OXTELLAR XR: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810	NDA	Supernus Pharmaceuticals, Inc.	17772-121-01	100 TABLET in 1 BOTTLE (17772-121-01)	2013-01-17
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810	NDA	Supernus Pharmaceuticals, Inc.	17772-121-07	7 TABLET in 1 BOTTLE (17772-121-07)	2013-01-17
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810	NDA	Supernus Pharmaceuticals, Inc.	17772-121-10	5 TABLET in 1 BLISTER PACK (17772-121-10)	2013-01-17
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810	NDA	Supernus Pharmaceuticals, Inc.	17772-122-01	100 TABLET in 1 BOTTLE (17772-122-01)	2013-01-17
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810	NDA	Supernus Pharmaceuticals, Inc.	17772-122-07	7 TABLET in 1 BOTTLE (17772-122-07)	2013-01-17
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

OXTELLAR XR, a specialized pharmaceutical formulation of oxycodone extended-release, is used primarily for managing moderate to severe pain where around-the-clock opioid therapy is appropriate. As a controlled-release formulation, OXTELLAR XR’s supply chain is highly regulated, involving multiple stakeholders from manufacturing to distribution. This article provides an in-depth analysis of key suppliers involved in the production, packaging, and distribution process of OXTELLAR XR, highlighting the critical components of its supply chain and factors influencing supplier selection.

Manufacturers of OXYCODONE Active Pharmaceutical Ingredient (API)

1. Leading producers of oxycodone API

OXTELLAR XR’s quality and efficacy hinge on a high-purity oxycodone API. Several pharmaceutical companies hold licenses to produce oxycodone API, including:

Purdue Pharma (United States): Historically, Purdue Pharma has been a significant supplier of oxycodone in the U.S., producing both APIs and the final formulations. Although Purdue faced legal challenges related to opioid distribution, its manufacturing operations historically contributed to the supply chain of oxycodone products [1].
Mallinckrodt Pharmaceuticals (Ireland/United States): A major global supplier of oxycodone API, Mallinckrodt produces in compliance with strict regulatory standards, including cGMP (current Good Manufacturing Practices). Their API is used in various oxycodone formulations, including controlled-release versions.
Indivior (United Kingdom): While primarily focused on addiction treatment medications, Indivior also holds manufacturing capacities for opioids used in specific formulations, including oxycodone APIs for prescription products.
Petronas Chemicals Group (Malaysia): Emerging as a supplier in the Asian market, Petronas has invested in API manufacturing capabilities, including opioids, contingent on regional demand and regulatory approvals.
Contract Manufacturing Organizations (CMOs): Many pharmaceutical companies outsource API production to CMOs specializing in high-potency APIs, ensuring supply chain flexibility and capacity.

2. Regulatory considerations

The production of oxycodone API is tightly controlled under international and national narcotics legislation, such as the Single Convention on Narcotic Drugs (1961) and respective local regulations. Suppliers must secure licenses from authorities like the Drug Enforcement Administration (DEA) in the U.S. or the European Medicines Agency (EMA) to produce, handle, and distribute oxycodone APIs.

Formulation and Final Product Manufacturing

3. Contract Manufacturers and Formulation Specialists

Many pharmaceutical firms, including Purdue Pharma and Teva Pharmaceuticals, partner with CMOs for final formulation, tableting, and quality control. These organizations:

Ensure the consistent release profile of OXTELLAR XR through advanced drug delivery technologies such as matrix systems or osmotic pump mechanisms.
Conduct stability and safety testing under Good Laboratory Practices (GLP).
Maintain batch reproducibility and compliance with regulatory authorities.

4. Proprietary Technologies

OXTELLAR XR employs proprietary extended-release technology, often licensed or developed in-house. The formulation process involves:

Polymer matrix systems that control drug release rates.
Quality assurance protocols such as in-process controls and validation studies.

Such proprietary processes often restrict manufacturing to select qualified suppliers, maintaining product integrity.

Packaging and Labeling Suppliers

5. Packaging Material Suppliers

Packaging for OXTELLAR XR demands high security and tamper-evident features due to its status as a Schedule II controlled substance:

Primary Packaging: Blister packs, bottles made from high-grade plastics, and foil seals sourced from vendors like WestRock, Berry Global, or Huhtamaki.
Secondary Packaging: Cartons and labels supplied by specialized packaging firms conforming to serialization mandates—tracking and traceability requirements under regulations such as DSCSA (Drug Supply Chain Security Act).
Security Features: Incorporation of holograms, QR codes, and tamper-evident seals supplied by security packaging firms to prevent diversion and counterfeiting.

Distribution and Logistics Providers

6. Wholesalers and Distributors

OXTELLAR XR prominently features within the supply chains of major pharmaceutical wholesalers such as:

McKesson Corporation
AmerisourceBergen
Cardinal Health

These entities distribute to hospitals, pharmacies, and clinics under strict regulatory oversight.

7. Cold Chain and Controlled Substance Logistics

Due to its schedule II classification, transportation involves specialized logistic services:

Licensed carriers with narcotics-specific handling capabilities.
Temperature-controlled transport where necessary.
Real-time tracking systems to ensure regulatory compliance and prevent diversion.

Regulatory and Compliance Partners

8. Regulatory Consultants and Certification Bodies

Suppliers and manufacturers coordinate with regulatory consultants for:

GMP compliance assessments
Inspection readiness
Certifications such as ISO 9001/13485

These partnerships ensure supply security and adherence to evolving international standards.

Key Factors Influencing Supplier Selection

Regulatory compliance: Strict licensing and adherence to narcotics handling regulations.
Quality assurance: Proven track record of consistent high-quality production.
Capacity and scalability: Ability to meet global demand and exceptional quality control.
Technology licensing: Proprietary formulation technologies requiring specialized suppliers.
Security measures: Packaging and logistical solutions to prevent diversion.

Conclusion

The supply chain for OXTELLAR XR is a complex ecosystem involving multiple tiers of suppliers, each playing a critical role from API synthesis to final distribution. The majority of active ingredients originate from licensed API manufacturers, with formulation, packaging, and logistics segmented among specialized CMOs, packaging firms, and distribution companies. Regulatory compliance and security are paramount, necessitating partnerships with suppliers that demonstrate rigorous standards and technological expertise. Companies aiming to optimize or enter the OXTELLAR XR supply chain must prioritize supplier reputation, compliance, technological capabilities, and logistic security to ensure uninterrupted, lawful access to this controlled medication.

Key Takeaways

API sourcing is predominantly managed by established and licensed manufacturers, such as Mallinckrodt and Purdue Pharma, ensuring high-quality oxycodone supplies.
Formulation and packaging involve proprietary technologies and security features to prevent diversion, handled by specialized pharmaceutical and packaging partners.
Distribution networks rely on major US and global wholesalers adhering to strict narcotics logistics and regulatory standards.
Regulatory compliance and security are critical at every supply chain stage, influencing supplier selection and operational protocols.
Supply chain resilience depends on diversified supplier bases, robust quality controls, and secure logistics partnerships, especially given the drug’s potential for abuse and diversion.

FAQs

1. Who are the primary manufacturers of oxycodone API for OXTELLAR XR?
Major manufacturers include Mallinckrodt Pharmaceuticals and historically Purdue Pharma, both licensed to produce oxycodone API under strict regulatory oversight [1].

2. How is the proprietary release technology of OXTELLAR XR licensed or sourced?
The technology is often developed in-house or via licensing agreements with specialized firms, enabling controlled and sustained drug release profiles.

3. What role do packaging suppliers play in maintaining the security of OXTELLAR XR?
They provide tamper-evident, security-enhanced packaging solutions, including serialization and hologram features, to prevent diversion and counterfeiting.

4. How do distribution partners ensure compliance with narcotics regulations during transportation?
They utilize licensed carriers with specialized handling capabilities, real-time tracking, and temperature control to meet DEA or equivalent regulatory standards.

5. What factors influence the selection of suppliers in the OXTELLAR XR supply chain?
Regulatory adherence, product quality, manufacturing capacity, proprietary technology access, and security measures are critical considerations.

References

[1] U.S. Food and Drug Administration. (2022). "OxyContin (oxycodone) Extended-Release Tablets."
[2] European Medicines Agency. (2021). "Guidelines for opioid manufacturing."
[3] Official Gazette of International Narcotics Control Board (INCB). (2022). "Narcotics manufacturing licenses."

Suppliers and packagers for OXTELLAR XR

OXTELLAR XR

Suppliers for the Pharmaceutical Drug: OXTELLAR XR