Suppliers and packagers for generic pharmaceutical drug: Miltefosine

Miltefosine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Knight Theraps	IMPAVIDO	miltefosine	CAPSULE;ORAL	204684	NDA	Profounda, Inc.	69051-300-01	2 BLISTER PACK in 1 CARTON (69051-300-01) / 14 CAPSULE in 1 BLISTER PACK	2015-10-29

MILTEFOSINE Suppliers: Who Provides Bulk Drug, Key Intermediates, and Finished-Dose Inputs

Last updated: June 16, 2026

Miltefosine supply is dominated by a small set of global bulk-drug manufacturers and specialty ingredient suppliers that support clinical and commercial demand for the anti-leishmanial. The procurement map below focuses on entities that manufacture or supply miltefosine API (or controlled-grade miltefosine active) and those that supply closely related intermediates used in API production.

Which companies supply miltefosine API (bulk drug) for pharmaceutical use?

Featured-snippet answer: Miltefosine API is supplied by a limited group of manufacturers; procurement typically routes through API distributors for commercial volumes and through qualification partners for clinical supply.

Bulk API supply chain pattern for miltefosine

• API is typically sourced as miltefosine (active ingredient) in controlled specifications for drug substance use.
• Many buyers do not contract directly with every API plant. They qualify an API manufacturer through a distributor, CMOs, or specialty importers for regulatory documentation.

Common supplier archetypes

• API manufacturers with DMF access (or other regulatory filing linkage)
• Pharmaceutical ingredient distributors that hold safety stock and provide CoA/CoC
• Specialty chemical producers of miltefosine intermediates that supply to API plants

What suppliers provide miltefosine to the market via distributors vs direct manufacturing?

Featured-snippet answer: For most buyers, miltefosine is procured either (1) directly from the API manufacturer under QMS and change-control terms or (2) from an authorized distributor with established regulatory dossiers.

Distributor procurement advantages

• faster lead times on qualified packaging and graded inventory
• documentation bundling (CoA, impurity profile, stability package)
• batch traceability support for pharmacovigilance and audits

Direct manufacturing procurement advantages

• tighter control of impurity profile and polymorph/grade handling
• more direct change-control on synthesis routes and in-process controls
• alignment with CMC timelines for clinical and NDA/MAA lifecycle work

What intermediates and custom-chemistry suppliers support miltefosine API production?

Featured-snippet answer: Miltefosine API production relies on custom intermediate chemistry, which is often supplied by specialty chemical manufacturers to the API producers.

Typical intermediate supply needs in miltefosine synthesis

• protected or activated phosphorus-containing intermediates
• alkylation and coupling reagents used to build the miltefosine skeleton
• hydrogenation or purification-critical intermediates where impurity control matters

How this affects supplier selection

• buyers often qualify the API plant first and accept intermediate variability only if impurity and residual reagent limits are met in final API release
• for clinical supply, suppliers may requalify impurities and stability if synthesis route changes

Which finished-dose manufacturers rely on miltefosine API suppliers?

Featured-snippet answer: Finished-dose leishmaniasis products typically source miltefosine API and then develop/scale dosage strengths under CMO or internal manufacturing.

Finished-dose roles in the supply chain

• API purchase by the drug product manufacturer
• formulation and packaging, commonly under tablet or capsule-like dosage forms depending on market authorization
• release testing that depends on API impurity profile and residual solvents

CMO qualification requirements

• supplier-specific API change notification procedures
• ongoing IPC and release testing alignment
• audit readiness for EU GMP and US GMP expectations

What qualification, regulatory, and audit constraints limit miltefosine supplier options?

Featured-snippet answer: Supplier access is constrained by GMP status, regulatory documentation, impurity control, and change management.

Core qualification artifacts buyers require

• GMP certificates for API manufacture
• batch CoA with impurity panel and residual solvents
• stability data package and retest period justification
• DMF linkage (for US) or equivalent regulatory submission linkage (for EU and other jurisdictions)

Audit and change-control points

• traceability from raw materials and phosphorus reagents through final purification
• controls for genotoxic impurities where applicable
• change history for synthesis route, catalysts, solvents, and purification steps

What is the Orange Book or DMF status for miltefosine that affects supplier access?

Featured-snippet answer: Supplier regulatory access is driven by DMF or marketing authorization dossier linkage rather than Orange Book listings for the drug itself.

Why Orange Book is not the practical supplier filter

• Orange Book is a patent and exclusivity registry tied to approved drug products.
• Miltefosine supplier qualification is typically anchored to GMP and DMF/CMC dossier documentation.

Practical implication for procurement

• buyers align the API they plan to use with the dossier referenced by their regulatory strategy, often requiring DMF cross-referencing, letter of access, or ASMF/MAA alignment.

When do supply shortages or lead-time issues most often hit miltefosine procurement?

Featured-snippet answer: Lead-time risk is concentrated around API batch availability, seasonal manufacturing schedules, and plant capacity constraints at the small set of qualified producers.

Drivers of miltefosine supply disruption

• limited number of API-producing sites
• batch-to-batch schedule alignment with drug product manufacturing windows
• heightened impurity-spec scrutiny that triggers additional analytical release cycles

How does miltefosine supplier coverage compare across geographies (US, EU, India, ROW)?

Featured-snippet answer: Coverage is strongest where buyers have alternative distributors and where API plants support EU GMP and DMF-ready documentation.

Procurement reality by region

• US: emphasis on US-ready CMC documentation and DMF linkage to support submissions
• EU: emphasis on EU GMP, Qualified Person release support, and ASMF/MAA documentation alignment
• India and ROW: procurement often routes through local distributors and contract supply under qualification schedules

Key supplier-identification note

A precise, decision-grade list of specific miltefosine API suppliers requires confirmed, current sourcing evidence (manufacturing site, GMP scope, and product grade) from regulatory listings (DMF/ASMF), supplier qualification records, or verified procurement databases. Without that sourced validation, any named list risks including entities that do not supply miltefosine API to qualified pharmaceutical customers or do not operate under the claimed GMP scope.

Key Takeaways

• Miltefosine supply is concentrated in a narrow set of qualified API manufacturers and specialty distributors rather than a broad, commoditized ingredient market.
• Procurement hinges on GMP status, impurity control, stability package availability, and dossier linkage (DMF/ASMF/letter of access) more than catalog availability.
• Supplier selection and qualification must be planned around CMC timelines and release testing dependencies on API impurity profiles.

FAQs

1) What documents are typically required to qualify a miltefosine API supplier?
GMP certificate for API manufacture, CoA/impurity panel, stability package, residual solvent data, and dossier linkage artifacts (DMF/ASMF and letters of access or referencing rights).

2) Can miltefosine be sourced from non-pharmaceutical chemical suppliers?
Only if the supplier can provide pharmaceutical-grade material with full GMP and testing documentation suitable for drug-substance use.

3) How do API impurity specifications affect miltefosine drug product release?
Drug product release testing depends on the API impurity panel and residual solvent limits; out-of-spec impurities can delay batch release and trigger re-testing.

4) What is the most common procurement model for miltefosine?
Buyers typically use qualified distributors for batch availability and documentation bundling, or contract directly with the API manufacturer when dossier control and change-control requirements are strict.

5) What risks are highest when switching miltefosine API suppliers?
Synthesis route differences that shift impurity profiles, changes in residual solvents, altered stability behavior, and regulatory change-management friction.

References

1. None provided.