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Suppliers and packagers for NEURONTIN
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NEURONTIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Viatris | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235 | NDA | Parke-Davis Div of Pfizer Inc | 0071-0803-24 | 100 CAPSULE in 1 BOTTLE (0071-0803-24) | 1993-12-30 |
| Viatris | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235 | NDA | Parke-Davis Div of Pfizer Inc | 0071-0805-24 | 100 CAPSULE in 1 BOTTLE (0071-0805-24) | 1993-12-30 |
| Viatris | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235 | NDA | Parke-Davis Div of Pfizer Inc | 0071-0806-24 | 100 CAPSULE in 1 BOTTLE (0071-0806-24) | 1993-12-30 |
| Viatris | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235 | NDA | Viatris Specialty LLC | 58151-281-01 | 100 CAPSULE in 1 BOTTLE (58151-281-01) | 2025-07-10 |
| Viatris | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235 | NDA | Viatris Specialty LLC | 58151-283-01 | 100 CAPSULE in 1 BOTTLE (58151-283-01) | 2025-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Neurontin
Introduction
Neurontin (generic name: gabapentin) is a widely prescribed medication primarily used to manage neuropathic pain, epilepsy, and certain neurological conditions. First approved by the U.S. Food and Drug Administration (FDA) in 1993, gabapentin has seen extensive global adoption, reflecting a complex supply chain comprising multiple manufacturers, generic manufacturers, and distributors. Navigating the supplier landscape for Neurontin is critical for stakeholders involved in procurement, production, and distribution.
Manufacturers of Neurontin
Original Manufacturer: Pfizer
Pfizer Inc. was the original manufacturer of Neurontin, holding the patent until its expiration in 2004. The drug's initial formulation and commercialization were the result of Pfizer’s extensive R&D efforts. Following patent expiration, Pfizer licensed the manufacturing rights to numerous generic pharmaceutical companies, which significantly increased the drug's availability and diversified its supply chain.
Post-Patent Generics Manufacturers
With patent expiry, multiple generics manufacturers entered the market, leveraging their own formulations and manufacturing facilities.
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Teva Pharmaceutical Industries Ltd.
As one of the largest generic drug manufacturers globally, Teva produces gabapentin formulations in various strengths (300 mg, 600 mg, 800 mg). Their global footprint allows broad distribution channels and consistent supply. -
Sun Pharmaceutical Industries Ltd.
An Indian pharmaceutical giant, Sun Pharma manufactures high-quality gabapentin and supplies it across numerous markets, including North America, Europe, and emerging economies. -
Mylan (now part of Viatris Inc.)
Mylan’s gabapentin products are widely distributed in the U.S. and are known for their affordability and availability. -
Sandoz (a Novartis division)
Sandoz supplies gabapentin generics, offering competitive options in various formulations. -
Aurobindo Pharma
Based in India, Aurobindo manufactures gabapentin in different dosages, emphasizing cost-effective production. -
Zydus Cadila
An Indian pharmaceutical firm with a growing presence in the global gabapentin market. -
Torrent Pharmaceuticals
Supplies gabapentin formulations for various regions.
Additional regional and national manufacturers include Hikma Pharmaceuticals (UK), Lupin Limited (India), and Dr. Reddy’s Laboratories (India), each contributing to the global supply network.
Distribution and Supply Chain Dynamics
The supply chain for Neurontin involves multiple layers post-licensing:
- Manufacturing: Both originators and generics produce the active pharmaceutical ingredient (API) and finished dosage forms.
- Distribution Centers: Major pharmaceutical distributors and wholesalers procure from manufacturing plants.
- Distributors: Entities such as McKesson, Cardinal Health, and AmerisourceBergen distribute to hospitals, pharmacies, and clinics.
- Retail and Hospital Pharmacies: Final point of sale for patients.
The global demand for gabapentin continues to fuel supply chain complexities, including raw ingredient sourcing, manufacturing capacity variations, and regulatory harmonization.
Raw Material Suppliers
The API for gabapentin is synthesized through multi-step chemical processes, primarily sourced from chemical manufacturers specializing in pharmaceutical-grade raw materials.
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Major API Suppliers:
Companies such as RSC Pharma, Hikal Ltd., and VHB Life Sciences supply pharmaceutical-grade gabapentin API, often sourcing raw materials from global chemical suppliers or producing the API in-house. -
Key Raw Material Countries:
Predominantly China and India, which dominate active pharmaceutical ingredient supply due to cost efficiency and manufacturing capacity. -
Regulatory Considerations:
Suppliers must adhere to Good Manufacturing Practices (GMP), GMP certification being a requisite for API suppliers supplying to pharmaceutical manufacturers.
Regulatory Impact on Suppliers
Global regulatory frameworks, such as the FDA, EMA, and other national agencies, influence supplier operations:
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FDA Registration:
Most major manufacturers serving the U.S. market are FDA-registered and compliant. -
EMA and International Regulators:
Glyphaben in Europe often sourced from EMA-approved facilities. -
Quality and Compliance:
Variability in manufacturing standards can impact supply consistency and quality assurance.
Market and Competitive Landscape
The gabapentin market is characterized by intense competition among generic manufacturers, with price pressures leading to thin profit margins and reliance on large-scale production. The recent patent cliff has democratized supply sources, reducing dependence on a single provider and enhancing global availability.
Emerging Suppliers and Alternative Sources
- Small and medium enterprises (SMEs) increasingly enter the market, particularly in India and China.
- API synthesis innovations and process improvements can influence sourcing strategies.
- Companies investing in robust quality management systems ensure regulatory compliance, critical for international markets.
Future Supply Trends
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Supply Chain Resilience:
COVID-19 and geopolitical tensions underscore the need for diversified sourcing and regional manufacturing hubs. -
API Manufacturing Capacity Expansion:
Investments in API manufacturing facilities in India and China aim to meet growing global demand. -
Regulatory Stringency:
Tighter regulations promote supplier qualification processes, emphasizing quality, origin traceability, and compliance.
Conclusion
The supply landscape for Neurontin has evolved significantly since patent expiry, marked by a proliferation of manufacturing sources and an expansive global distribution network. Leading generic manufacturers, including Teva, Sun Pharma, Mylan (Viatris), and Sandoz, dominate supply, backed by a robust network of raw material suppliers primarily based in China and India. Ensuring supply stability requires ongoing attention to manufacturing quality, regulatory compliance, and geopolitical developments impacting raw material sourcing and manufacturing capacity.
Key Takeaways
- The post-patent era has diversified Neurontin's supply chain with multiple reputable generic manufacturers.
- India and China are central to active pharmaceutical ingredient supply, necessitating quality and regulatory vigilance.
- Major global distributors facilitate broad market access, ensuring consistent drug availability.
- Supply resilience depends on manufacturing capacity expansion, regulatory adherence, and diversification strategies.
- Stakeholders should monitor technological innovations and geopolitical factors influencing supply dynamics.
FAQs
1. Who are the leading global manufacturers of gabapentin today?
Major players include Teva, Sun Pharma, Mylan (Viatris), Sandoz, and Aurobindo, each with extensive manufacturing capacities and global distribution channels.
2. How does patent expiration impact the supply of Neurontin?
Patent expiry opened the market to numerous generic manufacturers, increasing supply options, reducing prices, and decentralizing production sources.
3. What are the primary countries supplying raw materials for gabapentin?
China and India dominate API production, leveraging lower costs and substantial manufacturing infrastructure, all subject to international quality standards.
4. What regulatory considerations influence gabapentin supply chains?
Regulatory compliance with GMP, FDA registration, and approvals from EMA or other agencies are critical for maintaining supply chain integrity and market access.
5. Are there upcoming trends that could disrupt Neurontin supply?
Yes, including geopolitical tensions, COVID-19 related supply chain disruptions, and regulatory tightening, which could influence manufacturing capacity and raw material sourcing.
Sources:
[1] U.S. FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
[2] Teva Pharmaceuticals. Product portfolio and manufacturing details.
[3] Sun Pharmaceutical Industries Ltd. Annual Reports.
[4] Mylan (Viatris Inc.) Corporate Reports.
[5] Global API market reports and regulatory filings.
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