Suppliers and packagers for lyrica

lyrica

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446	NDA	Parke-Davis Div of Pfizer Inc	0071-1014-41	100 BLISTER PACK in 1 CARTON (0071-1014-41) / 1 CAPSULE in 1 BLISTER PACK	2004-12-30
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446	NDA	Parke-Davis Div of Pfizer Inc	0071-1014-68	90 CAPSULE in 1 BOTTLE (0071-1014-68)	2004-12-30
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446	NDA	Parke-Davis Div of Pfizer Inc	0071-1015-41	100 BLISTER PACK in 1 CARTON (0071-1015-41) / 1 CAPSULE in 1 BLISTER PACK	2004-12-30
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446	NDA	Parke-Davis Div of Pfizer Inc	0071-1015-68	90 CAPSULE in 1 BOTTLE (0071-1015-68)	2004-12-30

Suppliers for the Pharmaceutical Drug: Lyrica

Last updated: July 31, 2025

Introduction

Lyrica, whose generic name is pregabalin, is a widely prescribed medication used primarily for managing neuropathic pain, fibromyalgia, and as an adjunct therapy for partial seizures. Developed and marketed by Pfizer, Lyrica's global demand has driven suppliers and manufacturers across the pharmaceutical supply chain to ensure consistent, high-quality production. Understanding the landscape of suppliers for pregabalin is crucial for stakeholders including pharmaceutical companies, healthcare providers, and regulatory bodies to evaluate supply chain security, compliance, and market dynamics.

Market Overview

Pregabalin was first approved by the FDA in 2004 and has since become a blockbuster drug with substantial revenues. Its essential role in pain management and neurological disorders has led to a complex landscape of suppliers spanning multiple countries, including manufacturing giants in both developed and emerging markets. The global pregabalin market is fiercely competitive, with companies seeking to maintain supply stability amidst regulatory constraints, patent expirations, and manufacturing scalability challenges.

Key Suppliers of Lyrica (Pregabalin)

1. Pfizer Inc. (Originator)

Pfizer holds the original patents and manufacturing rights for Lyrica. Its role as the primary supplier involves large-scale production under strict regulatory standards, including Good Manufacturing Practices (GMP). Pfizer’s global footprint ensures its capacity to meet international demand, but its market exclusivity period has transitioned in some regions to generic formulations following patent expiry.

2. Generic Manufacturers

Post-patent expiration, a surge in generic pregabalin manufacturers emerged, significantly impacting price points and supply chain diversity. Prominent generic suppliers include:

• Cipla Limited (India): As one of India’s largest pharmaceutical companies, Cipla produces pregabalin in multiple dosages, exporting globally. Their manufacturing facilities adhere to stringent quality standards and are licensed by major regulatory agencies including the US FDA.

• Sun Pharmaceutical Industries Ltd. (India): Sun Pharma is another significant player, supplying generic pregabalin formulations across North America, Europe, and Asia. Their manufacturing facilities have been inspected and certified to ensure compliance with international standards.

• Dr. Reddy’s Laboratories (India): Reddy’s offers pregabalin as part of its broader portfolio of generic pharmaceuticals, with supply agreements with various countries. Their manufacturing units are compliant with global standards, securing their role as reliable suppliers.

• Mylan (now part of Viatris): Mylan has historically supplied pregabalin globally, maintaining supply continuity and competing primarily on cost-efficiency.

• Teva Pharmaceutical Industries (Israel): Teva is a major supplier of generic pregabalin in various markets, known for its extensive manufacturing network and global distribution channels.

3. Contract Manufacturing Organizations (CMOs)

Large pharmaceutical firms increasingly rely on CMOs for pregabalin production to cater to surging demand and regional market needs. Notable CMOs include:

• Famar (Greece): Engaged in contract manufacturing of pregabalin at various scales.

• Hetero Labs (India): Provides bulk pregabalin API and finished formulations to global markets under contract agreements.

4. API (Active Pharmaceutical Ingredient) Suppliers

The raw material of pregabalin, the API, is sourced from specialized producers with complex synthesis pathways involving chiral compounds. Leading API producers include:

• Zhejiang Huahong Pharmaceutical Co. (China): Supplies bulk pregabalin API to global manufacturers.

• Hikal Ltd. (India): Offers pregabalin API, meeting international quality standards, and is active in supply chain diversification.

• Alpine Chemical Industry Ltd. (India): Another key API supplier, contributing to diversified supply sources.

5. Regional Distributors

In addition to manufacturers, regional distributors play a vital role in ensuring product availability, especially in emerging markets. They source from primary suppliers and handle logistics, compliance, and local regulatory requirements.

Supply Chain Challenges and Strategies

• Regulatory Compliance: Suppliers must adhere to strict GMP standards, particularly in the US, EU, and Japan, which can impact the diversity of suppliers available for certain markets.

• Patent Expiry Dynamics: Post-patent landscapes have led to an influx of generic players, increasing supply options but also complicating quality assurance and regulatory oversight.

• Manufacturing Scalability: High global demand requires suppliers to scale production rapidly, which can strain existing capacities and prompt strategic partnerships or acquisitions.

• Supply Security: To mitigate risks of supply disruptions, companies often source from multiple suppliers across different geographical regions and maintain safety stock levels.

Implications for Stakeholders

• Pharmaceutical Companies: Need to develop robust supply chain strategies, including diversified sourcing, to prevent shortages.

• Regulators: Must monitor API and finished product manufacturing standards across suppliers to ensure safety and quality.

• Healthcare Providers: Should be aware of possible variability in generics' supply, especially during regional shortages.

• Investors: Monitoring supplier stability and regulatory compliance offers insight into market competitiveness and potential opportunities.

Conclusion

Lyrica’s global supply landscape exemplifies the importance of a diversified supplier base, regulatory adherence, and strategic manufacturing partnerships. While Pfizer retains the original production rights, the proliferation of high-quality generic manufacturers, API suppliers, and CMOs has expanded the supply chain, facilitating widespread access. Continuous monitoring of regulatory changes, patent statuses, and market demands will be essential for stakeholders to maintain a resilient and compliant supply chain for pregabalin.

Key Takeaways

• The original patent-holder, Pfizer, remains a pivotal supplier, but the market is driven by numerous high-quality generic manufacturers, predominantly in India, China, and Israel.

• API suppliers such as Zhejiang Huahong and Hikal are crucial to ensure supply continuity and quality.

• Regulatory compliance and quality assurance are foremost considerations, with GMP standards serving as benchmark criteria for all suppliers.

• Supply chain diversification reduces vulnerability to regional disruptions and patent cliffs.

• Strategic partnerships with CMOs and API producers bolster scalability and responsiveness to market demands.

FAQs

1. Who are the primary manufacturers of pregabalin globally?
Major manufacturers include Pfizer (original), Cipla, Sun Pharma, Dr. Reddy’s, Mylan (Viatris), and Teva, along with numerous API suppliers like Zhejiang Huahong and Hikal.

2. How has patent expiration impacted the pregabalin supply chain?
It led to a surge in generic manufacturers, increasing supply options, reducing prices, and necessitating increased focus on quality assurance and regulatory compliance across multiple suppliers.

3. What regions are the largest sources of pregabalin supply?
India and China dominate API and generic drug manufacturing, with regional distributors facilitating access in North America, Europe, and emerging markets.

4. How do regulatory standards influence supplier selection?
Compliance with GMP, FDA, EMA, and other authorities ensures safety and quality, often dictating supplier suitability, especially in strict markets like the US and EU.

5. What are the risks associated with pregabalin supply chain disruptions?
Risks include regulatory non-compliance, manufacturing delays, geopolitical issues, and raw material shortages, all of which can impact drug availability and pricing.

---

Sources:
[1] Pfizer, "Lyrica (pregabalin) Prescribing Information," 2022.
[2] European Medicines Agency, "Pregabalin Summary of Product Characteristics," 2023.
[3] Indian Pharmaceutical Industry Reports, 2022.
[4] U.S. FDA, "Approved Drug Products with Therapeutic Equivalence Evaluations," 2023.
[5] GlobalData Pharma Intelligence, "Pregabalin Market Analysis," 2022.