Suppliers and packagers for KARBINAL ER

KARBINAL 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
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556	NDA	Aytu Therapeutics, LLC	23594-101-01	2 BOTTLE, PLASTIC in 1 CARTON (23594-101-01) / 30 mL in 1 BOTTLE, PLASTIC	2014-01-03
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556	NDA	Aytu Therapeutics, LLC	23594-101-05	480 mL in 1 BOTTLE, PLASTIC (23594-101-05)	2014-01-03
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556	NDA AUTHORIZED GENERIC	Neos Therapeutics, LP	62542-101-05	480 mL in 1 BOTTLE, PLASTIC (62542-101-05)	2024-06-01

Suppliers for the Pharmaceutical Drug: KARBINAL ER

Last updated: August 1, 2025

Introduction

KARBINAL ER (carbamazepine extended-release) is a widely prescribed antiepileptic medication used to control seizures, neuralgias, and mood disorders. As a critical component in managing neurological conditions, its production and supply chain integrity are essential for patient safety and therapeutic efficacy. Understanding the landscape of suppliers involved in the manufacturing of KARBINAL ER is vital for healthcare providers, pharmaceutical distributors, and regulatory agencies aiming to ensure consistent drug availability and compliance with quality standards.

Overview of KARBINAL ER

KARBINAL ER is a proprietary formulation developed by Novartis Pharmaceuticals, offering extended-release properties that facilitate once-daily dosing, improved patient adherence, and steady plasma drug levels. Its active pharmaceutical ingredient (API), carbamazepine, must meet stringent purity and stability requirements, emphasizing the importance of sourcing from reputable suppliers and manufacturers.

Global Manufacturing and Supply Chain

The supply of KARBINAL ER hinges on a complex network of API producers, formulation facilities, and packaging entities across multiple regions. Key players include:

1. Active Pharmaceutical Ingredient (API) Suppliers

The core of KARBINAL ER production is carbamazepine, a BCS Class II molecule, which demands high-quality synthesis and purification processes. Several API manufacturers supply carbamazepine for KARBINAL ER, some of which are:

• Zhangzhou Qianjin Pharmaceutical Co., Ltd. (China): One of the prominent API producers known for its production of carbamazepine complying with international GMP standards. The company supplies raw carbamazepine to various formulation facilities globally.

• HMG (Hovione) (Portugal/Hong Kong): A major API supplier providing high-quality carbamazepine with a focus on compliance and consistent supply.

• Sun Pharmaceutical Industries Ltd. (India): One of the largest generic pharmaceutical companies, producing carbamazepine API for multiple formulations, including extended-release versions.

• Mitsubishi Tanabe Pharma Corporation (Japan): Engaged in the synthesis of carbamazepine APIs meeting high purity standards suitable for neurological medications.

• Alphapharm (Australia): Offers carbamazepine API, mainly for regional markets with strict quality controls.

Note: Many manufacturers are subject to regulatory audits, and their API quality must align with the specifications approved by regulatory authorities such as the FDA, EMA, or PMDA.

2. Formulation and Packaging

Once API sourcing is secured, Novartis’s manufacturing facilities undertake formulation, blending, granulation, and pressing into the extended-release tablet form. These facilities are primarily located in:

• Switzerland: Novartis's global headquarters and primary manufacturing site for KARBINAL ER, adhering to stringent GMP standards.

• India: Contract manufacturing organizations (CMOs) that produce the final product under Novartis’s specifications.

• European Union: Additional manufacturing sites licensed to produce KARBINAL ER for regional markets, ensuring compliance with local regulations.

3. Regulatory and Contract Manufacturing Partners

Novartis collaborates with several CDMOs (Contract Development and Manufacturing Organizations) to scale production and meet global demand:

• Patheon (Thermo Fisher Scientific): Known for its formulation development and manufacturing expertise across complex solid oral dosage forms.

• Recipharm: Provides formulation development and manufacturing services for extended-release tablets.

• Siegfried AG: Offers manufacturing capacity for controlled-release formulations compliant with pharmaceutical industry standards.

Supply Chain Challenges and Considerations

The supply chain for KARBINAL ER faces multiple challenges, including:

• Raw Material Shortages: Fluctuations in carbamazepine API supply due to geopolitical issues, regulatory delays, or natural disasters potentially disrupt production.

• Quality Assurance: Ensuring consistent API purity and stability across batches is critical; failures can lead to recalls or shortages.

• Regulatory Compliance: Regional manufacturing sites must meet varying regulatory standards, necessitating rigorous audits and certifications.

• Manufacturing Capacity Constraints: The global demand for carbamazepine and similar antiepileptics can strain production capacity, especially during pandemics or supply shocks.

Market Dynamics and Supplier Trends

Recent market analyses indicate an increased trend toward diversification of API sources to mitigate risks. This includes expanding partnerships with emerging manufacturers in Asia and Eastern Europe, which often offer cost advantages but must meet strict quality controls. Additionally, patent expirations for some carbamazepine formulations have spurred generic manufacturers to enter the market, influencing supplier dynamics and pricing.

Regulatory and Quality Assurance Frameworks

Suppliers of carbamazepine API and KARBINAL ER must adhere to:

• GMP (Good Manufacturing Practices): Ensures API and finished product quality.

• ICH Guidelines: Promotes uniformity in pharmaceutical product testing and validation.

• USFDA/EMA Approvals: Critical for international markets, requiring detailed documentation and ongoing compliance.

The transparency and traceability of the supply chain are vital, especially considering the global landscape's regulatory scrutiny.

Strategic Implications for Stakeholders

Healthcare providers should evaluate the supplier’s regulatory history, quality certifications, and manufacturing capacity to mitigate shortages. Distributors need to maintain diversified supplier portfolios to hedge against regional disruptions. Regulatory authorities should continuously monitor API and finished drug manufacturing compliance to prevent shortages and safeguard patient health.

Conclusion

The supply of KARBINAL ER hinges on a globally interconnected network of API producers, formulation manufacturers, and regulatory bodies. Prominent API suppliers such as Zhangzhou Qianjin, HMG (Hovione), Sun Pharma, and Mitsubishi Tanabe play central roles. Ensuring supply chain resilience involves multi-tiered strategies encompassing quality assurance, diversified sourcing, and regulatory compliance—critical for uninterrupted access to this vital neurological medication.

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Key Takeaways

• Diversification of API sources reduces supply chain risks and enhances global availability of KARBINAL ER.
• Regulatory compliance and quality assurance are paramount in maintaining drug safety and efficacy.
• Strategic partnerships with reputable CMOs and API manufacturers streamline production and ensure consistent supply.
• Monitoring geopolitical, regulatory, and manufacturing capacity trends allows stakeholders to proactively manage shortages.
• Transparency and traceability within the supply chain bolster confidence among healthcare providers and regulators.

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FAQs

1. Who are the main suppliers producing carbamazepine API for KARBINAL ER?

Major API suppliers include Zhangzhou Qianjin Pharmaceutical (China), HMG (Hovione), Sun Pharmaceutical Industries (India), and Mitsubishi Tanabe Pharma (Japan). These companies are selected based on their compliance with international GMP standards and quality certifications.

2. How does Novartis control the quality of the API used in KARBINAL ER?

Novartis enforces rigorous supplier qualification processes, audits, and contractual quality agreements. The company conducts in-house quality testing and requires API batch-release documentation to ensure adherence to specified purity and stability standards.

3. What are the risks associated with the current supply chain for KARBINAL ER?

Risks include raw material shortages, geopolitical disruptions, manufacturing capacity limitations, and regulatory delays. These factors can lead to supply shortages and impact patient access.

4. Are there regional differences in suppliers for KARBINAL ER?

Yes. While Switzerland and Europe supply the finished product for regional markets, many APIs are sourced from Asian suppliers, reflecting global manufacturing trends and cost considerations.

5. How can healthcare providers mitigate potential shortages of KARBINAL ER?

Providers should work with multiple distributors, monitor supply chain updates, and advocate for diversified sourcing. Additionally, they should maintain communication with regulatory bodies and manufacturers to anticipate and manage shortages proactively.

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Sources:

[1] Novartis Pharmaceuticals. KARBINAL ER Product Information.
[2] Hovione. API Production Capabilities.
[3] Sun Pharmaceutical Industries. API Portfolio.
[4] Regulatory filings and GMP certifications.
[5] Industry market analysis reports on API supply chains.