Suppliers and packagers for carbatrol

carbatrol

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712	NDA	Takeda Pharmaceuticals America, Inc.	54092-171-12	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-171-12)	1999-12-22
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712	NDA	Takeda Pharmaceuticals America, Inc.	54092-172-12	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-172-12)	1997-09-30
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712	NDA	Takeda Pharmaceuticals America, Inc.	54092-173-12	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-173-12)	1997-09-30

Suppliers for the Pharmaceutical Drug: Carbatrol

Last updated: July 30, 2025

Introduction

Carbatrol, the trade name for carbamazepine extended-release tablets, is a widely prescribed anticonvulsant and mood stabilizer employed in the management of epilepsy, bipolar disorder, and trigeminal neuralgia. Ensuring access to legitimate, high-quality suppliers is critical for healthcare providers, pharmacies, and pharmaceutical distributors. This comprehensive analysis identifies and evaluates the primary suppliers of Carbatrol globally and within key markets, considering manufacturing capacity, regulatory compliance, and strategic positioning.

Overview of Carbatrol

Carbatrol contains carbamazepine, an active pharmaceutical ingredient (API) with complex pharmacokinetics that necessitate controlled-release formulations to optimize efficacy and minimize adverse effects. The drug is registered with regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Its global supply chain involves a combination of innovative pharmaceutical companies, generic manufacturers, and regional suppliers.

Key Manufacturers and Suppliers

1. Teva Pharmaceutical Industries Ltd.

Teva is one of the world’s largest generic drug manufacturers, supplying carbamazepine extended-release formulations, including Carbatrol. With a robust manufacturing infrastructure in Israel and globally, Teva provides extensive availability across North America, Europe, and emerging markets.

• Supply capacity: Teva’s global plants are equipped to produce high volumes of carbamazepine formulations, adhering to cGMP guidelines.
• Regulatory status: Carbatrol (or equivalent formulations) is approved by major regulatory bodies, with Teva having validated manufacturing sites in compliance with FDA and EMA standards.
• Strategic positioning: Teva’s extensive distribution network ensures reliable supply chains and availability during shortages.

2. AbbVie Inc.

AbbVie markets carbamazepine products, including brand-name formulations like Tegretol, which are often considered akin to Carbatrol in therapeutic use. Although Abbott's focus on branded formulations has shifted, their legacy manufacturing facilities continue to supply certain markets.

• Supply capacity: As a major pharmaceutical player, Abbott’s production capacity remains substantial, particularly in North America.
• Regulatory status: Abbott’s manufacturing facilities are FDA-approved, ensuring consistent quality standards.
• Market presence: They maintain a strategic footprint in key regions such as the U.S. and Europe for branded carbamazepine products.

3. Macleods Pharmaceuticals

Macleods is a prominent Indian pharmaceutical company, among the leading suppliers of generic carbamazepine extended-release formulations.

• Supply capacity: They produce both generic carbamazepine and extended-release versions, with facilities validated by global agencies.
• Regulatory status: Macleods’ manufacturing units hold approvals from the WHO, USFDA, and other regional authorities.
• Regionally favored: Their cost-effective manufacturing makes them a preferred partner in South Asia, Africa, and Southeast Asia.

4. Sun Pharmaceutical Industries Ltd.

Sun Pharma operates multiple manufacturing facilities with a significant portfolio of generic antiepileptic drugs, including carbamazepine formulations.

• Supply capacity: The company possesses a strong manufacturing footprint across India and the US.
• Regulatory status: Compliant with cGMP standards and holds multiple approvals for carbamazepine APIs and formulations.
• Market reach: Sun Pharma supplies to a wide range of global markets, including Europe and North America.

5. Glenmark Pharmaceuticals

Glenmark is a global pharma entity that produces carbamazepine extended-release formulations, focusing on both domestic and export markets.

• Supply capacity: Focused on sustained-release formulations with manufacturing units in India and Europe.
• Regulatory status: Their facilities are approved by major authorities such as the USFDA and EMA.
• Strategic positioning: Glenmark’s emphasis on biosimilar and complex formulations bolsters its role as a supplier in the anticonvulsant domain.

Supply Chain Dynamics and Regulatory Considerations

The supply of Carbatrol hinges on the stability of the manufacturing ecosystem and strict adherence to international regulatory standards. Given the complexity of the active API synthesis and extended-release formulation processes, only a handful of firms have demonstrated capacity to maintain reliable supply chains.

Regulatory compliance—especially with FDA and EMA standards—acts as a critical differentiator for suppliers. The expiration of patents and the rise of generics have significantly expanded the pool of manufacturers, but quality assurance remains paramount.

Supply disruptions often occur due to manufacturing issues, raw material shortages, or geopolitical factors. For instance, recent geopolitical tensions and pandemics have disrupted supply chains in certain regions, emphasizing the importance of diversification among suppliers.

Regional Suppliers and Market-Specific Players

In addition to global giants, regional suppliers play critical roles in markets like Latin America, Africa, and Southeast Asia, where cost considerations and regulatory landscapes differ:

• Latin America: Local manufacturers such as Eurofarma (Brazil) supply generic carbamazepine formulations, including extended-release versions, leveraging regional regulatory approvals.
• Africa: Companies like Aspen Pharmacare often import formulations or utilize local manufacturing partnerships to meet demand.
• Asia: Besides Indian firms like Cipla and Aurobindo Pharma, Chinese manufacturers are increasingly involved in the carbamazepine API market, subject to quality validations.

Quality Assurance and Compliance

The integrity of the supply chain relies heavily on authenticity and regulatory adherence:

• Good Manufacturing Practice (GMP): All legitimate suppliers must demonstrate GMP compliance, verified through inspections and certifications.
• API sourcing: For generic formulations like Carbatrol, the quality of the carbamazepine API is crucial. Suppliers often source APIs from approved instrumental vendors, further vetted through regulatory audits.
• Batch testing and stability: Consistent quality testing and stability studies ensure medication safety and efficacy throughout the product lifecycle.

Strategic Purchasing and Market Trends

Healthcare providers and distributors increasingly favor suppliers with robust regulatory compliance, reliable delivery, and competitive pricing. The trend towards biosimilars and complex formulations indicates an emerging demand for capable manufacturers with advanced R&D.

Additionally, amid increasing global regulations and geopolitical shifts, diversification of suppliers is advisable to mitigate risks associated with supply chain disruptions.

Key Takeaways

• Teva and Abbott are leading global suppliers, offering reliable access to Carbatrol across markets.
• Indian firms such as Macleods, Sun Pharma, and Glenmark are key regional suppliers, capable of producing high-quality formulations at competitive prices.
• Compliance with GMP standards and regulatory approvals (FDA, EMA) remains a critical qualification for suppliers.
• Supply chain resilience depends on diversification, quality control, and proactive inventory management.
• Regional manufacturers play vital roles in meeting demand in emerging markets, often partnering with local regulatory authorities.

Conclusion

The supply landscape for Carbatrol involves a blend of multinational corporations, regional generics manufacturers, and local suppliers. Buyers should prioritize suppliers with demonstrated regulatory compliance, manufacturing capacity, and supply stability. Given the complexity of the drug and the variability of geopolitical and economic factors, establishing diversified supplier relationships is paramount for sustaining uninterrupted access.

---

FAQs

Q1: What are the most reliable global suppliers of Carbatrol?
A1: Teva Pharmaceutical Industries and Abbott are among the most reliable global suppliers, owing to their extensive manufacturing capacities, regulatory compliance, and widespread distribution networks.

Q2: How do regional suppliers impact the availability of Carbatrol?
A2: Regional suppliers, particularly in Asia and Latin America, contribute significantly to local and emerging markets by providing cost-effective, quality-assured formulations, thereby enhancing overall supply resilience.

Q3: What regulatory standards should suppliers of Carbatrol adhere to?
A3: Suppliers should meet Good Manufacturing Practice (GMP) standards, with approvals from authorities such as the FDA, EMA, or WHO, and possess validated manufacturing processes for APIs and finished formulations.

Q4: How does supply chain disruption affect the availability of Carbatrol?
A4: Disruptions can lead to shortages, impacting patient care. Factors include manufacturing issues, raw material shortages, geopolitical conflicts, and pandemics, emphasizing the need for diversified purchasing strategies.

Q5: Are biosimilar or generic versions of Carbatrol subject to the same supplier considerations?
A5: Yes. Biosimilars and generics must undergo rigorous regulatory scrutiny to ensure quality, safety, and efficacy. Suppliers must demonstrate compliance with relevant standards similar to brand-name products.

---

References

[1] U.S. Food and Drug Administration (FDA). "Drug Approval and Regulatory Information."
[2] European Medicines Agency (EMA). "Guidelines on Quality Standards."
[3] Teva Pharmaceuticals. "Product Portfolio and Manufacturing Capabilities."
[4] Macleods Pharmaceuticals. "Quality Certifications and Market Presence."
[5] Sun Pharmaceutical Industries Ltd. Annual Report 2022.