DAYBUE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acadia Pharms Inc	DAYBUE	trofinetide	SOLUTION;ORAL	217026	NDA	Acadia Pharmaceuticals Inc.	63090-660-01	1 BOTTLE, PLASTIC in 1 CARTON (63090-660-01) / 450 mL in 1 BOTTLE, PLASTIC	2023-03-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

Daybue (clobazam) has emerged as a significant pharmaceutical product primarily used in the treatment of rare epileptic conditions. Its unique therapeutic profile necessitates an efficient and reliable supply chain to meet rising clinical demands. This article delves into the landscape of suppliers for Daybue, exploring manufacturing sources, distribution channels, regulatory considerations, and strategic partnerships. Understanding these elements is crucial for healthcare providers, investors, and stakeholders navigating the complex pharmaceutical supply ecosystem.

Overview of Daybue (Clobazam)

Daybue, marketed under the generic name clobazam, is a benzodiazepine-class medication approved by the U.S. Food and Drug Administration (FDA) for specific neurological conditions such as Lennox-Gastaut syndrome (LGS). Under the brand name Daybue, it was introduced in 2022 by UCB Pharma, highlighting its role in addressing unmet needs in epilepsy management. Its administration requires precise dosing, and supply chain integrity is essential for ensuring consistent patient access.

Manufacturers of Clobazam for Daybue

UCB Pharma: The Original Manufacturer

UCB Pharma holds the rights to produce and commercialize Daybue. Their manufacturing operations span multiple facilities globally, with quality control and regulatory compliance serving as core priorities. UCB sources active pharmaceutical ingredients (APIs) and finished formulations from strategic suppliers to maintain product integrity. As the originator, UCB’s global production capacity heavily influences the drug's availability.

Contract Manufacturing Organizations (CMOs)

In some cases, patent-holding pharmaceutical companies partner with CMOs for bulk manufacturing to scale production and optimize costs. These CMOs adhere to Good Manufacturing Practices (GMP) and are typically approved by regulatory agencies like the FDA and EMA.

Generic Manufacturers

While Daybue is a branded product, generic versions of clobazam are produced by multiple manufacturers. Notable producers include:

Elder Pharmaceuticals (India)
Meda Pharmaceuticals (Sweden)
Glenmark Pharmaceuticals (India)
Mylan (international)

These generic suppliers provide APIs and formulation components, often supplying hospitals and pharmacies worldwide.

Supply Chain Components and Key Suppliers

Active Pharmaceutical Ingredient (API) Suppliers

Clobazam’s API sourcing is vital given its influence on quality, cost, and availability. Leading API manufacturers include:

Hangzhou Zhongmei Huadong Pharms (China): Major API producer, with extensive GMP-certified facilities.
Daiichi Sankyo (Japan): Known for high-quality APIs, often supplied for international markets.
Mingfeng Pharmaceutical (China): Supplies bulk API to multiple generics manufacturers.

Excipient and Packaging Suppliers

While less emphasized, excipients used in formulation, such as binders and fillers, are supplied by firms like:

BASF
DuPont
Ashland

Packaging providers ensure tamper-proof blister packs, bottles, and labeling comply with regulatory standards.

Distribution and Logistics

Wholesalers

UCB Pharma’s distribution network relies on licensed distributors, including:

McKesson
AmerisourceBergen
Cardinal Health

These companies facilitate rapid delivery to pharmacies, hospitals, and clinics, ensuring consistent supply.

Regulatory and Compliance

Distribution channels must adhere to strict regulations dictated by agencies such as the FDA and EMA. This includes maintaining cold chain logistics where necessary and ensuring traceability.

Strategic Partnerships and Market Penetration

UCB has formed strategic collaborations with regional distribution firms to expand access in emerging markets. For instance, partnerships in Latin America and Southeast Asia ensure local compliance and facilitate registration of Daybue in diverse regulatory landscapes.

Regulatory Considerations and Impact on Suppliers

The strict regulatory framework surrounding Schedule IV drugs like clobazam influences supplier selection and manufacturing practices. Suppliers must demonstrate GMP compliance, quality assurance, and transparent traceability. To mitigate supply chain risks, UCB and other stakeholders diversify sourcing and maintain safety stocks.

Challenges in the Supplier Landscape

Supply Disruptions: Political, economic, or pandemic-related disruptions in key manufacturing regions (notably China and India) may impact API availability.
Regulatory Hurdles: Different countries' approval processes can delay market entry or restrict supply continuity.
Patent and Competition Issues: While Daybue has patent protection, the presence of generics increases market competition, affecting supply dynamics.

Future Outlook

As the demand for Daybue grows, especially for the treatment of rare epileptic syndromes, supply chain resilience and strategic procurement will be paramount. Innovations in manufacturing, such as continuous synthesis of APIs, and increased diversification of suppliers can help stabilize supply and mitigate risks.

Key Takeaways

UCB Pharma remains the primary manufacturer and supplier of Daybue, utilizing both internal facilities and external CMOs.
Multiple generic manufacturers produce clobazam, with key API suppliers in China and Japan influencing global supply.
Robust distribution networks, including major pharmaceutical wholesalers, facilitate timely product delivery.
Supply chain risks include geopolitical issues, regulatory delays, and manufacturing disruptions, which require proactive mitigation strategies.
Strategic partnerships and diversification in sourcing are critical to ensuring sustained availability of Daybue.

FAQs

1. Who are the main API suppliers for Daybue (clobazam)?
Major API suppliers include Hangzhou Zhongmei Huadong Pharms (China), Daiichi Sankyo (Japan), and Mingfeng Pharmaceutical (China), providing high-quality APIs compliant with GMP standards.

2. Can generic manufacturers produce equivalent clobazam to Daybue?
Yes, several generics manufacturers produce clobazam. However, manufacturing practices and quality control standards are critical, especially for drugs used in neurological conditions.

3. How does UCB Pharma ensure supply chain resilience for Daybue?
UCB diversifies API sourcing, partners with multiple CMOs, maintains safety stock levels, and complies with regulatory standards to mitigate supply disruptions.

4. Are there regional differences in Daybue supply?
Yes, regulatory approval processes and local manufacturing capacities influence availability across regions, with UCB managing strategic partnerships for global reach.

5. What future trends could impact Daybue’s supply chain?
Emerging manufacturing technologies, geopolitical stability, and evolving regulatory environments will shape supply chain strategies, emphasizing diversification and agility.

References

[1] UCB Pharma. FDA Approval and Product Launch Details.
[2] Global API Market Reports. (2022).
[3] WHO Pharmacovigilance and Supply Chain Guidelines.
[4] Industry Analysis: Generic Clobazam Manufacturers.
[5] Regulatory Considerations for Schedule IV Drugs.

Suppliers and packagers for DAYBUE

DAYBUE

Suppliers for the Pharmaceutical Drug: Daybue