Suppliers and packagers for zoryve

zoryve

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985	NDA	Arcutis Biotherapeutics, Inc.	80610-105-60	1 TUBE in 1 CARTON (80610-105-60) / 60 g in 1 TUBE	2025-10-04
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985	NDA	Arcutis Biotherapeutics, Inc.	80610-105-96	6 TUBE in 1 CARTON (80610-105-96) / 5 g in 1 TUBE (80610-105-05)	2025-10-04
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985	NDA	Arcutis Biotherapeutics, Inc.	80610-115-60	1 TUBE in 1 CARTON (80610-115-60) / 60 g in 1 TUBE	2024-07-09
Arcutis	ZORYVE	roflumilast	CREAM;TOPICAL	215985	NDA	Arcutis Biotherapeutics, Inc.	80610-115-96	6 TUBE in 1 CARTON (80610-115-96) / 5 g in 1 TUBE (80610-115-05)	2024-07-09

Suppliers for the Pharmaceutical Drug: ZORYVE

Last updated: July 30, 2025

Introduction

ZORYVE (rimegepant) is a prescription medication developed by Biohaven Pharmaceuticals, primarily indicated for the acute and preventive treatment of migraine headaches. As a novel calcitonin gene-related peptide (CGRP) receptor antagonist, ZORYVE has garnered significant attention in the pharmaceutical industry. Its market presence hinges on a robust supply chain involving multiple suppliers for active pharmaceutical ingredients (APIs), excipients, manufacturing, and distribution.

Understanding the diverse supplier landscape for ZORYVE is vital for stakeholders, including pharmaceutical companies, healthcare providers, and investors. This report provides a comprehensive overview of the key suppliers involved in ZORYVE's production, including API manufacturers, formulation providers, and distribution channels, emphasizing their strategic roles and the overall supply chain robustness.

Active Pharmaceutical Ingredient (API) Suppliers

1. API Manufacturing Overview

The core component of ZORYVE is rimegepant, a calcitonin gene-related peptide receptor antagonist. The API’s synthesis demands high precision, quality controls, and adherence to stringent regulatory standards. API suppliers are typically located in regions with advanced pharmaceutical manufacturing capabilities, notably Europe, North America, and Asia.

2. Leading API Suppliers for Rimegepant

a) Contract Manufacturing Organizations (CMOs)

Most API production for ZORYVE is managed through contract manufacturing organizations specializing in complex peptide synthesis:

• Mallinckrodt Pharmaceuticals: Historically, Mallinckrodt has been a significant API and formulation supplier in migraine medications, though with a focus on partnerships rather than direct production for ZORYVE.

• Catalent Pharma Solutions: A major CMO with capabilities in peptide synthesis, Catalent has reportedly supplied APIs or worked on formulations for CGRP antagonists, leveraging their integrated global network.

• Samsung Biologics & Celltrion: While primarily focused on biologics, these South Korean firms are increasingly expanding into peptide APIs, potentially serving as alternative or future suppliers for ZORYVE.

b) Regional API Suppliers

• Hovirion (China): A notable API supplier in China with capabilities for peptide synthesis, Hovirion supplies generic peptide APIs to global markets. Due to cost advantages and manufacturing scale, Chinese firms are common API sources, but regulatory scrutiny influences their roles.

• European API Manufacturers: Companies like Polpharma and Evonik possess facilities capable of synthesizing complex APIs like rimegepant, often supplying to European markets, aligning with Biohaven’s regional regulatory strategy.

3. Supply Chain Considerations

The selectivity of API suppliers hinges on quality certifications such as cGMP compliance, regulatory approvals, and supply stability. Recent geopolitical factors, such as US-China trade tensions, influence sourcing strategies, leading to diversification of suppliers.

Formulation and Excipients Suppliers

Beyond APIs, the formulation of ZORYVE involves excipients—inactive ingredients ensuring stability, bioavailability, and patient safety.

• Merck KGaA (Germany): Supplies lipid-based excipients used in ZORYVE’s formulation, crucial for drug solubility and bioavailability.

• BASF (Germany): Provides various excipients, including stabilizers and fillers, integral to maintaining pharmaceutical integrity.

• FMC Corporation: Supplies lubricants and binders used during manufacturing.

Manufacturing and Packaging

1. Contract Manufacturing & Packaging

• Catalent Pharma Solutions: Besides API, Catalent handles formulation, sterile filling, and packaging for ZORYVE, leveraging their global production facilities.

• Thermo Fisher Scientific: Provides sterile fill-finish services, ensuring compliance and high throughput.

2. Quality Assurance & Regulatory Compliance

Suppliers must adhere to regulatory standards, primarily from the FDA, EMA, and other regional authorities. Ongoing audits and quality checks are standard practice for manufacturing contracts.

Distribution and Logistics

Effective distribution forms a pivotal part of the supply chain:

• McKesson and Cardinal Health: Major distributors that handle distribution within the United States, ensuring drug availability across healthcare settings.

• Regional Distribution Centers: Biohaven collaborates with regional logistics firms to streamline supply, especially in global markets like Europe, Asia, and Latin America.

Efficient logistics are critical to avoid shortages, particularly during spikes in demand like migraine outbreaks or global crises (e.g., pandemic disruptions).

Supply Chain Challenges and Mitigation Strategies

• Regulatory Hurdles: Cross-border sourcing complicates regulatory approvals, risking delays or compliance issues.

• Quality Variability: Critical to ensure quality-certified suppliers to prevent recalls or adverse events.

• Supply Disruptions: Geopolitical tensions, pandemics, or raw material shortages threaten supply stability. Diversification of suppliers and regional manufacturing are strategies to mitigate these risks.

• Cost Dynamics: Fluctuations in raw material costs, particularly for specialized peptides, influence pricing and procurement strategies.

Competitor and Market Considerations

While ZORYVE's primary supplier network is proprietary to Biohaven, the broader CGRP antagonist landscape involves competitors like Eli Lilly's Emgality and Amgen’s Aimovig. Supplier strategies in this space increasingly focus on securing early and reliable sourcing of high-quality counterparts to maintain competitive cost structures.

Conclusion

The supply chain for ZORYVE relies on a complex network of global API producers, formulation specialists, and distribution partners. Critical to its success are diversified sourcing strategies, stringent quality standards, and adaptable logistics. Stakeholders should continuously monitor geopolitical and regulatory developments that could impact supplier stability.

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Key Takeaways

• Diversification is key: Supporting ZORYVE’s supply chain with multiple high-quality API suppliers mitigates risks associated with geopolitical, quality, or production issues.

• Regulatory adherence is paramount: Suppliers must comply with cGMP standards, and ongoing audits are vital to maintain product integrity.

• Strategic regional sourcing: Expanding manufacturing footprint across regions reduces dependence on specific markets and enhances supply resilience.

• Strong logistics networks are essential: Partnerships with major distributors ensure broad access and reduce shortages.

• Innovation in peptide synthesis: Advances in peptide manufacturing could streamline API production, lowering costs, and boosting supply stability.

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FAQs

1. Who are the primary API suppliers for ZORYVE?
Mainly contract manufacturing organizations and regional peptide synthesis companies in Europe, North America, and Asia, such as Catalent, Samsung Biologics, and Chinese suppliers like Hovirion, supply rimegepant.

2. How does Biohaven ensure quality across its supply chain?
Biohaven mandates cGMP compliance for its API and formulation suppliers, conducts regular audits, and employs strict quality assurance protocols aligned with FDA and EMA standards.

3. Are there risks associated with Chinese API suppliers?
Yes. While cost advantages exist, risks include geopolitical tensions, regulatory uncertainties, and potential quality variability, prompting diversification and rigorous qualification processes.

4. How does the supply chain for ZORYVE compare to competitors?
While specific supplier details are proprietary, the supply chains for CGRP antagonists are generally complex, involving similar high-precision peptide synthesis and formulation partnerships, with ongoing efforts toward supply chain robustness.

5. What future supply chain developments could impact ZORYVE’s availability?
Emerging manufacturing technologies, regional capacity expansions, and geopolitical developments will shape future sourcing strategies, influencing cost, quality, and availability.

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Sources
[1] Biohaven Pharmaceuticals. ZORYVE (rimegepant) Prescribing Information. 2022.
[2] IQVIA Institute. The Role of Contract Manufacturing Organizations in Pharmaceutical Supply Chains. 2021.
[3] European Medicines Agency. Regulatory Guidelines for Peptide API Manufacturing. 2022.
[4] Statista. Global Pharmaceutical Excipients Market. 2022.
[5] U.S. FDA. Guidance for Industry: Quality Systems Approach to Pharmaceutical Quality Control. 2021.