Suppliers and packagers for RYDAPT

RYDAPT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997	NDA	Novartis Pharmaceuticals Corporation	0078-0698-19	4 CARTON in 1 CARTON (0078-0698-19) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02)	2017-04-28
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997	NDA	Novartis Pharmaceuticals Corporation	0078-0698-99	2 CARTON in 1 CARTON (0078-0698-99) / 14 BLISTER PACK in 1 CARTON (0078-0698-51) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0698-02)	2017-04-28

Rydapt (midostaurin) Suppliers: Who Makes the API, Key Excipients, and Finished Dosage Forms and What to Check in Drug Master Files

Last updated: May 30, 2026

Rydapt’s upstream supply chain is centered on midostaurin active pharmaceutical ingredient (API) and finished oral capsule manufacture. Public, source-verifiable “supplier” identification (by company name mapped to API vs. finished dose) is not consistently disclosed in open databases. What can be stated with action-grade specificity is what buyers should verify in regulatory and contract manufacturing due diligence: API sourcing controls, intermediate/manufacturing sites, drug master file (DMF) holders, capsule filling/packaging plants, and Orange Book listing particulars.

Who supplies Rydapt (midostaurin) API and finished capsules?

Bottom line: Rydapt supply is governed by (1) midostaurin API manufacturing (including polymorph and impurity specs) and (2) finished-dose capsule filling and packaging under Novartis quality systems. For supplier identification at a name-by-name level, buyers typically need to review Orange Book manufacturing information, NDA CMC supplements, and DMF cross-references tied to the label’s listed manufacturers.

What to verify in the Orange Book and FDA labeling

Orange Book and FDA labeling can indicate:

• Listed manufacturers for the finished product (capsules)
• Strength-specific marketing authorization holders
• Whether a facility is for drug product, not necessarily API
• Changes from CMC supplements that shift manufacturing sites over time

Procurement due diligence checklist for “supplier” mapping

• Does the midostaurin API come from a named listed manufacturer or from a referenced DMF?
• Are there multiple DMF holders for the same API, implying dual sourcing?
• Are drug product manufacturing steps (capsule fill, capping, inspection, packaging) performed at one site or multiple?
• Are there late-stage site transfers that could constrain near-term capacity?

Midostaurin API supply chain controls that drive supplier selection

For oncology APIs like midostaurin, supplier qualification usually hinges on:

• Batch traceability and impurity profile control (process-related impurities and residual solvents)
• Crystal form/polymorph control and stability of the solid state
• Scale-up comparability between early and commercial campaigns
• Documentation readiness for change control (CMC reporting categories and comparability protocols)

What suppliers are listed for Rydapt drug product (capsules) and how do sites change?

Bottom line: Finished-dose “suppliers” are typically the NDA-listed manufacturers and packaging facilities named in FDA systems. Site changes are common across lifecycle management, so buyers should validate the specific strength and NDC at purchase time.

Which manufacturing steps matter for vendor risk

Even when a vendor is “listed,” procurement risk often sits in the step that is not outsourced:

• Encapsulation (filling and capping) capacity and line clearance capability
• Blistering or bottle packaging equipment qualification
• Photostability handling and temperature/humidity controls for packaging windows
• Serialization and label control

How to distinguish API vendor vs. drug product vendor

• API vendors are usually DMF holders or referenced in CMC documentation.
• Drug product vendors are usually the listed facilities for capsules/blister/bottled packaging.

If a vendor contract is framed as “we supply Rydapt,” the buyer should confirm whether the supplier is providing:

• Material for encapsulation (finished API or intermediates), or
• Finished capsules (drug product), or
• Both.

How to identify DMF holders and API manufacturing sites for Rydapt (midostaurin)

Bottom line: DMF holders for midostaurin are the most direct “API supplier” proxy when Orange Book does not enumerate the API manufacturing company name.

DMF types that change what you get from the supplier

• Type II (drug substance): API manufacturing site and process documentation
• Type III (drug product): less likely for typical outsourced solid oral manufacturing, but can exist
• Type IV (chemical development): stability and formulation-relevant documentation

What procurement teams should request in a DMF cross-reference audit

• DMF number and current holder name
• Manufacturing site addresses aligned to certificates of analysis (CoAs)
• Status: active references, amendments submitted, and reporting history
• Any cross-site transfers affecting process validation and impurity limits

Which companies make midostaurin API for Rydapt and competitor products?

Bottom line: Midostaurin API supply can be shared across branded and generic-facing markets, but direct public mappings to “who makes midostaurin for Rydapt” are not consistently published in a form that supports a reliable named-supplier list.

Competitive positioning that affects supplier availability

Midostaurin is a niche oncology API. Supplier landscape tends to be shaped by:

• Batch size economics and campaign-based production
• Regulatory inspection outcomes at specific API plants
• Ability to deliver consistent solid state and impurity control
• Readiness for rapid supply in shortages

What buyers should check when qualifying alternative midostaurin suppliers

• Demonstrated experience with oncology small molecules and regulatory expectations for impurity profiles
• Compliance history for GMP and data integrity at the API site
• Capability to supply under R&D supply terms (stability and analytical method transfer)

Does Rydapt rely on single-source midostaurin API or multiple suppliers?

Bottom line: Whether supply is single- or multi-sourced depends on NDA CMC submissions and internal supply chain redundancy, which are not fully reconstructible from public snippets alone.

How multi-sourcing shows up in regulatory records

Signals include:

• Multiple API manufacturing sites referenced over time
• Multiple DMF holders or active DMF amendments
• Multiple drug product facilities listed for the same NDC/strength over different periods

What excipient and capsule shell suppliers matter for Rydapt?

Bottom line: For solid oral capsule products, excipient and capsule shell supply are often handled under Novartis specifications and approved raw material controls. Public disclosure of capsule shell suppliers is uncommon.

Where supplier identity matters most

Procurement risk concentrates on:

• Capsule shell material consistency (gelatin vs. alternative shells if used)
• Opacifier/ink components if labeling is integrated
• Moisture control excipients if the formulation uses hygroscopic components

What FDA regulatory status affects who can supply Rydapt?

Bottom line: Rydapt is an FDA-approved brand. Regulatory constraints for supplying copies do not directly prevent contract manufacturing of midostaurin API, but they do drive:

• Facility qualification requirements
• Analytical method alignment and CoA release standards
• Post-approval changes reporting obligations

How FDA chemistry manufacturing controls limit vendor substitution

Any substitute requires:

• Demonstrated comparability
• Stability and performance testing
• CMC reporting pathway compliance (prior approval supplement vs. changes being effected categories, depending on the change type)

Key Takeaways

• “Suppliers for Rydapt” splits into two different procurement targets: midostaurin API and finished-dose capsule manufacturing.
• The most reliable route to name-by-name supplier identification is Orange Book manufacturing listings for the finished product plus DMF cross-reference review for the API.
• Vendor qualification for midostaurin is driven by solid-state and impurity control, GMP data integrity, and ability to support CMC change control.

FAQs

1) Can I identify Rydapt API suppliers from Orange Book alone?
No. Orange Book commonly lists drug product manufacturers tied to NDA marketing authorization, not necessarily the API DMF holder.

2) What documents show midostaurin API manufacturing sites?
NDA CMC sections and DMF cross-references are the primary sources that map to API manufacturing sites.

3) Do Rydapt capsule manufacturers change over time?
Yes. Facility transfers and packaging line qualification changes can occur across lifecycle management, so procurement should validate NDC-level manufacturer details.

4) What supplier risks matter most for midostaurin oncology APIs?
Solid-state control, impurity profile consistency, and GMP inspection outcomes at the API site.

5) Can alternative suppliers provide Rydapt capsules without an FDA filing?
Capsule supply as contract manufacturing requires that the finished product meets NDA CMC expectations. Substituting supply chain steps typically triggers CMC comparability and reporting requirements.

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References (APA)

No cited sources were provided in the prompt.