Suppliers and packagers for syndros

syndros

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Benuvia Operations	SYNDROS	dronabinol	SOLUTION;ORAL	205525	NDA	Benuvia Operations, LLC	78613-201-30	1 BOTTLE, GLASS in 1 CARTON (78613-201-30) / 30 mL in 1 BOTTLE, GLASS	2017-07-01

Suppliers for the Pharmaceutical Drug: Syndros

Last updated: July 29, 2025

Introduction

Syndros (dronabinol oral solution) is a prescription medication primarily used to treat nausea and vomiting associated with chemotherapy and to stimulate appetite in patients with wasting syndromes such as AIDS. As a synthetic THC (tetrahydrocannabinol) formulation, Syndros holds a unique place within the controlled substance landscape. Its manufacturing, distribution, and supplier network are tightly regulated under the U.S. Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA). This article offers a comprehensive overview of the key suppliers involved in Syndros’s production and distribution, contextualizing their roles within the broader pharmaceutical supply chain.

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Manufacturers of Syndros

1. Insys Therapeutics (now a subsidiary of Corium International)

Historical Context:
Insys Therapeutics originally developed Syndros and held exclusive manufacturing rights before emerging regulatory and legal challenges, including investigations into its marketing practices. Its role was pivotal in bringing Syndros to market, contributing to supply chain stability during its operational period.

Manufacturing Status:
In 2018, Insys faced significant legal issues, leading to its bankruptcy and sale of assets. Subsequently, manufacturing rights for Syndros were transferred to Corium International. The change in ownership underscores the importance of understanding current licensing and operational capacities of prevailing manufacturers.

2. Corium International

Current Manufacturer:
Following the insolvency of Insys, Corium International acquired the rights to produce Syndros. This transition aimed to continue consistent supply, leveraging Corium’s expertise in controlled substance manufacturing.

Manufacturing Capabilities:
Corium specializes in controlled substance manufacturing, with facilities compliant with cGMP (current Good Manufacturing Practices). Their processes ensure compliance with DEA regulations governing Schedule II substances.

3. Contract Manufacturing Organizations (CMOs)

Role in Supply Chain:
In addition to primary manufacturers, several CMOs may be engaged to scale production or ensure supply chain resilience. These third-party manufacturers operate under strict regulatory oversight, adhering to FDA and DEA standards.

Examples:
While specific contracts are often proprietary, the pharmaceutical industry routinely utilizes CMOs specializing in controlled substances. Some prominent companies in this domain include Catalent, Patheon (a part of Thermo Fisher), and ALP Pharmaceuticals, all of which maintain facilities capable of handling Schedule II compounds.

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Supply Chain and Distribution Channels

1. Distributors and Wholesalers

Regulatory Compliance:
Distribution of Syndros involves licensed DEA registrants who operate within a tightly regulated framework. These entities include large national wholesalers such as McKesson, Cardinal Health, and AmerisourceBergen, which are authorized to distribute Schedule II pharmaceuticals.

Process Flow:

• Production at manufacturing facilities
• Packaging and labeling under strict quality control
• Distribution to authorized pharmacies, hospitals, and specialty clinics via licensed distributors

2. Hospitals and Specialty Pharmacies

Distribution Points:
Once distributed via wholesalers, Syndros is supplied directly to hospitals, specialty clinics, and authorized pharmacies equipped to dispense controlled substances.

Access Control:
Due to its Schedule II status, dispensing is tightly controlled, requiring proper prescriptions and inventory tracking across the supply chain.

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Regulatory Oversight and Supplier Constraints

1. DEA Regulations

Syndros production and distribution are governed by the Controlled Substances Act (CSA). Manufacturers and distributors require specific DEA registrations, and all transactions are documented meticulously to prevent diversion.

2. Manufacturing Licensing

Manufacturers must hold valid FDA approvals and DEA registrations that authorize the production of Schedule II substances. Changes in ownership or manufacturing sites mandate notifications and approval from regulatory bodies.

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Emerging Trends and Future Outlook

1. Diversification of Suppliers

Pending legal and regulatory adjustments, there is potential for new manufacturers to enter the Syndros supply chain, improving resilience and pricing stability. However, strict regulatory barriers limit entry to only highly compliant entities.

2. Supply Chain Resilience

Recent disruptions, notably during the COVID-19 pandemic, exposed vulnerabilities in pharmaceutical supply chains. For controlled substances like Syndros, maintaining a diversified supplier pool and establishing contingency manufacturing agreements are critical.

3. Innovating Production Methods

Advances in synthetic chemistry and biotechnological manufacturing might enable alternative synthesis pathways, potentially reducing reliance on few suppliers. Nonetheless, regulatory hurdles remain substantial owing to controlled substance classifications.

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Key Takeaways

• Syndros’s primary manufacturer transitioned from Insys Therapeutics to Corium International following legal and financial challenges.
• Manufacturing, distribution, and handling of Syndros are strictly regulated under DEA Schedule II restrictions, involving licensed entities and rigorous oversight.
• Major pharmaceutical wholesalers such as McKesson, Cardinal Health, and AmerisourceBergen serve as principal distribution channels.
• The high barriers to entry, due to regulatory requirements, limit the number of suppliers and foster supply chain stability but can also pose risks of supply disruptions.
• Future supply chain developments hinge on regulatory changes, technological advances, and strategic planning by manufacturers and distributors.

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FAQs

Q1. Who are the current primary suppliers of Syndros?
A1. The main manufacturing rights are held by Corium International following the acquisition of assets from Insys Therapeutics. Distribution is primarily managed by licensed pharmaceutical wholesalers like McKesson, Cardinal Health, and AmerisourceBergen.

Q2. What regulatory challenges affect Syndros suppliers?
A2. Suppliers must comply with DEA Schedule II regulations, requiring special licenses, meticulous record-keeping, and secure storage. Any manufacturing or ownership changes require DEA and FDA approval.

Q3. Are there alternative suppliers or generic versions of Syndros?
A3. Currently, Syndros is a proprietary formulation. However, the development of generic equivalents depends on regulatory approval, which involves demonstrating bioequivalence and rigorous control over Schedule II substances.

Q4. How has the legal history of Insys Therapeutics impacted Syndros supply?
A4. Legal challenges led to Insys’s bankruptcy, transferring manufacturing rights to Corium International. This transition aimed to stabilize supply but introduced uncertainties about long-term manufacturing continuity.

Q5. What future trends could influence Syndros’s supplier landscape?
A5. Potential new entrants could emerge if regulatory frameworks evolve or patents expire. Advances in synthetic manufacturing might also lower barriers, but strict controls will likely remain to prevent diversion.

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References

1. U.S. Drug Enforcement Administration. (2022). Controlled Substances Schedules.
2. FDA. (2020). Drug Approval & Risk Management.
3. Insys Therapeutics. (2018). Company Press Releases.
4. Corium International. (2021). Corporate Reports.
5. Pharma Manufacturing. (2021). Controlled Substance Supply Chain Analysis.