Suppliers and packagers for impavido

impavido

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

Suppliers and packagers for impavido

Last updated: June 6, 2026

Suppliers for IMPAVIDO (miltefosine) capsules: Who manufactures, supplies APIs, and how the supply chain is mapped

IMPAVIDO is miltefosine, an oral antiprotozoal. Supplier identification hinges on the FDA label supply-chain statements and the Orange Book listing for IMPAVIDO (miltefosine) capsules, including listed manufacturers for the finished drug product and the API source, when disclosed.

Who supplies IMPAVIDO (miltefosine) capsules in the US market?

IMPAVIDO is marketed in the US by Krysa Pharmaceutical, Inc. (per US labeling). The FDA label also identifies the commercial drug product manufacturer(s) responsible for supply of the finished dosage form.

What entities appear on the IMPAVIDO US prescribing information for manufacturing/supply?

Key labeling fields to map suppliers:

• Applicant/label holder (marketing authorization holder in the US)
• Manufacturer of the finished drug product (site-level manufacturing label statement)
• Any distributor listed for US commercial supply

How to confirm the finished-dose supplier from regulatory records

The finished-dose supplier for IMPAVIDO is confirmed via:

• FDA Orange Book listing entries for miltefosine (drug product, dosage form, strength) including “Applicant” and “Manufacturer” fields
• FDA prescribing information (US label) “Manufactured for” / “Distributed by” lines

What patents and Orange Book listings affect IMPAVIDO supply and supplier diversification?

Supplier churn in generics and contract manufacturing can follow IP and regulatory status, not the patent text itself. The Orange Book listing dictates whether manufacturers can legally market “same drug” versions and whether new entrants face litigation risk under Hatch-Waxman.

What is the Orange Book status of IMPAVIDO (miltefosine) capsules?

Orange Book status is determined by:

• Listed drug designation
• Patent list (drug substance and formulation/method-of-use)
• Patent expiration and pediatric exclusivity flags
• Exclusivity blocks that prevent AB-rated generics even if a facility can manufacture

Which generic or biosimilar pathways exist for miltefosine, and what does that mean for IMPAVIDO suppliers?

IMPAVIDO is a small-molecule drug. The competitive entry risk for additional suppliers is generally via:

• ANDA for a generic “miltefosine” capsule product
• If any route exists with a new dosage form, it is typically a formulation-specific ANDA

What generic entry risks exist for IMPAVIDO?

Generic entry timing depends on:

• Patent expirations and any Orange Book exclusivity blocks
• Whether any Paragraph IV filings target the listed patents
• Settlement terms if litigation is filed

Are there supplier constraints for miltefosine API that limit IMPAVIDO manufacturers?

For small-molecule anti-infectives, supplier constraints typically come from:

• API sourcing and control strategy
• GMP manufacturing capacity at the API site
• Impurity profiles tied to specific synthetic routes
• Any regulatory history of manufacturing site findings

How API sourcing can be traced for IMPAVIDO

API supplier identification in US regulatory documentation is often limited, but the practical trace sources are:

• Orange Book drug substance patent assignee and related manufacturing references (not always the actual API supplier)
• Label “manufactured by” site statements for finished product
• Public supplier catalogs and DMF references where disclosed (DMF linkage to the NDA does not always identify the API site by name)

How does IMPAVIDO’s supply chain typically break down (finished product vs API vs packaging)?

A standard mapping for an FDA-labeled small molecule like miltefosine is:

• API manufacture (miltefosine active)
• Drug product manufacture (capsule fill and finish)
• Secondary packaging and distribution

What contract manufacturing roles commonly appear

• API tolling or contract manufacture under a controlled DMF or site-specific sourcing
• Drug product CMOs producing capsules under GMP and controlled label configuration
• Packaging suppliers for blistering or bottle packaging depending on market configuration

Which companies are likely involved as suppliers for IMPAVIDO?

A high-integrity supplier list requires extracting the exact “manufactured for” and Orange Book manufacturer entries for the IMPAVIDO listed drug record.

Supplier list structure (what should be recorded)

For each supplier record, the actionable fields are:

• Role: finished drug product vs packaging vs distributor
• Legal entity name shown on label/Orange Book
• Manufacturing site address (when shown)
• Country
• Regulatory linkage (Orange Book manufacturer field, label “manufactured for/distributed by” lines)

What IMPAVIDO supply risks matter for contracting and continuity planning?

Supply risk is typically driven by:

• Single-site dependence for capsule manufacturing
• Limited API capacity for miltefosine
• Regulatory compliance events at either API or finished product sites
• Lead times for packaging components

What to monitor in regulatory releases and inspections

• FDA inspection outcomes for the labeled manufacturer sites
• Field safety actions or product discontinuations
• Orange Book record edits indicating supplier changes

Key Takeaways

• Supplier identification for IMPAVIDO requires matching the US label manufacturer/distributor lines with the FDA Orange Book “Manufacturer” fields for the IMPAVIDO (miltefosine) capsules listed drug.
• The supplier landscape can only be stated accurately when the specific Orange Book entry and the exact label manufacturing/distribution statements are used as the source of record.
• Supply continuity planning should focus on single-site finished-dose manufacturing dependence and any API capacity constraints that can propagate into drug product delays.

FAQs

1. What are the listed manufacturers for IMPAVIDO (miltefosine) in the FDA Orange Book?
2. Who is the US label holder for IMPAVIDO, and how is it listed on the prescribing information?
3. Do IMPAVIDO manufacturers change after NDA/label updates or facility transfers?
4. Are there any generic miltefosine ANDA suppliers approved that could affect IMPAVIDO supply?
5. How can contract manufacturing for miltefosine capsules be identified from public FDA records?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (miltefosine; IMPAVIDO listed drug record). US FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. FDA. IMPAVIDO (miltefosine) prescribing information (label manufacturer/distributor statements). US FDA. https://www.accessdata.fda.gov/scripts/cder/daf/