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Suppliers and packagers for generic pharmaceutical drug: nifurtimox
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nifurtimox
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bayer Healthcare | LAMPIT | nifurtimox | TABLET;ORAL | 213464 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-750-01 | 1 BOTTLE in 1 CARTON (50419-750-01) / 100 TABLET, FILM COATED in 1 BOTTLE | 2020-10-01 |
| Bayer Healthcare | LAMPIT | nifurtimox | TABLET;ORAL | 213464 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-751-01 | 1 BOTTLE in 1 CARTON (50419-751-01) / 100 TABLET, FILM COATED in 1 BOTTLE | 2020-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: nifurtimox
Nifurtimox suppliers list: who manufactures nifurtimox (US, EU, and global) and how to source API and finished doses
Nifurtimox sourcing is dominated by a small number of manufacturers capable of producing the active pharmaceutical ingredient (API) and, in key markets, supplying finished dosage forms through licensing or local distribution. In practice, procurement splits into (1) API for formulators and (2) finished nifurtimox tablets/capsules supplied to national health systems or importers.
What matters for sourcing: confirmed regulatory manufacturing for the target jurisdiction (FDA-registered sites for US, EMA/competent authority acceptance for EU markets), DMF/EDMF availability for the API, and whether the supplier can support dossier access for controlled distribution.
Core commercial reality: nifurtimox is a niche anti-trypanosomal product with limited supplier breadth versus mainstream generics, so lead times and allocation can be material.
Who supplies nifurtimox API and finished drug products worldwide?
Answer (procurement view): Nifurtimox is supplied by a limited set of pharmaceutical API manufacturers and branded/generic finished-dose suppliers in endemic and public-sector markets. In many countries, the practical supplier is an importer or distributor tied to the approved finished-dose marketing authorization holder rather than a direct API-to-procurement pathway.
API supply channels used in tenders and commercial procurement
- API-only supply to contract manufacturers (for tablet/capsule manufacture).
- Finished-dose supply under marketing authorizations held in-country.
- Distributor/importer model where the distributor sources from an approved manufacturer and files through local regulatory pathways.
Which companies manufacture nifurtimox tablets or capsules?
Answer (commercial procurement view): Finished-dose supply typically tracks marketing authorization holders in each jurisdiction, which often differ from API producers. For buyers, the reliable route is to validate:
- the finished-dose sponsor on the label and in national drug registrations,
- the manufacturing site(s) listed for the finished product and API,
- whether the product is the same strength and dosage form as the intended market.
Typical dosage form supply constraints
- Tablet vs capsule availability varies by country and historical procurement batches.
- Strength and excipient packages can differ even when the API is identical, affecting compatibility for substitution or scale-up.
What regulators list nifurtimox manufacturers and manufacturing sites?
Answer (regulatory view): Buyers typically screen manufacturing sites using:
- US FDA registration and drug listing (where applicable),
- EMA/competent authority public registers for Europe,
- national medicines agency databases for marketed product listings,
- DMF (US) or EDMF (EU) for API dossier sourcing.
US-focused checks
- FDA registration for the manufacturing site producing API and/or finished dose.
- Listing status and label configuration for nifurtimox dosage forms.
EU-focused checks
- EMA-related databases for marketing authorization holders and manufacturing sites (plus national rollouts).
- EDMF availability where the API is sourced through formal dossier pathways.
How to find nifurtimox suppliers via DMF/EDMF and regulatory filings?
Answer (sourcing workflow): The fastest path to a compliant supplier short-list is:
- identify the target jurisdiction’s approved product(s) and marketing authorization holder,
- map to the labeled manufacturing sites for API and finished product,
- request access to DMF/EDMF references where the buyer must cross-reference for registrations or tech transfer,
- verify current GMP status for the manufacturing sites intended for supply.
Buyer deliverables when qualifying a nifurtimox supplier
- GMP inspection evidence for API and finished dose sites,
- confirmation of free-to-supply status (not limited to specific tenders),
- batch release testing capability for nifurtimox assay/impurity specs,
- documentation support for regulatory submissions (CoAs, validation summaries, quality agreements).
Which procurement routes work best for nifurtimox: API purchase vs finished-dose tendering?
Answer (buying strategy):
- API purchase works when a manufacturer already holds formulation capability, has regulatory pathways for local registration, and can file or cross-reference DMFs/EDMFs.
- Finished-dose tendering/importing is usually faster when a buyer needs a ready-to-market product for public health programs or immediate distribution.
When API sourcing is harder
- niche APIs can have constrained DMF access,
- fewer suppliers can meet simultaneous quality, lead time, and documentation requirements.
What patent and exclusivity status affects supplier availability for nifurtimox?
Answer (market-structure view): Nifurtimox is an older drug, and supplier availability is primarily driven by ongoing GMP capacity, market pull from endemic regions, and regulatory/filing status. Patent activity can still affect formulation changes, process improvements, or particular dosage-strength packaging, but supplier access in most settings is determined by manufacturing and regulatory readiness more than by hard exclusivity.
Where do nifurtimox supply shortages or allocation risk come from?
Answer (risk drivers):
- low global demand concentration in endemic/public-sector markets,
- limited number of GMP-capable API producers,
- batch-to-batch variability in impurity profiles requiring strict QC release,
- logistics and packaging constraints for tablets/capsules shipped in tenders.
How does nifurtimox supplier landscape compare with other anti-trypanosomal drugs?
Answer (competitive procurement view): Compared with newer or higher-volume anti-parasitics, nifurtimox has fewer active market suppliers in many regions, so buyers often see more direct alignment between:
- procurement organizations,
- a narrow set of approved manufacturers/importers,
- and long lead times.
Key Takeaways
- Nifurtimox supply is concentrated in a limited number of API and finished-dose manufacturers, with many markets served via importer/distributor pathways.
- Supplier qualification depends on mapping labeled manufacturing sites and dossier support (DMF/EDMF) to the target jurisdiction.
- For procurement, the operational choice is usually finished-dose tendering/importing versus API purchase plus tech transfer and regulatory filing burden.
- Supply risk is driven more by manufacturing capacity and regulatory readiness than by broad global competition.
FAQs
- How do I validate a nifurtimox API supplier for regulatory submissions?
- What documents are typically required to qualify a nifurtimox finished-dose distributor in a national procurement?
- Do nifurtimox tablet and capsule specifications differ materially by supplier?
- How can a buyer identify the API manufacturing site behind a nifurtimox finished product label?
- What lead-time factors most often affect nifurtimox public-sector tenders?
References
No sources provided in the prompt, and no external regulatory or commercial databases were cited.
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