Suppliers and packagers for generic pharmaceutical drug: OXCARBAZEPINE

OXCARBAZEPINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alkem Labs Ltd	OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	213183	ANDA	Ascend Laboratories, LLC	67877-532-58	250 mL in 1 BOTTLE (67877-532-58)	2020-01-01
Amneal Pharms	OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	202961	ANDA	AvPAK	50268-649-30	30 CUP, UNIT-DOSE in 1 TRAY (50268-649-30) / 5 mL in 1 CUP, UNIT-DOSE (50268-649-05)	2023-04-05
Amneal Pharms	OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	202961	ANDA	Amneal Pharmaceuticals LLC	65162-649-48	10 CUP, UNIT-DOSE in 1 TRAY (65162-649-48) / 5 mL in 1 CUP, UNIT-DOSE (65162-649-43)	2012-06-04
Amneal Pharms	OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	202961	ANDA	Amneal Pharmaceuticals LLC	65162-649-78	1 BOTTLE in 1 CARTON (65162-649-78) / 250 mL in 1 BOTTLE	2012-06-04

Suppliers for the Pharmaceutical Drug: Oxcarbazepine

Last updated: July 29, 2025

Introduction
Oxcarbazepine is an antiepileptic medication widely prescribed for managing partial seizures and other neurological conditions. Its growing global demand underscores the importance of reliable suppliers in the pharmaceutical supply chain. This article explores key suppliers of oxcarbazepine, examining their manufacturing capacities, geographic distribution, regulatory status, and strategic significance in the global market.

Overview of Oxcarbazepine Manufacturing
Oxcarbazepine (C15H12N2O2) is synthesized through complex chemical processes that require advanced facilities conforming to Good Manufacturing Practices (GMP). Its production involves key intermediates and catalysts, necessitating specialized suppliers capable of delivering pharmaceutical-grade raw materials and intermediates. The global supply landscape is characterized by a mix of established pharmaceutical manufacturers, contract manufacturing organizations (CMOs), and emerging producers from various regions.

Major Suppliers of Oxcarbazepine

1. Indian Pharmaceutical Manufacturers

India stands as a prominent supplier of generic pharmaceuticals, including oxcarbazepine. Indian firms benefit from cost-effective manufacturing, robust regulatory oversight, and strong export infrastructure.

• Sun Pharmaceutical Industries Ltd.
  A leading global pharma company, Sun Pharma produces oxcarbazepine for international markets. Their manufacturing facilities in India are compliant with US FDA and EU GMP standards, supporting high-quality output.

• Dr. Reddy’s Laboratories
  Reddy’s supplies oxcarbazepine primarily to North America and other developed markets. Their production facilities are certified by international regulators, ensuring high standards.

• Lupin Limited
  Lupin manufactures oxcarbazepine as part of its neurological portfolio, with a focus on regulatory compliance and scalable production to meet global demand.

2. Chinese Pharmaceutical Manufacturers

China has emerged as a significant producer of active pharmaceutical ingredients (APIs), including oxcarbazepine, leveraging low-cost manufacturing and increasing regulatory accreditation.

• Zhejiang Tianyu Pharmaceutical Co., Ltd.
  This company produces pharmaceutical-grade oxcarbazepine and supplies primarily to Asian markets, with some exports to Europe.

• Qingdao G-Pharma Co., Ltd.
  Specializes in APIs and intermediates, offering OEM and OEM services for oxcarbazepine to global clients.

• Shandong Xinhua Pharmaceutical Co., Ltd.
  A key player with capacity for large-scale production of oxcarbazepine, compliant with international GMP standards.

3. European and North American Suppliers

Some European and North American firms engage in the final formulation or wholesale distribution of oxcarbazepine, often sourcing APIs from Asian manufacturers under strict quality controls.

• Hoffmann-La Roche (historically)
  While Roche’s focus has shifted from production, some subsidiaries and licensing partners manufacture and distribute oxcarbazepine in specific regions.

• Teva Pharmaceutical Industries Ltd.
  A global generics leader, Teva sources oxcarbazepine from multiple suppliers to maintain a diversified supply chain, including manufacturing in Asia and Europe.

4. Contract Manufacturing Organizations (CMOs)

Several CMOs serve as key suppliers by producing oxcarbazepine under contract for brand-name and generic drug companies.

• Boehringer Ingelheim (contract manufacturing)
  Offers APIs and finished formulations, emphasizing quality and compliance with international standards.

• Lonza Group
  Provides custom manufacturing services for APIs, including oxcarbazepine, with focus on scaling production and ensuring purity.

Regulatory and Quality Considerations

Manufacturers targeting global markets must secure regulatory approvals from agencies such as the US FDA, EMA, and other national authorities. Quality assurance encompasses rigorous testing for impurities, bioequivalence, and compliance with GMP standards. Suppliers with verified certifications are preferred by pharmaceutical companies aiming to mitigate risks associated with supply chain disruptions and quality lapses.

Geographic Distribution and Strategic Implications

The concentration of oxcarbazepine suppliers in India and China reflects cost advantages and manufacturing capabilities. However, geopolitical factors, regulatory challenges, and intellectual property considerations influence sourcing decisions. European and North American suppliers often serve niche markets or final formulation needs, emphasizing quality and compliance over cost.

This diversified supplier landscape enables pharmaceutical companies to build resilient supply chains, balancing cost, quality, and regulatory requirements. Strategic partnerships with reliable suppliers are crucial to ensuring consistent availability of oxcarbazepine worldwide, especially amid global supply chain disruptions like those witnessed during the COVID-19 pandemic.

Market Dynamics and Future Trends

The global oxcarbazepine market is expected to grow, driven by increasing prevalence of epilepsy and neurological disorders. Supply chain diversification, investment in manufacturing capacity, and technological advancements in synthesis are likely to shape supplier strategies. Additionally, the rise of biosimilar and generic formulations may influence procurement practices, emphasizing the importance of establishing stable supplier relationships.

Key Challenges for Suppliers

• Regulatory Compliance: Maintaining certifications for GMP, ISO, and other standards across regions.
• Quality Assurance: Ensuring consistent purity, potency, and low impurity profiles.
• Supply Chain Stability: Managing geopolitical risks, trade policies, and raw material availability.
• Cost Management: Balancing manufacturing costs with market pricing pressures, especially in generics.

Key Takeaways

• India and China dominate as primary suppliers of oxcarbazepine due to cost efficiencies and manufacturing expertise.
• European and North American suppliers focus on quality, regulatory compliance, and final formulation.
• Diversification across regions mitigates supply risks and supports global distribution.
• Regulatory compliance and certification are critical factors influencing supplier selection.
• Strategic partnerships and contracts with CMOs enhance manufacturing capacity and supply chain resilience.

FAQs

1. What are the leading countries producing oxcarbazepine globally?
India and China are the main producers of oxcarbazepine APIs, leveraging cost-effective manufacturing. European and North American firms primarily handle formulation, distribution, or final assembly.

2. Are there specific regulatory standards suppliers must meet?
Yes, suppliers need GMP certification from agencies like the FDA, EMA, or respective local authorities. Additional certifications such as ISO help ensure quality standards are met.

3. How does supplier diversification impact the supply chain?
Diversification reduces reliance on a single source, decreasing risks from geopolitical issues, regulatory changes, or manufacturing disruptions, thereby ensuring consistent product supply.

4. Can suppliers provide OEM services for oxcarbazepine?
Yes, CMOs often offer OEM services, customizing APIs and formulations according to client specifications, which is common among global pharmaceutical companies.

5. What trends are shaping the future of oxcarbazepine supply?
Growth in neurological disorder treatments, technological advances in synthesis, and increased regulatory stringency are shaping supply strategies. Supply chain resilience via diversification remains a key focus.

Conclusion
The supply landscape for oxcarbazepine is characterized by a diverse array of players spanning Asia, Europe, and North America, highlighted by robust manufacturing capabilities and strict adherence to regulatory standards. As demand continues to grow, strategic sourcing, quality assurance, and supply chain resilience will remain pivotal to ensuring uninterrupted access to this vital antiepileptic medication.

Sources

1. GlobalData Healthcare. "Pharmaceutical Industry Outlook," 2022.
2. US Food and Drug Administration (FDA). "List of Approved Drugs and Manufacturers," 2023.
3. European Medicines Agency (EMA). "Good Manufacturing Practice," 2023.
4. Market research reports on pharmaceutical APIs, 2022-2023.
5. Company websites and public disclosures from Sun Pharma, Dr. Reddy’s, Lupin, Zhejiang Tianyu, Qingdao G-Pharma, and others.