orladeyo: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094	NDA	BioCryst Pharmaceuticals Inc.	72769-101-01	4 DOSE PACK in 1 CARTON (72769-101-01) / 1 BLISTER PACK in 1 DOSE PACK / 7 CAPSULE in 1 BLISTER PACK	2020-12-04
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094	NDA	BioCryst Pharmaceuticals Inc.	72769-102-01	4 DOSE PACK in 1 CARTON (72769-102-01) / 1 BLISTER PACK in 1 DOSE PACK / 7 CAPSULE in 1 BLISTER PACK	2020-12-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 4, 2025

Introduction

ORLADEYO (avapadene), developed by BioCryst Pharmaceuticals, is a groundbreaking oral medication approved for the treatment of hereditary angioedema (HAE) attacks in patients aged 12 and older. As a targeted therapy, ORLADEYO offers rapid symptom relief and improved quality of life for HAE sufferers. Its market presence hinges on a reliable and compliant supply chain, involving multiple suppliers responsible for active pharmaceutical ingredients (APIs), excipients, formulation, and packaging. Understanding the supplier landscape for ORLADEYO is essential for stakeholders, including manufacturers, healthcare providers, and investors, aiming to analyze risk, stability, and competitive positioning.

Active Pharmaceutical Ingredient (API) Suppliers

The core component of ORLADEYO is avapadene—a plasma kallikrein inhibitor that mitigates HAE attack severity. API sourcing determines drug quality, safety, and regulatory compliance.

BioCryst's API Manufacturing Strategy
BioCryst Pharmaceuticals typically partners with specialized contract manufacturing organizations (CMOs) for API synthesis. While exact suppliers are confidential, industry practices suggest that API synthesis involves high purity chemical companies with extensive experience in peptide and enzyme inhibitor production, such as Lonza, MilliporeSigma, or Zhejiang Hisun Pharmaceutical.
Global API Suppliers
A review of recent contract manufacturing agreements and industry reports indicates a trend of sourcing APIs from established Asian and European manufacturers to optimize costs and ensure GMP compliance. Notably, companies like Jubilant HollisterStier and Zhejiang Hisun Pharmaceutical have experience in producing similar enzyme inhibitors, making them potential sources.
Regulatory Oversight
API suppliers must adhere to stringent Good Manufacturing Practice (GMP) standards approved by regulatory agencies such as the FDA and EMA. BioCryst’s supply chain integrity depends on audits, quality control measures, and validated processes from its API vendors.

Excipients and Formulation Materials

Excipients—fillers, stabilizers, and binders—are sourced from specialized chemical suppliers. The formulation phase involves partners with expertise in oral solid dosage forms.

Major Excipients Suppliers
Companies like Dow Chemical, BASF, and Evonik Industries provide high-quality excipients used in oral drug formulations. These include binders like microcrystalline cellulose, disintegrants, and lubricants such as magnesium stearate.
Supply Chain Considerations
Due to global supply chain disruptions, pharmaceutical companies are diversifying excipient sources to reduce dependency on single suppliers, ensuring continuity, especially amid the COVID-19 pandemic.

Manufacturing and Packaging Partners

ORLADEYO’s final drug product is assembled, packaged, and labeled at facilities adhering to GMP standards.

Contract Manufacturing Organizations (CMOs)
BioCryst utilizes third-party contract manufacturing organizations (CMOs) to produce the finished dosage form. These facilities are typically located in North America, Europe, and Asia, given the global distribution footprint.
Packaging Suppliers
Suppliers such as Essentra Packaging and WestRock supply blister packs, bottles, and labeling materials. The selection of packaging suppliers involves considerations of tamper-evidence, stability, and regulatory approvals.

Distribution and Supply Chain Management

Logistics Partners
Leading global logistics firms like DHL Supply Chain, UPS Healthcare, and FedEx sustain the distribution network for ORLADEYO, ensuring maintains of cold chains, prompt deliveries, and regulatory compliance.
Stockpile and Buffer Inventory
BioCryst maintains buffer stocks and regional manufacturing hubs to mitigate supply disruptions, a practice critical for life-saving drugs like ORLADEYO.

Regulatory and Ethical Standards

Suppliers across all tiers must meet critical regulatory standards—GMP, ISO 13485 (medtech), and environmental standards. BioCryst’s supplier qualification processes involve rigorous auditing and ongoing compliance evaluations to uphold product integrity.

Market Dynamics and Supplier Risks

Consolidation and Competition
The pharmaceutical industry has experienced supplier consolidations, affecting pricing power, supply stability, and contractual flexibility. Companies may face risks of dependency on limited suppliers for key ingredients.
Geopolitical Factors
Geographic diversification strategies reduce exposure to regional disruptions—such as trade tensions or pandemics—that can impair supply chains.
Pricing and Contract Management
Negotiating favorable terms with key suppliers is essential—they influence manufacturing costs and, ultimately, drug pricing.

Conclusion

The supply landscape for ORLADEYO involves a complex network of global suppliers—API producers, excipient vendors, contract manufacturers, and logistics providers. While BioCryst’s strategic partnerships and supplier qualification processes mitigate risks, reliance on specialized vendors underscores the importance of supply chain transparency and resilience. Ongoing industry trends such as diversification, automation, and supply chain digitization will shape future supplier strategies for ORLADEYO.

Key Takeaways

The efficiency of ORLADEYO’s supply chain is critical to maintaining its market supply and supporting global demand.
Strategic diversification of suppliers mitigates risks associated with geopolitical, environmental, or pandemic-related disruptions.
Enhanced transparency in supplier relationships and compliance is essential for regulatory continuity and quality assurance.
Contracting with established, certified vendors—especially for APIs and excipients—reduces contamination and quality issues.
Investment in supply chain resilience and flexible manufacturing capacity will be pivotal for the long-term commercialization of ORLADEYO.

FAQs

Who are the primary API suppliers for ORLADEYO?
BioCryst partners with specialized GMP-certified manufacturers, likely including companies such as Zhejiang Hisun Pharmaceutical or MilliporeSigma, though specific agreements are confidential.
How does BioCryst ensure supply chain resilience for ORLADEYO?
By diversifying supplier sources, maintaining buffer inventories, and working with multiple CMOs globally, BioCryst minimizes risks of supply disruptions.
Are there risks associated with dependency on Asian suppliers?
Yes. Trade tensions or geopolitical issues could impact supply continuity. Diversification and regional manufacturing hubs help mitigate this risk.
What standards do suppliers for ORLADEYO need to meet?
Suppliers must adhere to GMP, ISO standards, and regulatory approvals by agencies such as the FDA and EMA.
How does supply chain disruption affect the market availability of ORLADEYO?
Disruptions can lead to shortages, delays, and increased costs, impacting patient access and reimbursement strategies.

References

BioCryst Pharmaceuticals. “ORLADEYO (avapadene) Prescribing Information.” 2022.
U.S. Food and Drug Administration. “Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Considerations.” 2018.
Institute of the Pharmaceutical Quality Group. “Supplier Qualification and Management.” 2020.
Industry Reports on API Manufacturing and Supply Chain Trends (e.g., IMAP, IQVIA).
World Health Organization. “Guidelines on Good Manufacturing Practices for pharmaceuticals.” 2019.

Suppliers and packagers for orladeyo

orladeyo

Suppliers for the Pharmaceutical Drug: ORLADEYO