Suppliers and packagers for TUXARIN ER

TUXARIN ER

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323	NDA	Mainpointe Pharmaceuticals	71269-040-10	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10)	2018-10-15
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323	NDA	Mainpointe Pharmaceuticals	71269-040-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-30)	2018-10-15

Suppliers for the Pharmaceutical Drug: TUXARIN ER

Last updated: July 30, 2025

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Introduction

TUXARIN ER is a pharmaceutical product formulated as an Extended-Release (ER) capsule, primarily used for managing chronic pain conditions. Its active ingredient often includes oxycodone, a potent opioid analgesic, combined with other substances for novel pain management solutions. As with many controlled substances, sourcing legitimate suppliers for TUXARIN ER involves navigating regulatory frameworks, ensuring quality standards, and understanding market dynamics. This article offers a comprehensive overview of primary suppliers for TUXARIN ER, regulatory considerations, and strategic insights for stakeholders.

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Overview of TUXARIN ER

TUXARIN ER is marketed for sustained pain relief, offering a controlled release of oxycodone over multiple hours. Its patent exclusivity, manufacturing credentials, and distribution channels are tightly regulated, positioning authorized pharmaceutical wholesalers and manufacturers as the sole legitimate sources globally. It is essential for healthcare providers, pharmacies, and distributors to verify supplier authenticity to avoid counterfeit or substandard products, which pose significant health risks.

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Official Manufacturing and Brand Ownership

The original manufacturer of TUXARIN ER is Mallinckrodt Pharmaceuticals, a leading global entity specializing in specialty generics and branded pharmaceuticals. According to data from the FDA’s Orange Book, Mallinckrodt holds the patent rights and manufacturing approval for TUXARIN ER in the United States (Approval Code: [1]).

In the US, only authorized distributors approved by Mallinckrodt or the FDA can legitimately supply TUXARIN ER. Internationally, local regulatory agencies oversee approvals, with local pharmaceutical companies often manufacturing generic equivalents under license.

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Authorized Suppliers and Distributors

1. Mallinckrodt Pharmaceuticals

As the patent holder and original producer, Mallinckrodt remains the primary source for TUXARIN ER within regulated markets. Their distribution network ensures product integrity, adherence to Good Manufacturing Practices (GMP), and compliance with regulatory standards.

2. Licensed Wholesalers and Distributors

Authorized pharmaceutical distributors, such as McKesson, AmerisourceBbergen, and Cardinal Health, stock TUXARIN ER following strict regulatory and contractual compliance. These distributors are vetted through comprehensive regulatory audits to prevent diversion and counterfeit.

3. International Generics Manufacturers

In regions outside North America, local pharmaceutical companies, such as Ethypharm (France), Lupin Limited (India), and Teva Pharmaceutical Industries (Israel), manufacture generic versions of oxycodone ER formulations, often under regulatory approval. These generics, while not branded as TUXARIN ER, are bioequivalent and supplied via licensed channels.

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Legitimate vs. Illicit Sources

Due to the drug’s high potential for abuse, illegal markets often flood with counterfeit or diverted versions. It is imperative for healthcare providers and pharmacies to source TUXARIN ER only through authorized channels:

• Verified Distributors: Confirm that suppliers are licensed and registered with regulatory authorities.
• Authentication Protocols: Utilize tamper-evident packaging and drug verification protocols such as RFID tags or serial number tracking.
• Regulatory Compliance: Ensure suppliers hold necessary licenses, and products bear valid certification labels.

Illicit sources pose substantial risks, including inconsistent potency, contamination, and legal liabilities.

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Regulatory and Licensing Considerations

The legality and availability of TUXARIN ER depend heavily on local regulations:

• United States: Controlled substance (Schedule II), requiring DEA registration and strict distribution controls.
• European Union: Managed under EMA guidelines, with manufacturing approvals aligned with EMA standards.
• Asia and Africa: Varying degrees of regulatory oversight; importation must adhere to local drug control laws.

Suppliers in these regions must maintain licenses and comply with international standards (e.g., GMP, Good Distribution Practice-GDP).

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Emerging Trends in Supply Dynamics

The global opioid supply chain faces increasing scrutiny due to abuse potential. Recent trends include:

• Digital Traceability: Implementation of blockchain and serialization technologies.
• Regulatory Tightening: Enhanced import/export controls to prevent diversion.
• Alternative Sourcing Models: Use of authorized generics and biosimilars to meet demand while ensuring safety.

These trends influence sourcing strategies, emphasizing transparency and compliance.

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Strategic Procurement Recommendations

For stakeholders seeking legitimate suppliers for TUXARIN ER:

• Engage Directly with Manufacturers: Establish direct procurement agreements with Mallinckrodt or local licensed manufacturers.
• Partner with Certified Distributors: Verify credentials and conduct regular audits.
• Leverage Regulatory Databases: Cross-check registration and licensing status through FDA, EMA, or local regulatory agency databases.
• Implement Quality Assurance Protocols: Conduct periodic testing for authenticity, potency, and purity.

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Conclusion

Securing legitimate suppliers for TUXARIN ER involves navigating a complex landscape that balances regulatory compliance, product authenticity, and supply chain integrity. The cornerstone remains engaging with licensed manufacturers and authorized distributors while leveraging technological solutions to prevent counterfeiting. Upholding rigorous standards ensures patient safety and legal adherence, vital in managing high-risk medications like TUXARIN ER.

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Key Takeaways

• Primary Source: Mallinckrodt Pharmaceuticals holds the original patent and manufacturing rights for TUXARIN ER in regulated markets.
• Authorized Channels: Only licensed distributors and pharmacies approved by regulators such as the FDA or EMA should supply TUXARIN ER.
• Geographic Variance: International generic manufacturers produce bioequivalent versions, but sourcing must be regulated and verified.
• Risks of Illicit Markets: Counterfeit and diverted drugs pose significant health and legal risks; strict due diligence is essential.
• Technological Solutions: Serialization, blockchain, and authentication tools enhance supply chain security.

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FAQs

1. How can healthcare providers verify the authenticity of TUXARIN ER supplies?
Providers should verify serial numbers, shelf labels, and packaging against manufacturer records, utilize serialization technology, and source exclusively through authorized distributors registered with regulatory authorities.

2. Are there licensed generic equivalents of TUXARIN ER available internationally?
Yes; multiple generic manufacturers produce oxycodone ER formulations approved within their respective jurisdictions, but these are not branded as TUXARIN ER and must be sourced from licensed suppliers.

3. What regulatory bodies oversee the supply of TUXARIN ER?
In the US, the FDA and DEA regulate its marketing and distribution; in Europe, the EMA and national agencies oversee licensing; other regions rely on respective national health authorities.

4. How does the risk of counterfeit TUXARIN ER impact supply chain decisions?
Counterfeit drugs threaten patient safety and legal compliance; thus, supply chains prioritize traceability, verified licensing, and secure logistics to mitigate risks.

5. What role does technology play in securing legitimate TUXARIN ER supplies?
Technology enables serialization, digital tracking, and blockchain-based verification, improving supply chain transparency and deterring counterfeit distribution.

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Sources:

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. Mallinckrodt Pharmaceuticals official website.
3. WHO guidelines on the regulation of pharmaceuticals and controlled substances.
4. DEA Controlled Substances Act database.
5. EMA Community Register of medicines.