Suppliers and packagers for tegretol-xr

tegretol-xr

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234	NDA	Novartis Pharmaceuticals Corporation	0078-0510-05	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0510-05)	1996-03-25
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234	NDA	Novartis Pharmaceuticals Corporation	0078-0511-05	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0511-05)	1996-03-25
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234	NDA	Novartis Pharmaceuticals Corporation	0078-0512-05	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0512-05)	1996-03-25

Suppliers for the Pharmaceutical Drug: TEGRETOL-XR

Last updated: July 28, 2025

Introduction

TEGRETOL-XR, the extended-release formulation of carbamazepine, is a critical pharmaceutical indicated primarily for epilepsy, bipolar disorder, and trigeminal neuralgia. Given its complex formulation and regulatory landscape, the procurement landscape comprises a diverse array of suppliers, from original manufacturers to generic producers. Precision in sourcing, regulatory compliance, and quality assurance are pivotal for stakeholders, including healthcare providers, distributors, and regulators. This report examines the current suppliers for TEGRETOL-XR, analyzing production sources, market dynamics, and strategic considerations.

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1. Origin and Manufacturing Background of TEGRETOL-XR

TEGRETOL-XR is a branded pharmaceutical, initially developed and marketed by Novartis. As a patent-protected medication until its patent expiry, Novartis was the primary supplier during its exclusivity period. Post-patent expiration, the manufacturing rights either shifted to generic manufacturers or are licensed through authorized producers. The extended-release formulation's complexity necessitates stringent manufacturing processes, including controlled-release matrix technology and precise dosing accuracy.

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2. Original Manufacturer and Patent-Exclusive Suppliers

Novartis AG has historically been the sole producer of TEGRETOL-XR, leveraging proprietary technologies to ensure bioavailability and stability. During patent exclusivity, Novartis maintained global manufacturing facilities, including sites in Switzerland, the United States, and emerging markets, dictated by intellectual property rights and regulatory approvals.

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3. Market Entry of Generic Suppliers Post-Patent Expiry

a. Emergence of Generics

Following patent expiry around 2017–2018 in many jurisdictions, multiple generic pharmaceutical firms have entered the TEGRETOL-XR market, utilizing bioequivalent formulations of carbamazepine extended-release.

b. Major Generic Manufacturers

• Mylan (now Viatris): One of the leading producers of generic carbamazepine XR, with manufacturing plants certified under GMP standards. Their generic formulations are widely available in North America and Europe, often marketed under various domestic labels.

• Sandoz (a Novartis division): As a division of Novartis itself, Sandoz supplies generic carbamazepine formulations, including extended-release variants, sometimes under authorized generics.

• Teva Pharmaceutical Industries: A global leader in generic pharmaceuticals, Teva supplies extended-release carbamazepine to numerous markets, emphasizing manufacturing quality and supply stability.

• Hetero Labs: Based in India, Hetero produces generic carbamazepine XR, primarily for Asian and African markets, with adherence to international GMP standards.

• Aurobindo Pharma: Another Indian-based manufacturer offering generic carbamazepine XR formulations with certifications fitting global standards.

c. Market-Specific Suppliers

In emerging markets such as Brazil, China, and South Africa, regional pharmaceutical firms supply TEGRETOL-XR under local regulatory approvals, often sourcing material from international or regional API producers.

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4. API Suppliers for TEGRETOL-XR

The core of TEGRETOL-XR production hinges on high-quality carbamazepine APIs, with major API suppliers including:

• Cambridge Commodities (UK): Procures pharmaceutical-grade carbamazepine for their formulations.

• Hikal Ltd. (India): Provides APIs compliant with GMP standards used by multiple generic manufacturers.

• Shandong Xinhua Pharmaceutical (China): Supplies APIs primarily for the Asian markets.

• BASF and Merck KGaA: Historically involved in carbamazepine APIs, though their current roles vary with market dynamics.

Securing APIs from reliable, certified suppliers is essential for downstream quality assurance of TEGRETOL-XR.

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5. Supply Chain and Regulatory Considerations

The complex manufacturing process for TEGRETOL-XR demands adherence to numerous regulatory standards, including FDA, EMA, and other regional authorities. Licensed and approved manufacturing facilities are crucial, especially for generics targeting high-regulation markets. The supply chain integrity is increasingly monitored via serialization and track-and-trace systems, especially post-GSTP (Good Supply Practice) regulations.

Manufacturers also face challenges related to API shortages, compliance costs, and patent litigations, which influence supplier availability and market prices.

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6. Strategic Sourcing and Market Trends

a. Contract Manufacturing Organizations (CMOs): Many pharmaceutical firms outsource manufacturing of TEGRETOL-XR to CMOs with proven technology and regulatory approvals, aiding scalability amid demand fluctuations.

b. Industry Consolidation: Patent expiries and competitive pressures have led to industry consolidation, with major generic firms expanding their portfolios for carbamazepine XR.

c. Biosimilar and Alternative Formulations: While no biosimilars exist for TEGRETOL-XR, ongoing R&D aims to develop alternative delivery systems, potentially impacting supply sourcing strategies.

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7. Challenges and Risks in Sourcing TEGRETOL-XR

• Regulatory Variability: Differing regional requirements may limit supplier options.

• API Shortages: Global API supply disruptions impact generic manufacturers' manufacturing capabilities.

• Intellectual Property: Patent litigation and patent protections can restrict licensing opportunities and influence supplier selection.

• Quality Assurance: Ensuring consistency across multiple suppliers necessitates rigorous quality control protocols.

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8. Conclusion

The supply landscape for TEGRETOL-XR has transitioned from a monopoly controlled by Novartis to a diversified supplier network comprising original and multiple generic manufacturers. Current key suppliers include:

• Novartis (original manufacturer) and authorized generics

• Leading generics: Viatris (Mylan), Sandoz, Teva, Hetero, and Aurobindo

• API suppliers: Shandong Xinhua, Hikal Ltd., and others

Procurement strategies involve meticulous evaluation of manufacturing standards, regulatory approvals, and supply stability. As the market evolves, ongoing industry consolidation and technological advances will shape future supplier dynamics.

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Key Takeaways

• Market Dynamics: Post-patent expiry, the TEGRETOL-XR market is dominated by multiple generic suppliers, expanding access and market competition.

• Quality and Regulatory Compliance: Ensuring consistent product quality requires suppliers to meet stringent regional standards, particularly GMP certification.

• Supply Chain Risks: API shortages and regulatory hurdles pose ongoing risks; diversifying supplier bases enhances resilience.

• Strategic Sourcing: Engaging with authorized manufacturers and reputable API suppliers is essential for maintaining product integrity.

• Innovation Impact: Advancements in drug delivery systems may influence future formulations and supply sources.

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FAQs

1. Who are the primary suppliers of TEGRETOL-XR globally?
The primary suppliers include Novartis (original manufacturer and authorized generics), Viatris (formerly Mylan), Sandoz, Teva, Hetero, and Aurobindo. They supply both branded and generic extended-release carbamazepine formulations.

2. Are there regional differences in TEGRETOL-XR suppliers?
Yes. While global manufacturers serve widespread markets, regional firms in Asia, Africa, and Latin America supply TEGRETOL-XR tailored to local regulatory standards, often sourcing API from regional or international suppliers.

3. What role do API suppliers play in TEGRETOL-XR manufacturing?
API suppliers like Hikal Ltd. and Shandong Xinhua Pharmaceuticals provide the carbamazepine raw material, critical for ensuring the quality, consistency, and supply stability of TEGRETOL-XR.

4. How has patent expiry affected the supplier landscape?
Patent expiry has opened the market to numerous generic manufacturers, increasing the number of suppliers but also emphasizing the importance of quality, regulatory adherence, and supply security.

5. What are the key challenges in sourcing TEGRETOL-XR?
Challenges include API shortages, regulatory compliance, patent litigations, and maintaining consistent manufacturing quality — all of which require vigilant supplier vetting and diversified sourcing strategies.

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References

[1] Novartis Pharmaceuticals. TEGRETOL-XR Product Information.
[2] U.S. Food and Drug Administration (FDA). Approved Drug Products: Carbamazepine Extended-Release.
[3] Market reports on generic pharmaceuticals industry (2018-2023).
[4] Global API suppliers directory.
[5] Regulatory guidelines for pharmaceutical manufacturing standards (GMP).