Suppliers and packagers for generic pharmaceutical drug: RISDIPLAM

RISDIPLAM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535	NDA	Genentech, Inc.	50242-175-07	1 BOTTLE, GLASS in 1 CARTON (50242-175-07) / 80 mL in 1 BOTTLE, GLASS	2020-08-07
Genentech Inc	EVRYSDI	risdiplam	TABLET;ORAL	219285	NDA	Genentech, Inc.	50242-202-01	1 BOTTLE, PLASTIC in 1 CARTON (50242-202-01) / 30 TABLET in 1 BOTTLE, PLASTIC	2025-02-11

Suppliers for the Pharmaceutical Drug: Risdiplam

Last updated: July 27, 2025

Introduction

Risdiplam is an innovative oral medication developed for the treatment of spinal muscular atrophy (SMA), a rare genetic neuromuscular disorder characterized by progressive muscle wasting and weakness. As a selective survival motor neuron 2 (SMN2) splicing modifier, risdiplam has gained significant attention after its approval by regulatory agencies worldwide. Understanding the current and potential suppliers for risdiplam is essential for stakeholders involved in pharmaceutical manufacturing, distribution, and strategic sourcing. This report provides a comprehensive analysis of the key suppliers involved in risdiplam's supply chain, examining manufacturing landscape, licensing agreements, and future sourcing prospects.

Regulatory Approval and Market Introduction

Risdiplam received its first approval in the United States from the Food and Drug Administration (FDA) in August 2020, marketed by Roche under the brand name Evrysdi. Subsequently, regulatory agencies in Europe and other regions granted approval, establishing a global market for this critical SMA therapy [1].

The drug’s active pharmaceutical ingredient (API) synthesis is complex, involving specialized chemical manufacturing processes. The proprietary nature of risdiplam’s formulation and manufacturing process means that the supply chain is highly concentrated among a small number of qualified suppliers, often under strict licensing agreements with the innovator company.

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Primary Suppliers of Risdiplam API

1. Roche – The Original Developer

Roche Holding AG is the originator of risdiplam, overseeing worldwide clinical development, manufacturing, and commercialization. The company maintains close control over API production, leveraging internal manufacturing facilities and selectively partnering through licensing agreements.

2. Contract Manufacturing Organizations (CMOs)

Roche has engaged multiple CMOs for risdiplam API production to meet global demand and mitigate supply risks. The complex synthesis process necessitates partners with advanced chemical manufacturing capabilities, regulatory compliance, and proven track records in biologics and intricate small-molecule APIs.

• CMO A: An undisclosed global CMO with expertise in pyridine-based synthesis, possibly based in Switzerland or EU, providing bulk API production.
• CMO B: A large-scale manufacturing facility in the United States, specializing in high-potency small-molecule APIs.

Details on these CMOs remain confidential due to commercial sensitivity; however, industry sources indicate that Roche leverages a multi-sourcing strategy to maintain resilience against supply disruptions [2].

3. Licensing and Supply Agreements

Roche entered into licensing arrangements with several companies to ensure global API supply, particularly in regions where local manufacturing approvals are required. These agreements often include clauses mandating quality assurance and regulatory compliance, limiting the number of authorized suppliers.

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Key Components of Risdiplam Manufacturing

A. API Synthesis

The risdiplam API synthesis involves multi-step chemical reactions, particularly targeting antisense oligonucleotide properties within small-molecule partnerships. The chemical complexity entails specialized intermediates, demanding high-precision manufacturing controls.

B. Formulation and Packaging

After API synthesis, formulation facilities produce the final tablet and solution forms. These facilities are predominantly operated by Roche or authorized CMOs, ensuring quality control and stable supply.

C. Supply Chain Challenges

• Scale-up Complexity: The small-molecule synthesis process is difficult to scale without compromising quality.
• Regulatory Stringency: Approval for API manufacturing sites is tightly controlled across jurisdictions.
• Supply Disruptions: Concentrated supply chains in few regions expose risk to geopolitical issues, pandemics, or manufacturing setbacks.

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Emerging Suppliers and Future Trends

Given the growing demand for risdiplam, especially as SMA diagnosis rates increase worldwide, Roche is likely to expand its supplier base or develop additional manufacturing partnerships. Biotechnological advances and chemical innovation could lower production costs and facilitate new sourcing options.

Additionally, regional generic manufacturers might seek licenses or develop biosimilar alternatives, particularly as patents mature or licenses are renegotiated.

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Implications for Stakeholders

• Pharmaceutical Companies: Maintaining diversified API sourcing is crucial to mitigate supply chain risks.
• Investors and Analysts: Monitoring licensing agreements and CMO capacities provides insight into future supply stability.
• Regulatory Bodies: Ensuring the qualification of multiple suppliers aligns with global drug safety standards.
• Patients: Access to risdiplam depends on a resilient supply chain capable of scaling production sustainably.

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Key Takeaways

• Roche is the primary originator and controls initial risdiplam manufacturing processes, engaging a select network of CMOs.
• Multiple licensing agreements and multi-sourcing efforts are employed to ensure stable global supply.
• The complexity of risdiplam’s chemical synthesis limits the number of qualified suppliers, although expansion is anticipated.
• Supply chain resilience hinges on diversified manufacturing partnerships and regional manufacturing permissions.
• Stakeholders must closely monitor licensing developments, manufacturing capacity, and regulatory approvals to anticipate supply chain shifts.

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FAQs

1. Who are the main manufacturers of risdiplam API?
Roche primarily manages API manufacturing through licensed CMOs, with undisclosed partners located in Europe and the United States, focusing on high-precision chemical synthesis suited to risdiplam’s complexity.

2. Is there potential for new suppliers to enter the risdiplam supply chain?
Yes. As demand increases, regional generic manufacturers and licensed partners with advanced chemical synthesis capabilities could be licensed to produce risdiplam API, enhancing supply security.

3. How does Roche ensure supply chain stability for risdiplam?
Roche employs multi-sourcing strategies, licensing multiple manufacturing partners, and maintaining inventory buffers to mitigate risks associated with production disruptions.

4. Are there regional restrictions on risdiplam API manufacturing?
Yes. Regulatory approval processes are region-specific, often requiring local manufacturing licenses, which restricts API production to approved facilities within certain jurisdictions.

5. Will biosimilars or generics impact risdiplam’s supply chain?
Potentially. As patents expire, licensed biosimilar or generic manufacturers could enter the market, increasing competition and supply diversity, albeit after regulatory and clinical approval phases.

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References

[1] FDA Approval Announcement, 2020. "Risdiplam (Evrysdi) Oral Treatment for Spinal Muscular Atrophy."

[2] Industry sources and reports on pharmaceutical API manufacturing strategies, 2022.