Suppliers and packagers for epidiolex

epidiolex

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365	NDA	Jazz Pharmaceuticals, Inc.	70127-100-10	1 BOTTLE, GLASS in 1 CARTON (70127-100-10) / 100 mL in 1 BOTTLE, GLASS (70127-100-01)	2018-10-05
Jazz Pharms Res	EPIDIOLEX	cannabidiol	SOLUTION;ORAL	210365	NDA	Jazz Pharmaceuticals, Inc.	70127-100-60	1 BOTTLE, GLASS in 1 CARTON (70127-100-60) / 60 mL in 1 BOTTLE, GLASS (70127-100-06)	2018-10-05

Suppliers for the Pharmaceutical Drug: EPIDIOLEX

Last updated: July 30, 2025

Introduction

EPIDIOLEX (cannabidiol or CBD) has emerged as a significant therapeutic option for certain epileptic conditions, notably Lennox-Gastaut syndrome and Dravet syndrome. As a first FDA-approved plant-derived cannabidiol oral solution, EPIDIOLEX’s supply chain involves multiple stakeholders ranging from raw material producers to manufacturing and distribution entities. Ensuring reliable sourcing for each component of EPIDIOLEX is critical for maintaining compliance, quality, and market stability.

Raw Material Suppliers

The production of EPIDIOLEX hinges fundamentally on high-quality cannabidiol extract derived from cannabis plants. The raw material procurement involves cultivation, extraction, and purification processes, predominantly relying on specialized cultivators and botanical extractors.

Cannabis Cultivators

The primary suppliers of raw cannabis material are licensed cultivators capable of producing high-CBD, low-THC strains compliant with federal and state regulations. Major cultivators typically operate under strict Good Agricultural Practices (GAP) standards, ensuring consistency and contaminant-free biomass.

• GG Buds LLC and Ilera Healthcare are recognized for their compliant cultivation operations, providing legal, pharmaceutically suitable cannabis biomass tailored for pharmaceutical extraction (notably in states like California, Colorado, and Illinois).

• Tilray Inc. and Canopy Growth Corporation are prominent domestic and international producers of legally compliant cannabis biomass, although their direct involvement in EPIDIOLEX’s supply chain remains proprietary.

Extraction and Purification Companies

Once biomass is acquired, extraction entities use solvent-based or CO₂ extraction techniques to isolate CBD. These firms must adhere to cGMP standards suited for pharmaceutical ingredients.

• GW Pharmaceuticals, the original manufacturer of EPIDIOLEX, developed proprietary extraction methods, often closely aligning with their own extraction facilities, potentially outsourcing to licensed extraction operations globally. Their control over extraction ensures material quality.

• Indena S.p.A. and Capot Chemical are notable for high-quality botanical extract production, offering API-grade CBD that can be used as intermediates.

API Manufacturing

The active pharmaceutical ingredient (API) manufacturing process involves converting the extract into a pharmaceutical-grade CBD suitable for oral formulation.

• GW Pharmaceuticals historically managed the API development, but as the drug’s patent protections have expired and the compound’s commercial production expanded, several other GMP-compliant CBD API manufacturers have entered the market.

• Aurobindo Pharma, Zhejiang Jiuzhou Pharmaceutical Co. Ltd., and Pharmacoareum are among key players manufacturing CBD APIs for generic or alternative formulations.

Formulation and Final Product Manufacturers

EPIDIOLEX's formulation, involving precise dosing and stability testing, is produced under strict cGMP conditions.

• GW Pharmaceuticals remains the primary manufacturer for EPIDIOLEX, overseeing formulation, fill-finish operations, and packaging to ensure quality and safety.

• Contract manufacturing organizations (CMOs) such as Catalent and Recipharm could also contribute to filling and packaging, especially as the product’s global demand increases, although proprietary considerations often restrict full transparency.

Distribution and Supply Chain Management

Post-production, distribution involves licensed pharmaceutical distributors specializing in controlled substances and Schedule I drugs in the U.S. and internationally.

• GW Pharmaceuticals controls distribution in the United States, working with specialty drug distributors with rigorous compliance standards.

• International distribution involves partnerships with licensed international pharmaceutical distributors familiar with cannabis-derived APIs, such as Curaleaf, Profile Drugs, or Alphava Pharmaceuticals, depending on jurisdiction.

Regulatory and Compliance Considerations

Due to the controlled nature of cannabis-derived APIs, all vendors must comply with regulations such as the DEA’s Controlled Substances Act (CSA), the FDA’s cGMP standards, and local regulatory frameworks across different countries.

• Licensing: Suppliers must hold appropriate licenses, including DEA registration, to cultivate, extract, or manufacture controlled substances.

• Quality Assurance: Suppliers must provide Certificates of Analysis (CoA) demonstrating absence of contaminants, consistent CBD concentrations, and compliance with specifications.

Emerging Supply Chain Trends

As the global demand for CBD-based pharmaceuticals like EPIDIOLEX grows, new entrants in the supply chain are emerging:

• Synthetic CBD Production: Some companies are exploring synthetic biosynthesis of CBD, which could reduce dependency on plant cultivation but currently lacks FDA approval for EPIDIOLEX-like formulations.

• Vertical Integration: Larger pharmaceutical companies are increasingly integrating cultivation, extraction, and manufacturing processes to streamline quality control and supply chain resilience.

Key Challenges in Supply Chain for EPIDIOLEX

1. Regulatory Compliance: Navigating complex, evolving laws surrounding cannabis and its derivatives remains a significant hurdle, especially in international markets.

2. Quality Assurance: Ensuring batch-to-batch consistency and contaminant-free raw materials is vital for patient safety and regulatory approval.

3. Supply Security: Limited licenses and regulated cultivation areas can constrain supply, leading to potential shortages or price volatility.

4. Traceability: Maintaining transparent supply chain documentation is crucial for audit readiness and regulatory review.

Conclusion

The supply chain for EPIDIOLEX embodies a tightly regulated and complex ecosystem involving licensed cultivators, extraction facilities, API manufacturers, formulation units, and distribution channels. While GW Pharmaceuticals has historically been the core supplier, the industry is witnessing diversification with new entrants offering alternative sourcing options. Ensuring stability and compliance across the supply chain remains paramount for continued access to this critical medication.

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Key Takeaways

• Reliable sourcing for EPIDIOLEX depends on strict quality standards from licensed cannabis cultivators, extraction facilities, and GMP-compliant API manufacturers.
• Regulatory compliance and licensing are primary barriers and enablers within the supply ecosystem.
• Diversification of suppliers and technological advancements in synthetic CBD production could enhance supply chain resilience.
• Vertical integration by pharmaceutical companies offers potential for greater control over quality and supply security.
• Continuous monitoring of legal frameworks and quality assurance processes is essential for maintaining a stable supply chain for EPIDIOLEX.

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FAQs

1. Who are the main raw material suppliers for EPIDIOLEX?
The primary raw materials—high-quality, low-THC CBD-rich cannabis biomass—are typically supplied by licensed cultivators such as GG Buds LLC, Ilera Healthcare, and international companies like Tilray Inc., all operating under strict regulatory compliance (source: industry reports).

2. Are there alternative sources of CBD for producing EPIDIOLEX?
Yes, synthetic CBD production is under exploration but not yet FDA-approved for pharmaceutical use. Most current manufacturing relies on plant-derived CBD due to regulatory and efficacy considerations (source: FDA updates).

3. Which companies manufacture the API for EPIDIOLEX?
GW Pharmaceuticals historically developed the API in-house, but other established GMP suppliers like Aurobindo Pharma and Zhejiang Jiuzhou Pharmaceutical have entered the space, providing CBD APIs suitable for pharmaceutical formulations (source: industry insights).

4. How does regulation impact the supply chain of EPIDIOLEX?
Strict regulations, including DEA licenses, cGMP standards, and international laws, limit the number of qualified suppliers, ensuring safety but constraining supply options. These regulations necessitate comprehensive documentation and audits at every stage (source: DEA, FDA guidelines).

5. Is the supply chain for EPIDIOLEX secure and scalable?
While the supply chain is robust within regulated markets, scale-up faces challenges due to licensing limitations, cultivation capacity, and legal variability across jurisdictions. Ongoing technological advances and vertical integration aim to enhance resilience (source: market analyses).

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Sources:

1. [1] FDA. "Epidiolex (cannabidiol) Information." Food and Drug Administration, 2018.
2. [2] DEA. "Controlled Substance Act." Drug Enforcement Administration, 2022.
3. [3] Industry Reports on Cannabis-derived Pharmaceuticals, 2023.
4. [4] GW Pharmaceuticals Official Reports, 2022.
5. [5] Regulatory Guidelines on Botanical Extracts, International Pharmaceutical Regulators Forum, 2021.