Suppliers and packagers for generic pharmaceutical drug: midostaurin

midostaurin

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

Suppliers for the Pharmaceutical Drug: MIDOSTAURIN

Last updated: July 28, 2025

Introduction

Midostaurin, commercially branded as Rydapt by Novartis, is an oral kinase inhibitor approved primarily for treating specific blood cancers, including acute myeloid leukemia (AML) with FLT3 mutations and systemic mastocytosis. Since its initial approval, availability and sourcing have become critical for healthcare providers, research institutions, and pharmaceutical distributors seeking quality-assured suppliers. This report provides a comprehensive overview of the primary suppliers of midostaurin, including authorized manufacturers, authorized distributors, and potential regulatory considerations for procurement.

Manufacturers of Midostaurin

Original Manufacturer: Novartis

Novartis Pharmaceuticals Corporation holds the patent and manufacturing rights for midostaurin, having developed and obtained regulatory approval for its commercial formulation. Since its approval by the U.S. Food and Drug Administration (FDA) in 2017, Novartis has been the primary, authorized producer. As the originator, Novartis ensures that the drug adheres to strict quality control standards, including Good Manufacturing Practices (GMP), and supplies it primarily to licensed pharmacies and healthcare providers.

Contracted Manufacturing and Supply Chain

While Novartis is the sole patent holder and primary manufacturer, manufacturing expertise often involves contract manufacturing organizations (CMOs). These CMOs are authorized cGMP-compliant facilities responsible for producing bulk midostaurin, which is then formulated and packaged by Novartis or its partners. Such arrangements enable scaling supply to meet global demand while maintaining quality standards.

Generic Manufacturers

As original patent protections expire or if patent litigations are resolved in favor of generics, other manufacturers may seek approval to produce authorized generics or biosimilar versions. Currently, no licensed generic version of midostaurin has been approved or marketed, although some Asian pharmaceutical companies are reported to hold investigational or regional rights pending regulatory approval. Potential future suppliers could include:

• Sun Pharmaceutical Industries
• Dr. Reddy’s Laboratories
• Zhejiang Hisun Pharmaceutical Co.
• Cipla Ltd.

However, these companies are yet to receive regulatory authorization for wave-specific manufacturing of midostaurin.

Authorized Distributors and Supply Channels

Global Distribution

Healthcare institutions and pharmacies typically procure midostaurin through authorized distribution networks licensed by Novartis or regional regulatory agencies. These include:

• Centralized Pharmaceutical Distributors: Large entities like McKesson, Cardinal Health, or AmerisourceBergen facilitate bulk procurement and distribution for hospitals in North America and Europe.
• Regional Distributors: Regional players often serve specific markets, ensuring compliance with local regulatory standards. These distributors maintain GAPs quality certifications and uphold secure supply chains.

Specialty and Oncology Pharmacists

Specialty pharmacy providers are critical in ensuring appropriate handling, storage, and patient access. They source midostaurin directly from licensed distributors, maintaining controlled distribution channels compliant with regulatory requirements. These providers often serve as the primary point of procurement for hospitals and outpatient clinics.

Online and International Marketplaces

While some online platforms may claim to supply midostaurin, reliance on unauthorized sources entails significant risk, including counterfeit products, substandard quality, and legal repercussions. Therefore, procurement must prioritize sources vetted by regulatory agencies such as the FDA or EMA.

Regulatory and Quality Considerations

Obtaining midostaurin from authorized, licensed sources ensures product authenticity and compliance with quality standards. The drug's complex synthesis necessitates stringent manufacturing control to guarantee purity and potency. Regulatory agencies, including the FDA, EMA, and respective national authorities, strictly regulate manufacturing and distribution channels for prescription oncology medications.

Countries with regulatory pathways for generic or biosimilar drugs may approve alternative suppliers once patents expire or through biosimilar pathways. Such approvals require comprehensive bioequivalence and clinical data. Until then, Novartis remains the exclusive source in many markets.

Emerging Supply Dynamics

Biosimilar and Generic Approvals

As patent exclusivity diminishes, competition may increase. Some emerging markets have initiated biosimilar development programs. For example:

• Indian and Chinese pharmaceutical firms are actively developing potential biosimilars or generics, with some in late-stage clinical trials or regulatory review.
• Regulatory authorities such as the Drugs Controller General of India (DCGI) may approve biosimilar midostaurin formulations, expanding supply options.

Global Supply Chain Risks

Production disruptions, regulatory delays, or patent litigation can influence supply availability. The COVID-19 pandemic highlighted vulnerabilities in global supply chains, emphasizing the importance of diversified sourcing and inventory management.

Key Challenges in Sourcing Midostaurin

• Limited number of authorized manufacturers: Currently, only Novartis holds regulatory approval for the marketed drug.
• Potential for counterfeit or substandard products: Unauthorized online sources pose significant risks.
• Regional regulatory barriers: Import restrictions or lack of local approvals can limit access.
• Supply chain disruptions: External factors such as manufacturing delays or geopolitical issues.

Future Outlook

The patent expiration or settlement could pave the way for licensed biosimilar manufacturers, increasing supply options and reducing costs. Meanwhile, healthcare providers should prioritize sourcing from certified distributors to ensure product integrity. Regulatory agencies are expected to progressively approve alternative suppliers, expanding the global supply footprint.

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Key Takeaways

• Novartis is the exclusive original manufacturer of midostaurin, with most supply controlled through authorized distributors following strict GMP standards.
• No licensed generic or biosimilar versions are currently approved, but developments are ongoing, especially in Asian markets.
• Reliable procurement should always involve authorized, licensed distributors and specialty pharmacies to mitigate risks associated with counterfeit products.
• Regulatory pathways are critical for expanding supplier options, with biosimilars likely to increase competition in the coming years.
• Supply chain resilience and vigilant sourcing practices remain vital for ensuring the consistent availability of high-quality midostaurin.

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FAQs

1. Is midostaurin available from generic manufacturers?
Currently, no generic versions of midostaurin have received regulatory approval. The drug remains under patent protection with Novartis as the sole authorized producer. However, biosimilar development is progressing in some regions, which may bring alternative options in the future.

2. How can healthcare providers ensure the authenticity of midostaurin supplies?
Procure solely from authorized distributors and licensed pharmacies with verified Good Manufacturing Practices (GMP) certification. Verify supply chain documentation and cross-reference with regulatory databases to avoid counterfeits.

3. Are there regional differences in midostaurin supply approval?
Yes. While the FDA and EMA have approved midostaurin, approval and availability can vary significantly in emerging markets. Local agencies may be in the process of approving biosimilars or generics once patent rights expire.

4. Can online platforms be a safe source of midostaurin?
No, online platforms not approved by regulatory authorities pose risks of counterfeit, substandard, or expired products. Always source from licensed providers to ensure safety and efficacy.

5. What are the prospects for biosimilars of midostaurin?
Biosimilar development efforts are underway, especially in India, China, and other regions. Regulatory approval timelines are uncertain but are expected to increase supply options and reduce costs over the next several years.

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Sources

[1] U.S. Food and Drug Administration. (2017). "FDA approval of Rydapt (midostaurin) for acute myeloid leukemia."
[2] Novartis AG. (2022). "Product information for Rydapt (midostaurin)."
[3] European Medicines Agency. (2022). "Medicines—Midostaurin (Rydapt)."
[4] ClinicalTrials.gov. "Biosimilar development for kinase inhibitors."
[5] Indian Drug Regulatory Authority (DCGI). "Guidelines for biosimilar approval."