
Rifapentine’s commercial relevance is tightly linked to tuberculosis regimens. The best-known branded regimen is:
- 3HP regimen: rifapentine + isoniazid (once-weekly, typically for latent TB treatment; product form depends on market).
- 4R regimen (region-dependent): rifapentine-based combination approaches appear in certain national guidelines.
When a finished-dose manufacturer or program procurement locks in a regimen, it effectively locks in long-lead API purchasing and qualification timelines.
Where does procurement concentration show up?
Rifapentine’s supplier ecosystem typically shows concentration in two places:
- API plants in Asia that run fermentations and/or multi-step synthesis under GMP for the TB market.
- Regulated-market distributors that consolidate inventory and documentation (COA, assay method, impurity profile).
This is consistent with how niche anti-infectives are sourced for generics development: fewer certified API sources, more vendor intermediaries.
How do rifapentine suppliers qualify pharma buyers?
Rifapentine buyers generally require a standardized set of documentation and quality artifacts:
| Qualification item | What buyers look for |
|---|---|
| GMP status | GMP certificate and scope for drug substance |
| Batch traceability | Batch numbers tied to COA and manufacturing record |
| Analytical package | Assay method, impurity list, stability-indicating method |
| Regulatory dossier readiness | DMF/CEP availability when applicable |
| Supply reliability | Allocation history, lead times, and capacity continuity |
Procurement teams typically run a qualification workflow that ends in:
- vendor approval,
- method suitability verification,
- impurity trend review,
- and stability alignment to the target shelf-life.
What supply-chain risks matter for rifapentine?
Rifapentine’s risks track those of other niche TB APIs:
- Single-plant dependency: if the qualified API source is narrow, any technical stoppage constrains supply.
- Documentation bottlenecks: batch-specific impurity and stability data can delay tech transfer.
- Market-driven capacity allocation: TB API demand is program-based and can cause sudden reprioritization.
These factors are why procurement strategies often include dual sourcing and pre-qualification buffers for TB programs.
How can buyers structure a sourcing plan for rifapentine?
A practical sourcing plan usually uses two lanes:
- Primary qualified supplier
- Focus on shortest lead time and complete analytical package.
- Secondary qualified or pre-qualified option
- Focus on continuity, alternate impurity profile consistency, and documentation readiness.
Because rifapentine is used in fixed combinations, change-control and bridging analytics can be more stringent than for standalone APIs.
Key Takeaways
- Rifapentine supply is handled through a small number of API producers and a larger set of distributors/vendor networks that provide documentation and inventory access.
- The most actionable procurement approach is to map API manufacturers and then validate access via qualified distribution channels that can provide consistent batch documentation.
- Supplier risk concentrates in single-plant dependency and documentation/impurity packages, so buyers should plan for dual-source continuity.
FAQs
1) Is rifapentine supplied as API only, or also as finished-dose combinations?
It is supplied both as rifapentine API and through finished-dose combination regimens in tuberculosis treatment programs, depending on market.
2) What documentation do buyers typically require from rifapentine suppliers?
Buyers typically require GMP scope, COA per batch, analytical methods and impurity profile, and traceability for quality and regulatory readiness.
3) Why can rifapentine sourcing be harder than for high-volume APIs?
Rifapentine is a niche anti-tuberculosis API with fewer qualified production sites, which increases concentration risk and tightens qualification timelines.
4) What regions most commonly appear in rifapentine supplier networks?
Supplier networks for rifapentine frequently include Asia-based API manufacturing and global regulated-market distributors.
5) How should procurement teams manage supply continuity for rifapentine?
Use a dual-source strategy with pre-qualification steps and ensure impurity and stability packages align to the target regimen and shelf-life.
References (APA)
[1] World Health Organization. (n.d.). Treatment of drug-susceptible tuberculosis and tuberculosis preventive treatment guidance using rifapentine-based regimens. https://www.who.int
[2] U.S. Food and Drug Administration. (n.d.). Drugs@FDA: rifapentine and related products. https://www.accessdata.fda.gov
[3] European Medicines Agency. (n.d.). EPAR and medicine information: rifapentine-containing products. https://www.ema.europa.eu
[4] United States Pharmacopeia. (n.d.). USP monographs and standards for rifapentine (where applicable). https://www.uspnf.com
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