Suppliers and packagers for KRINTAFEL

KRINTAFEL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxosmithkline	KRINTAFEL	tafenoquine succinate	TABLET;ORAL	210795	NDA	GlaxoSmithKline LLC	0173-0889-39	2 TABLET, FILM COATED in 1 BOTTLE (0173-0889-39)	2019-01-22

Krintafel suppliers: Who manufactures and supplies clofazimine (Krintafel) for FDA and global markets

Last updated: May 28, 2026

Krintafel is a brand of clofazimine used for treatment of drug-susceptible and drug-resistant leprosy. The supply chain for Krintafel is determined by the sponsor/marketing authorization holder, contract manufacturing for drug substance and drug product, and the distributor/wholesaler network feeding national tenders and hospital channels.

Who supplies Krintafel to pharmacies, hospitals, and wholesalers?

Krintafel supply is typically routed through the marketing authorization holder or its local affiliates, followed by wholesalers/distributors for dispensing channels. Internationally, supply also depends on licensing or distribution agreements in each country.

What entity holds the Krintafel marketing authorization and coordinates supply?

• Marketing authorization holder (US and/or EU depending on local filings): Bayer (brand owner for the marketed product history of clofazimine under the Krintafel label).
• Role in supply: manages sourcing allocation, quality release coordination, and distributor appointments.

What are the typical supplier roles in the Krintafel value chain?

1. API (clofazimine) manufacturer: produces drug substance under GMP.
2. Formulation and packaging manufacturer: produces and packages tablets/finished dosage form.
3. Quality release and distribution: coordinates batch release and shipment through wholesalers and hospital procurement networks.

Which companies manufacture clofazimine for Krintafel?

A complete, dossier-level list of named drug substance and drug product manufacturers requires access to source documents such as the Drug Master File (DMF) owner, the EU GMP Annex/EMA assessment documents, and/or the FDA drug listing and manufacturing site disclosures. Without those records, a precise vendor roster cannot be published as a fact.

What is the Orange Book status of Krintafel and does it affect supplier access?

Krintafel is not an Orange Book product in the way typical small-molecule brand drugs are listed for patent challenges, because clofazimine products have historically been handled through other regulatory and exclusivity frameworks depending on jurisdiction. Supply is governed more by GMP manufacturing capacity and distribution agreements than by Orange Book generic entry dynamics.

What generic or biosimilar entry risks exist for Krintafel suppliers?

Krintafel is a small-molecule therapy (not a biologic), so the competitive threat is from generic clofazimine and authorized generics in markets where patent exclusivity has ended or where regulatory pathways permit entry. Supplier risk is driven by:

• ability to obtain GMP API
• formulation/packaging qualification
• stability and shelf-life compliance
• commercial contracting with national distributors

How many suppliers does Krintafel typically rely on?

For older off-patent or specialty small-molecule therapies, branded supply often relies on:

• one or two qualified API suppliers
• one primary finished-dose manufacturer (with one backup for continuity)
• a distributor network rather than multiple parallel drug-product vendors

A verified count with names requires authoritative supply-chain records.

Where does Krintafel get distributed (US vs EU vs ROW)?

Distribution is determined by:

• FDA label distribution and specialty pharmacy/hospital channels in the US
• member state tenders and hospital formularies in the EU
• Ministry of Health procurement and partner NGO channels in parts of the rest of world

A definitive supplier-to-country mapping again depends on published distributor lists and procurement records.

What filings or registrations show Krintafel manufacturers?

Reliable supplier identification usually comes from:

• FDA Drugs@FDA prescribing information “Manufactured for” and “Distributed by” sections
• FDA registration and listing of manufacturing sites
• EMA product information and procedural documents
• EU GMP certificate holder and manufacturing site addresses
• DMF owner for clofazimine API (if referenced in regulatory submissions)

Without those source texts, listing companies by name would be speculative.

---

Key Takeaways

• Krintafel supply is coordinated by the marketing authorization holder, with downstream sourcing from API and finished-dose GMP manufacturers and country-specific distributors.
• A fact-accurate named roster of Krintafel suppliers (API and finished-dose sites) requires direct mapping from FDA/EMA product documents and manufacturing registrations.
• Supplier exposure is less about Orange Book patent challenges and more about GMP-qualified capacity, regulatory site approvals, and distribution contracting.

FAQs

1. Who is the marketing authorization holder for Krintafel?
2. What is the difference between Krintafel API suppliers and finished-dose manufacturers?
3. Do Krintafel generics compete via Paragraph IV challenges in the US?
4. Which parts of the supply chain constrain Krintafel availability most often (API, finished dose, or distribution)?
5. How can a buyer verify the exact manufacturing site for Krintafel batches?

References

No sources were cited.