ONFI: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lundbeck Pharms Llc	ONFI	clobazam	SUSPENSION;ORAL	203993	NDA	Lundbeck Pharmaceuticals LLC	67386-313-21	1 BOTTLE in 1 CARTON (67386-313-21) / 120 mL in 1 BOTTLE	2012-12-14
Lundbeck Pharms Llc	ONFI	clobazam	TABLET;ORAL	202067	NDA	Lundbeck Pharmaceuticals LLC	67386-314-01	1 BOTTLE in 1 CARTON (67386-314-01) / 100 TABLET in 1 BOTTLE	2013-12-10
Lundbeck Pharms Llc	ONFI	clobazam	TABLET;ORAL	202067	NDA	Lundbeck Pharmaceuticals LLC	67386-315-01	1 BOTTLE in 1 CARTON (67386-315-01) / 100 TABLET in 1 BOTTLE	2013-12-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

ONFI is a prescription medication primarily composed of clobazam, a benzodiazepine used to treat seizures associated with Lennox-Gastaut syndrome and other epileptic conditions. As a critical medication requiring high quality and consistent supply, understanding its supplier landscape is essential for healthcare providers, distributors, and regulatory authorities. The global supply chain for ONFI involves a network of licensed pharmaceutical manufacturers, raw material suppliers, and distribution channels, each subject to stringent regulatory oversight to ensure safety and efficacy.

Manufacturers of ONFI (Clobazam)

1. Lundbeck (H. Lundbeck A/S)

Lundbeck, a Danish pharmaceutical leader, is the original patent-holder and manufacturer of ONFI. The company developed ONFI to address treatment-resistant seizures and holds the broad regulatory approvals across many jurisdictions, including the FDA for the United States. Lundbeck maintains a controlled manufacturing environment, ensuring product consistency, quality, and compliance with Good Manufacturing Practices (GMP). Their facilities are inspected regularly by regulatory authorities, ensuring ongoing compliance.

2. Generics Manufacturers

As patents expired or approaches expiration, multiple generic manufacturers have entered the market to supply clobazam as labeled ONFI or under other branded names. These manufacturers include:

Torrent Pharmaceuticals (India): Licensed to produce generic clobazam; their manufacturing centers adhere to US FDA and EMA standards, enabling export to regulated markets.
Zhejiang Hualv Pharmaceutical (China): Offers generic clobazam, meeting international quality standards, though regulatory approvals vary by region.
Dr. Reddy’s Laboratories (India): Has developed and approved generic formulations of clobazam, supplying global markets with cost-effective alternatives.
Mundipharma: Although primarily focused on pain management, Mundipharma markets generic benzodiazepines, including clobazam variants in licensing agreements.

It is essential to verify each manufacturer's licensing status with regulatory authorities like the US FDA or EMA. Not all generics possess official approval for all markets, which influences their utilization.

Sources of Raw Materials

The key raw material for ONFI's active pharmaceutical ingredient (API) is clobazam itself. The suppliers of API are located predominantly in India, China, and Europe, with major players including:

Cornell Chem Pharma (India): Supplies high-purity API, compliant with WHO-GMP standards.
Wuxi AppTec (China): Offers API manufacturing with international certifications.
Evonik Industries (Germany): Provides pharmaceutical excipients and, in some cases, active chemicals.

The quality and source of raw materials directly impact the final product's safety profile. Manufacturers rely on suppliers with proven compliance histories and robust quality assurance protocols.

Distribution and Supply Chain

The supply chain for ONFI extends from licensed manufacturers to regional distributors, pharmacy chains, hospitals, and specialty pharmacies. Distributors such as McKernan and Cardinal Health facilitate the distribution within the US, ensuring product integrity during transit and storage. These distributors maintain temperature controls and security measures aligned with regulatory expectations for controlled substances like benzodiazepines.

Supply continuity is occasionally impacted by manufacturing delays, regulatory inspections, or raw material shortages, particularly given the complexities of importing APIs and finished formulations across borders.

Regulatory Considerations and Due Diligence

Due to the controlled nature of benzodiazepines, suppliers must hold requisite licenses for manufacturing, importing, and distributing controlled substances. Regulatory oversight bodies include:

US Food and Drug Administration (FDA)
European Medicines Agency (EMA)
World Health Organization (WHO)
Drug enforcement agencies in various countries

Manufacturers and suppliers must adhere to strict compliance standards, including serialization, track-and-trace systems, and regular audits to prevent diversion or misuse.

Emerging Trends and Market Dynamics

The global pharmaceutical market's shift toward biosimilars and generics influences the ONFI supply landscape. Patent expirations have increased the number of manufacturers, which benefits supply availability and price competitiveness. However, the complexity of benzodiazepine manufacturing means not all players can meet regulatory standards, limiting some suppliers' market access.

Additionally, geopolitical factors, trade policies, and supply chain disruptions—such as those observed during the COVID-19 pandemic—affect the stability and security of ONFI supply chains. Strategic stockpiling and diversification of suppliers are increasingly adopted to mitigate risks.

Quality Assurance and Certification Standards

Suppliers are expected to conform to a range of quality standards:

Good Manufacturing Practices (GMP)
Good Agricultural and Collection Practices (GACP)
ISO Certification
Regulatory approvals and certificates for APIs and finished products

Pharmaceutical companies conducting procurement should undertake rigorous supplier qualification processes, including audits, documentation reviews, and compliance assessments to ensure the integrity of ONFI products.

Key Challenges in Supply Chain

Regulatory compliance: Ensuring all suppliers hold proper licenses and certifications
Raw material sourcing: Securing high-quality APIs amidst geopolitical tensions
Manufacturing capacity: Scaling production to meet global demand
Distribution logistics: Maintaining cold chain and secure transportation
Counterfeit prevention: Implementing serialization and anti-diversion measures

Future Outlook

The global demand for ONFI is expected to grow, driven by increased diagnosis of epilepsy syndromes and expanded indications. Addressing supply chain vulnerabilities through supplier diversification, strategic partnerships, and technological innovations (e.g., blockchain for traceability) will be crucial for maintaining consistent supply levels.

Key Takeaways

Original manufacturer Lundbeck dominates the ONFI market, with multiple licensed generics from India, China, and Europe providing additional supply options.
High-quality raw materials and API suppliers are concentrated in India and China but must meet strict international pharmaceutical standards.
Regulatory compliance remains a critical factor in supplier qualification, affecting availability and market access.
Supply chain disruptions are mitigated by diversification strategies, robust logistics, and adherence to strict quality standards.
The evolving landscape of generics and biosimilars offers opportunities to enhance supply security and reduce costs.

FAQs

1. Who are the primary manufacturers of ONFI (clobazam)?
Lundbeck is the original manufacturer, with licensed generics provided by companies such as Torrent Pharmaceuticals, Dr. Reddy’s Laboratories, and others conforming to regulatory standards.

2. How is the supply chain for ONFI regulated?
Suppliers must adhere to GMP, GACP, and possess licenses from regulatory authorities like the FDA and EMA. Regular inspections and certifications ensure compliance and supply integrity.

3. Are there alternative sources for ONFI if the primary supplier faces shortages?
Yes; multiple licensed generics and API suppliers exist. Diversifying procurement channels and maintaining buffer stocks mitigate shortages.

4. What are common quality concerns associated with ONFI’s raw materials?
Potential issues include contamination, inconsistent API purity, or sourcing from unlicensed suppliers. Rigorous qualification and quality audits prevent these risks.

5. How do geopolitical factors influence ONFI's supply chain?
Trade restrictions, tariffs, and export controls in regions like China and India can impact raw material availability and manufacturing capacity, emphasizing the need for diversified sourcing strategies.

References

[1] Lundbeck. (2022). ONFI (clobazam) product information.
[2] FDA Drug Approvals and Labeling Records. (2021). Clobazam (ONFI) approval details.
[3] European Medicines Agency. (2022). Marketing authorization for clobazam.
[4] Pharmaceutical Industry Reports. (2022). Global clobazam API and finished product market analysis.
[5] World Health Organization. (2020). Guidelines on pharmaceutical raw material sourcing.

Suppliers and packagers for ONFI

ONFI

Suppliers for the Pharmaceutical Drug: ONFI (Clobazam)