Suppliers and packagers for sympazan

sympazan

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833	NDA	Aquestive Therapeutics	10094-205-60	60 POUCH in 1 PACKAGE (10094-205-60) / 1 FILM in 1 POUCH (10094-205-01)	2018-11-01
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833	NDA	Aquestive Therapeutics	10094-210-60	60 POUCH in 1 PACKAGE (10094-210-60) / 1 FILM in 1 POUCH (10094-210-01)	2018-11-01
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833	NDA	Aquestive Therapeutics	10094-220-60	60 POUCH in 1 PACKAGE (10094-220-60) / 1 FILM in 1 POUCH (10094-220-01)	2018-11-01

Suppliers for the Pharmaceutical Drug: Sympazan

Last updated: July 27, 2025

Introduction

Sympazan (clobazam) is a prescription medication primarily prescribed for managing seizures associated with Lennox-Gastaut syndrome (LGS), a severe form of epilepsy. As an important therapeutic agent, the supply chain of Sympazan hinges on a network of manufacturers, patent holders, and authorized distributors. Ensuring a reliable supply is crucial, given the medication's role in treating a vulnerable patient population. This article explores the key suppliers, manufacturing landscape, regulatory considerations, and market dynamics surrounding Sympazan.

Overview of Sympazan and its Supply Chain

Sympazan is the branded formulation of clobazam, developed and marketed by Jazz Pharmaceuticals. The drug is an orally administered benzodiazepine used adjunctively in complex seizure management. Its active pharmaceutical ingredient (API), clobazam, is a well-established compound with multiple manufacturers globally. The supply chain involves several bypassing stages—from API production to formulation, packaging, and distribution—each contributing to the overall availability.

Manufacturers of Clobazam API

Clobazam's API is produced by several generic and brand-name pharmaceutical manufacturers worldwide. Primary suppliers include:

1. Jazz Pharmaceuticals

Jazz Pharmaceuticals developed and markets Sympazan in the United States under the brand name. The company is responsible for the raw material sourcing, formulation, and distribution domestically, with authorized manufacturing partners ensuring ongoing supply.

2. Chinese and Indian API Manufacturers

China and India are significant global hubs for pharmaceutical raw materials, including clobazam API. Notable API manufacturers in these regions include:

• Hainan Pharmaceutical Co. (China): Known for producing high-quality APIs, including benzodiazepines like clobazam. Their APIs are exported worldwide, including to North American and European markets.

• Hetero Labs (India): A major generic pharmaceutical company, Hetero supplies APIs for multiple benzodiazepine compounds, including clobazam, with a focus on cost-effective production.

• Cadila Healthcare (India): Engaged in producing APIs that meet international standards for quality and safety, Cadila supplies these to generics manufacturers globally.

3. European Manufacturers

European API suppliers such as:

• Europea Pharma (Germany): Known for rigorous manufacturing standards conforming to Good Manufacturing Practices (GMP).
• Siegfried AG (Switzerland): Offers high-quality APIs for niche pharmaceuticals, including benzodiazepines.

4. Contract Manufacturing and Private Label Suppliers

Many generic drug manufacturers source API from third-party suppliers, emphasizing the importance of robust supply agreements and quality validation protocols to ensure consistent potency and purity.

Formulation and Packaging

Sympazan’s formulation involves a proprietary chewable tablet, which requires dedicated manufacturing lines. Jazz Pharmaceuticals maintains in-house facilities and collaborates with Contract Manufacturing Organizations (CMOs) to produce the final product. These CMOs are responsible for quality control, stability testing, and packaging compliance with regulatory standards.

Regulatory and Certification Dynamics

The global supply of Sympazan depends on compliance with regulatory bodies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and corresponding national agencies in Asia. API manufacturers must hold GMP certification, and their facilities are subject to audits to verify quality standards.

Due to the sensitive nature of benzodiazepine APIs, export licenses, and controlled substance registrations are crucial. Supply disruptions often stem from regulatory delays, manufacturing outages, or geopolitical factors impacting API exports, particularly from China and India.

Market and Supply Chain Challenges

• Regulatory hurdles: Stringent regulations entail frequent audits, potentially affecting API exports.
• Environmental and geopolitical factors: Trade restrictions and import-export bans can disrupt supply chains.
• Supply-demand dynamics: Increasing prevalence of Lennox-Gastaut syndrome amplifies demand, stressing supply capacity.
• Quality assurance: Counterfeit or substandard APIs pose risks to patient safety and require vigilant quality verification.

Emerging Trends and Future Outlook

• Vertical integration: Jazz Pharmaceuticals and other stakeholders may vertically integrate supply chains to mitigate risks.
• Diversification of API sources: Relying on multiple API suppliers reduces dependency on specific regions or manufacturers.
• Technological advancements: Improved manufacturing processes and advances in API synthesis enhance reliability and regulatory compliance.

Conclusion

The supply of Sympazan depends on a complex interplay of global API manufacturers, formulation specialists, and regulators. While Jazz Pharmaceuticals retains control over the branded product in key markets, the underlying API—clobazam—is produced by various manufacturers primarily in China, India, and Europe. Maintaining supply chain resilience requires ongoing management of regulatory compliance, supplier diversification, and quality assurance protocols.

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Key Takeaways

• Sympazan's active ingredient, clobazam, is produced by multiple global suppliers, with key manufacturing hubs in China, India, and Europe.
• Jazz Pharmaceuticals oversees domestic formulation and distribution, leveraging partnerships with CMOs for manufacturing.
• Regulatory compliance and GMP certifications are critical for ensuring API quality and legal exportability.
• Supply chain risks include geopolitical tensions, regulatory delays, and environmental disruptions.
• Diversification of API sources and technological advancements are essential strategies to ensure continuous supply.

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FAQs

1. Who are the main API suppliers for Sympazan?
The primary API suppliers include Chinese and Indian manufacturers such as Hainan Pharmaceutical, Hetero Labs, and Cadila Healthcare, alongside European producers like Europea Pharma and Siegfried AG.

2. Does Jazz Pharmaceuticals manufacture the API for Sympazan?
No. Jazz Pharmaceuticals formulates and markets Sympazan but relies on third-party API manufacturers for the active pharmaceutical ingredient.

3. How does regulatory compliance affect Sympazan's supply?
Strict adherence to GMP and regulatory approvals are vital. Non-compliance can lead to manufacturing halts, export bans, or recalls, disrupting supply chains.

4. Are there risks associated with relying on Chinese API manufacturers?
Yes. Geopolitical tensions, trade restrictions, or quality control issues can impact API availability from China, emphasizing the need for diversified sourcing.

5. What trends could impact future Sympazan supply?
Technological innovations, vertical integration by pharmaceutical companies, and efforts to diversify API sources will enhance supply resilience amid growing demand.

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Sources:

1. [1] Jazz Pharmaceuticals official website. Sympazan product information.
2. [2] U.S. FDA. Inactive Ingredient Database.
3. [3] Indian Pharmaceutical Industry Data. PharmaBiz.
4. [4] European Medicines Agency. Good Manufacturing Practice guidelines.
5. [5] Global API manufacturing reports. IQVIA Publications.