Suppliers and packagers for pregabalin

pregabalin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Adaptis	PREGABALIN	pregabalin	CAPSULE;ORAL	216197	ANDA	MARKSANS PHARMA LIMITED	25000-179-07	90 CAPSULE in 1 BOTTLE (25000-179-07)	2022-08-01
Adaptis	PREGABALIN	pregabalin	CAPSULE;ORAL	216197	ANDA	MARKSANS PHARMA LIMITED	25000-180-07	90 CAPSULE in 1 BOTTLE (25000-180-07)	2022-08-01
Adaptis	PREGABALIN	pregabalin	CAPSULE;ORAL	216197	ANDA	MARKSANS PHARMA LIMITED	25000-181-07	90 CAPSULE in 1 BOTTLE (25000-181-07)	2022-08-01
Adaptis	PREGABALIN	pregabalin	CAPSULE;ORAL	216197	ANDA	MARKSANS PHARMA LIMITED	25000-182-07	90 CAPSULE in 1 BOTTLE (25000-182-07)	2022-08-01
Adaptis	PREGABALIN	pregabalin	CAPSULE;ORAL	216197	ANDA	MARKSANS PHARMA LIMITED	25000-183-07	90 CAPSULE in 1 BOTTLE (25000-183-07)	2022-08-01

Suppliers for the Pharmaceutical Drug: Pregabalin

Last updated: July 28, 2025

Introduction

Pregabalin, marketed under brand names such as Lyrica, is a widely prescribed anxiolytic and anticonvulsant medication primarily used to treat neuropathic pain, epilepsy, and generalized anxiety disorder. Originally developed by Pfizer, pregabalin has gained extensive market acceptance due to its efficacy and safety profile. As demand for pregabalin rises globally, manufacturers and suppliers play a critical role in ensuring consistent supply, quality, and regulatory compliance. This article explores the key suppliers for pregabalin, their manufacturing credentials, market positions, and the implications for stakeholders in the pharmaceutical supply chain.

Global Manufacturing Landscape

Major Pharmaceutical Companies Producing Pregabalin

Initially developed and marketed by Pfizer, pregabalin’s manufacturing landscape has expanded significantly over the last decade. While Pfizer retained a dominant market share early on, generic manufacturers now produce most of the global supply, driven by patent expirations and increasingly stringent patent protections.

Pfizer Inc. remains a primary licensed producer of branded pregabalin, adhering to rigorous quality and regulatory standards. However, the expiration of Pfizer’s patent in many jurisdictions has opened the door for multiple generic manufacturers, dramatically increasing supply diversity and competitive pricing.

Generic Manufacturers and Key Suppliers

The introduction of generics has altered the pregabalin supply landscape markedly. Leading generic manufacturers include:

• Teva Pharmaceutical Industries Ltd. (Israel): One of the world's largest generic drug manufacturers, Teva produces pregabalin in multiple regions, ensuring broad market coverage. Their manufacturing facilities uphold Good Manufacturing Practices (GMP) and comply with international regulatory standards [1].

• Mylan N.V. (Now part of Viatris): As a global leader in generics, Mylan supplies pregabalin products across numerous markets, especially North America, Europe, and emerging economies.

• Sun Pharmaceutical Industries Ltd. (India): As one of India's leading pharmaceutical firms, Sun Pharma produces pregabalin on a large scale, particularly in Asia, with strict adherence to local and international GMP guidelines.

• Hetero Drugs Ltd. (India): An established generics manufacturer with significant pregabalin production capacity, Hetero operates facilities approved by regulatory authorities like the US FDA and EMA.

• Aurobindo Pharma (India): With a robust portfolio including pregabalin, Aurobindo maintains manufacturing facilities that meet global standards, targeting markets worldwide.

• Cipla Ltd. (India): Cipla produces pregabalin, emphasizing affordable generics for various regions, especially in developing countries.

These companies have obtained necessary approvals from health authorities such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national agencies, ensuring regulatory compliance and quality assurance.

Manufacturing and Quality Standards

Manufacturers of pregabalin adhere to cGMP guidelines to ensure batch-to-batch consistency, safety, and efficacy. Facilities often undergo rigorous inspections by regulatory agencies, with some achieving approvals from multiple authorities, facilitating international trade and supply.

In particular, Indian pharmaceutical manufacturers—such as Sun Pharma, Hetero, and Aurobindo—have substantially increased their presence in the global pregabalin market, owing to their capacity for large-scale production and cost competitiveness [2].

Market Dynamics and Supply Chain Considerations

Patent Expiry and Market Entry

Pregabalin's initial patent protection in various jurisdictions expired around 2018–2020, permitting numerous generics to enter the market. This transition has led to increased competition, price erosion, and diversification of supply sources. However, regulatory hurdles, manufacturing capacity constraints, and IP litigations continue to shape the supply stability.

Supply Chain Risks

Dependence on geographically concentrated manufacturing hubs, especially in India and Israel, introduces risks such as regulatory delays, geopolitical instability, compliance issues, or disruptions due to pandemics. Diversification among multiple suppliers mitigates such risks.

Regulatory and Legal Challenges

Patent litigations and biosimilar disputes occasionally impact generics’ market entry timelines. Companies actively engage in patent challenges or licensing agreements to expedite market access. Regulatory compliance remains paramount for maintaining licenses and avoiding supply interruptions.

Emerging Manufacturers and Future Trends

Research and development efforts focus on biosimilars, alternative formulations, and improved delivery mechanisms. Additionally, new entrants from China and South Korea are expanding manufacturing capacities, aligning with global healthcare demands.

The increasing importance of secure supply chains, digital manufacturing tracking, and compliance with international standards will influence future supplier dynamics. Notably, governmental initiatives and trade policies, such as India’s "Make in India" and the U.S. Drug Supply Chain Security Act, affect sourcing strategies and supply resilience.

Conclusion

The pregabalin supply chain features a mixture of established multinational pharmaceutical firms, robust Indian generics manufacturers, and emerging players. The transition from patent-protected to generic-dominated markets has broadened supplier options but also necessitates vigilance regarding quality, regulatory compliance, and geopolitical risks. Companies seeking to secure pregabalin supply should prioritize partnerships with approved, compliant manufacturers capable of scalable production, ensuring uninterrupted access to this vital medication.

Key Takeaways

• Diversify Suppliers: Engage with multiple approved manufacturers—particularly Indian firms like Sun Pharma, Aurobindo, and Hetero—to mitigate supply risks.
• Monitor Patent and Regulatory Developments: Patents have expired or are expiring; stay updated on legal statuses and approval pathways.
• Ensure Quality and Compliance: Prioritize suppliers with validated manufacturing facilities sanctioned by global regulators like the FDA and EMA.
• Assess Supply Chain Risks: Geographic concentration and regulatory delays pose risks; diversification and contingency planning are essential.
• Stay Ahead of Market Trends: Emerging manufacturers and technological advances may influence future supply dynamics and pricing.

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FAQs

1. Who are the leading manufacturers of pregabalin globally?
The primary manufacturers include Pfizer (branded formulations), along with top generic producers like Teva, Mylan (Viatris), Sun Pharma, Hetero, Aurobindo, and Cipla.

2. How does patent expiration affect pregabalin supply?
Patent expiration has facilitated increased entry of generic manufacturers, expanding supply options and lowering costs, but also requiring vigilance regarding quality and regulatory compliance.

3. Are Indian pharmaceutical companies reliable suppliers for pregabalin?
Yes. Indian firms such as Sun Pharma, Hetero, and Aurobindo are GxP compliant, FDA- and EMA- approved, and possess extensive manufacturing capacity, making them reliable global suppliers.

4. What are the major risks associated with pregabalin supply chains?
Risks include regulatory delays, geopolitical tensions, manufacturing disruptions, quality compliance issues, and patent litigations.

5. What is the outlook for pregabalin supply in the next decade?
The market will likely see increased competition from emerging manufacturers, technological innovation in formulations, and heightened focus on supply chain resilience, ensuring stable access when managed effectively.

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References

[1] Teva Pharmaceutical Industries Ltd. Corporate Reports. (2022).
[2] Indian Pharmaceutical Industry Reports. (2023).