Bulk Pharmaceutical API Sources for SYNDROS

Bulk Pharmaceutical API Sources for SYNDROS

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		T2386_SIGMA
BOC Sciences		1972-08-3
Sigma-Aldrich		1651621_USP
Sigma-Aldrich		56296_SIAL
Sigma-Aldrich		94785_SIAL
Sigma-Aldrich		T4764_SIAL
LGC Standards		LGCAMP1088.00-01

Bulk Active Pharmaceutical Ingredient (API) Sources for Syndros

Last updated: July 27, 2025

Introduction

Syndros, marketed by Cannabis Science Inc. and approved by the U.S. Food and Drug Administration (FDA) in 2016, is a liquid oral formulation of dronabinol—synthetic tetrahydrocannabinol (THC). Dronabinol is used primarily for chemotherapy-induced nausea and AIDS-related anorexia. The pharmaceutical manufacturing and distribution of Syndros depend on reliable, high-quality sources of its active pharmaceutical ingredient (API), namely dronabinol. Understanding the landscape of API sourcing for Syndros involves examining licensed manufacturers, regulatory considerations, and global supply chains.

API Manufacturing and Regulatory Oversight

The production of synthetic THC APIs like dronabinol involves complex chemical synthesis processes governed by stringent regulatory standards, including Good Manufacturing Practice (GMP) compliance. Since Syndros is a Schedule III controlled substance in the United States, API manufacturers must adhere to DEA regulations concerning secure handling and distribution.

Major API producers for dronabinol typically operate under licenses granted by national regulatory agencies, ensuring quality, safety, and traceability. Notable among these are pharmaceutical-grade chemical manufacturers located in regions with robust chemical manufacturing infrastructure, such as North America, Western Europe, and Israel.

Leading API Suppliers for Dronabinol

1. PAR Pharmaceutical (now part of Endo Pharmaceuticals)

Historically, PAR Pharmaceutical was among the early producers of synthetic cannabinoids and APIs for medical use. Their manufacturing facilities in the U.S. enable compliance with FDA GMP standards, facilitating domestic distribution of APIs for drugs like Syndros.

2. Canadian and US-based Chemical Manufacturers

Canadian firms such as specialization companies like Avesthagen and Emerachem have demonstrated capabilities in synthesizing cannabinoids at GMP standards, often exporting APIs to the US and Europe. The proximity to North American markets provides logistical advantages for guaranteeing supply continuity.

3. Israel-based API Manufacturers

Israel's advanced pharmaceutical industry, led by companies such as Taro Pharmaceuticals and Teva Pharmaceuticals, has developed expertise in synthetic cannabinoids. These firms produce APIs under strict GMP conditions suitable for U.S. and global markets, leveraging Israel’s strong scientific infrastructure.

4. European API Suppliers

European pharmaceutical companies, including Sigma-Aldrich (now part of Merck KGaA) and other specialized API producers, manufacture synthetic cannabinoids potentially suitable for API supply chains, primarily for research or off-label applications, though their direct involvement in Syndros production remains limited.

5. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies engage third-party CMOs specializing in synthetic cannabinoids. These organizations often produce APIs under contract, providing scalability and flexibility to meet fluctuating demand for syndros-related APIs.

Quality and Regulatory Considerations in API Sourcing

The critical importance of API source quality for controlled substances like dronabinol cannot be overstated. Suppliers must:

• Maintain GMP compliance to ensure batch-to-batch consistency.

• Obtain necessary DEA licensing and approvals for Schedule III controlled substances.

• Submit rigorous documentation and batch records for regulatory audits.

• Verify raw material supply chains to avoid contamination or adulteration.

• Ensure traceability and secure transportation protocols compliant with controlled substance regulations.

Non-compliance or quality lapses can result in regulatory actions, recalls, and market access restrictions, underscoring the importance of sourcing from reputable, compliant manufacturers.

Supply Chain Challenges and Risks

• Regulatory Delays: Ongoing regulatory oversight can delay API production or shipments, especially across international borders where controlled substance regulations vary.

• Supply Disruptions: Geopolitical issues, manufacturing facility shutdowns, or raw material shortages pose risks to consistent API supply.

• Cost Fluctuations: Variability in raw material prices, manufacturing costs, and compliance expenses influence API pricing and availability.

• Legal and Compliance Risks: Changes in drug scheduling or regulatory frameworks may impact API manufacturing and supply continuity.

Global Market Dynamics

The global API market for cannabinoids is evolving rapidly, driven by increasing medicinal cannabis acceptance and synthetic cannabinoid research. While the synthetic production of dronabinol remains somewhat niche compared to plant-derived cannabinoids, market growth is fueling increased investments in compliant API manufacturing capacity worldwide.

The U.S. and European markets dominate demand, leading to heightened scrutiny and collaboration with key licensed producers. Emerging markets are exploring local synthesis capabilities but face regulatory and technological barriers.

Conclusion

The sourcing of APIs for Syndros hinges on a narrow pool of highly regulated, GMP-compliant manufacturers specializing in synthetic cannabinoids. U.S.-based manufacturers like PAR Pharmaceutical, Israeli companies such as Taro Pharmaceuticals, and select European API providers serve as primary sources. These suppliers must meet strict regulatory, quality, and security standards due to Syndros's controlled substance status. The evolving global landscape presents both opportunities and risks, emphasizing the importance of establishing reliable, compliant supply chains rooted in robust regulatory oversight.

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Key Takeaways

• The primary API source for Syndros—dronabinol—comes from licensed, GMP-compliant manufacturers with extensive regulatory approval processes.
• U.S. companies like PAR Pharmaceuticals and Israeli firms such as Taro are key players in API supply for synthetic THC.
• Regulatory compliance, secure handling, and strict quality standards are critical considerations for API sourcing in controlled substances.
• Supply chain risks include geopolitical factors, regulatory delays, and raw material shortages, necessitating diversified sourcing strategies.
• The expanding global demand for cannabinoids is prompting increased production capacity, but regulatory hurdles will remain a significant influence on API availability.

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FAQs

1. Are there multiple sources of API for Syndros globally?
Yes. Approved and licensed manufacturers in the U.S., Israel, and Europe supply GMP-compliant dronabinol APIs, though manufacturing is tightly regulated due to the controlled substance nature.

2. How does regulatory oversight impact API sourcing for Syndros?
Regulatory oversight requires strict licensing, GMP adherence, and detailed documentation, limiting the number of reliable API suppliers and increasing manufacturing costs.

3. What are the main risks associated with API supply for Syndros?
Risks include regulatory delays, geopolitical instability, raw material shortages, manufacturing disruptions, and legal changes affecting controlled substance production.

4. Can synthetic cannabinoid APIs be produced outside regulated environments?
While technically possible, production outside licensed GMP facilities poses significant legal, quality, and safety concerns, rendering such APIs unsuitable for pharmaceutical use.

5. How is the future of API supply for Syndros expected to evolve?
As medicinal cannabis and synthetic cannabinoids gain acceptance, more licensed manufacturers may enter the market, improving supply stability, though regulatory hurdles will remain paramount.

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References

[1] U.S. Food and Drug Administration. (2016). Syndros (dronabinol)—FDA approval details.
[2] DEA Diversion Control Division. (2022). Legal regulations for Schedule III substances.
[3] European Medicines Agency. (2021). Manufacturing standards for cannabinoid-based medicinal products.
[4] Israel Ministry of Health. (2020). Licensing and regulation of pharmaceutical cannabinoids.
[5] Global Industry Analysts. (2022). The cannabinoids market: Access and supply chains.

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Note: This article synthesizes publicly available data and industry insights up to 2023. Specific manufacturers' current licensing status and capacity should be verified through official regulatory channels before making procurement or business decisions.