Suppliers and packagers for GABAPENTIN

GABAPENTIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis Elizabeth	GABAPENTIN	gabapentin	CAPSULE;ORAL	075350	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-075-30	30 CAPSULE in 1 BOTTLE (43353-075-30)	2010-01-23
Actavis Elizabeth	GABAPENTIN	gabapentin	CAPSULE;ORAL	075350	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-075-60	90 CAPSULE in 1 BOTTLE (43353-075-60)	2010-01-23
Actavis Elizabeth	GABAPENTIN	gabapentin	CAPSULE;ORAL	075350	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-081-60	90 CAPSULE in 1 BOTTLE (43353-081-60)	2014-03-17

Suppliers for the Pharmaceutical Drug: GABAPENTIN

Last updated: July 28, 2025

Introduction

GABAPENTIN, a widely prescribed anticonvulsant and neuropathic pain agent, is subject to extensive global supply chains driven by high demand in both developed and emerging markets. Originally developed as an analogue of gamma-aminobutyric acid (GABA), it is a generic medication used for epilepsy, neuropathic pain, and off-label indications. The complexity of its manufacturing process and regulatory considerations influence the landscape of its suppliers. This report provides a comprehensive overview of key suppliers for GABAPENTIN, analyzing their manufacturing capacities, geographic distribution, regulatory status, and market influence.

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Global Manufacturing Landscape of GABAPENTIN

The manufacturing of GABAPENTIN involves complex synthetic routes, often requiring high-purity intermediates, precise control over enantiomeric purity, and strict regulatory adherence to Good Manufacturing Practices (GMP). The supply chain is characterized by a blend of original innovator companies, large generic drug manufacturers, and emerging generic producers in diverse regions.

The primary suppliers are grouped into three categories:

1. Original Innovator Manufacturers: Coherus Biosciences, Pfizer, Parke-Davis (a division of Pfizer), and Union Carbide (original patent holders).
2. Major Generic Manufacturers: Teva Pharmaceutical Industries, Mylan (now part of Viatris), Sun Pharmaceutical, Dr. Reddy’s Laboratories, and Cipla.
3. Emerging and Regional Suppliers: Various regional entities in India, China, and other Asian countries.

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Key Suppliers

1. Pfizer (Eli Lilly & Co. historically)

Although Pfizer was initially associated with the development of GABAPENTIN, it no longer dominates the patent space. However, Pfizer's legacy manufacturing facilities contributed significantly to early supplies, and the company holds critical patents and licensing rights during patent exclusivity periods. Currently, Pfizer's role is more strategic, involving licensing and quality oversight rather than active production of generic GABAPENTIN.

2. Teva Pharmaceuticals

Teva is the largest generic pharmaceutical manufacturer globally with significant capabilities in producing GABAPENTIN. The company operates multiple manufacturing sites in Israel, India, and the USA. Teva's global supply chain for GABAPENTIN is extensive, supported by robust R&D, quality assurance measures, and a broad distribution network.

3. Mylan (a Viatris entity)

Mylan, now part of Viatris after the 2020 merger with Pfizer's Upjohn unit, has a sizable market share in GABAPENTIN. The company’s manufacturing footprint spans India, Europe, and North America, with facilities accredited under major regulatory agencies such as the FDA, EMA, and WHO. Mylan's focus on cost-effective production ensures competitive pricing and uninterrupted supply.

4. Sun Pharmaceutical Industries Ltd.

India's Sun Pharma is a leading producer of GABAPENTIN, leveraging its extensive domestic manufacturing facilities and export-oriented operations. Its supply chain benefits from Indian pharmaceutical sector advantages, including cost-efficiency and access to high-quality raw materials, ensuring its significant contribution to global GABAPENTIN supplies.

5. Dr. Reddy’s Laboratories

Another major Indian player, Dr. Reddy's, operates several manufacturing sites with GMP compliance, supplying GABAPENTIN across numerous markets. Its strategic focus on export markets, including the US and Europe, makes it a critical supplier.

6. Cipla Ltd.

Cipla’s manufacturing facilities predominantly in India supply GABAPENTIN globally, emphasizing affordability and quality. The company's extensive distribution network enables rapid market penetration, especially in emerging economies.

7. Other Notable Suppliers

Regional manufacturers in China, Brazil, and additional Indian generic producers (e.g., Aurobindo Pharma, Laurus Labs) contribute substantially to the supply landscape. These suppliers often focus on generics and biosimilar markets, expanding the global availability of GABAPENTIN.

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Manufacturing and Regulatory Considerations

The production of GABAPENTIN entails rigorous quality controls due to its critical therapeutic indications. Suppliers must adhere to GMP standards, with many facilities accredited by the FDA, EMA, or WHO. The global supply chain is sensitive to regulatory shifts; for instance, changes in international standards or validation requirements can influence the production capacities of regional suppliers.

Supply chain disruptions, such as those caused by the COVID-19 pandemic, have highlighted vulnerabilities in the reliance on specific geographic regions—particularly India and China—which are central to GABAPENTIN manufacturing.

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Market Dynamics and Supplier Influence

The extensive generics market, driven by patent expirations in the early 2000s, resulted in numerous suppliers entering the space. Teva and Mylan historically held dominant positions, with aggressive pricing strategies fostering competitive market dynamics. Recent trends include consolidation through mergers and acquisitions, such as Viatris' formation, which impacts market share distribution.

Emerging suppliers increasingly participate in regional markets, complying with regional regulatory authorities to expand their footprint. The convergence of quality standards and capacity expansion efforts point toward a resilient but complex global supply network.

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Supply Chain Risks and Opportunities

Risks include:

• Regulatory non-compliance or changes in GMP standards.
• Geopolitical tensions affecting raw material import/export.
• Manufacturing capacity constraints due to supply chain disruptions.
• Quality variability among regional suppliers.

Opportunities involve:

• Diversification through multiple regional suppliers.
• Investment in manufacturing modernization to meet stringent standards.
• Strategic stockpiling by distributors and health authorities.
• Adoption of advanced synthetic technologies to improve yield and purity.

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Conclusion

The global supply chain for GABAPENTIN is broadly developed, dominated by Indian, Israeli, and international generic pharmaceutical manufacturers, with significant contributions from MNCs like Teva, Mylan/Viatris, and Sun Pharma. Ensuring supply stability hinges on continuous compliance with regulatory standards, capacity expansion, and diversification. Ongoing geopolitical and pandemic-related disruptions necessitate proactive sourcing strategies.

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Key Takeaways

• Diversify Supplier Base: To mitigate geopolitical and regulatory risks, companies should engage multiple suppliers across regions.
• Ensure Regulatory Compliance: Suppliers must maintain GMP standards recognized worldwide to prevent supply interruptions.
• Monitor Capacity and Quality: Regular assessment of manufacturing capacities and quality controls is crucial amid increasing demand.
• Leverage Regional Strengths: Indian and Chinese manufacturers offer cost efficiencies and scale, but synchronization with international standards is vital.
• Plan for Supply Chain Risks: Strategic stockpiling and supply chain analytics are essential to buffer against disruptions.

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FAQs

1. Who are the leading global suppliers of GABAPENTIN?
Teva, Mylan (Viatris), Sun Pharma, and Dr. Reddy’s are among the top global producers, largely based in Israel and India, with extensive manufacturing capacities.

2. What regions dominate GABAPENTIN manufacturing?
India and Israel are primary manufacturing hubs due to their established pharmaceutical industries and cost advantages, with additional contributions from China and other emerging markets.

3. How do regulatory standards impact GABAPENTIN supply?
Strong compliance with GMP and other international standards ensures quality and continuous supply, while non-compliance can lead to production halts or market access restrictions.

4. Are there supply risks associated with GABAPENTIN?
Yes, supply can be affected by raw material shortages, manufacturing capacity constraints, regulatory changes, and geopolitical tensions, especially in regions heavily reliant on specific suppliers.

5. How can stakeholders ensure a stable GABAPENTIN supply chain?
Diversification of suppliers, proactive regulatory compliance, investment in capacity expansion, and strategic stockpiling can enhance supply resilience.

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References

1. [1] Teva Pharmaceutical Industries. Annual Reports and Manufacturing Data.
2. [2] Mylan (Viatris) Corporate Reports. Global Supply Chain Overview.
3. [3] Sun Pharmaceutical Industries Ltd. Manufacturing & Quality Standards.
4. [4] U.S. Food and Drug Administration (FDA). GMP Guidelines for Pharmaceuticals.
5. [5] Indian Pharmaceutical Industry Insights. Market Dynamics and Regional Suppliers.