Suppliers and packagers for SABRIL

SABRIL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lundbeck Pharms Llc	SABRIL	vigabatrin	FOR SOLUTION;ORAL	022006	NDA	Lundbeck Pharmaceuticals LLC	67386-211-65	50 PACKET in 1 CARTON (67386-211-65) / 10 mL in 1 PACKET	2009-08-21
Lundbeck Pharms Llc	SABRIL	vigabatrin	TABLET;ORAL	020427	NDA	Lundbeck Pharmaceuticals LLC	67386-111-01	100 TABLET, FILM COATED in 1 BOTTLE (67386-111-01)	2009-08-21

Suppliers for the Pharmaceutical Drug: SABRIL

Last updated: July 31, 2025

Introduction

SABRIL (vigabatrin) is an antiepileptic medication primarily prescribed for the treatment of complex partial seizures and infantile spasms. Approved by the U.S. Food and Drug Administration (FDA) in 2009, SABRIL originates from the anticonvulsant class and is marketed as a branded drug. Its unique mechanism involves irreversible inhibition of gamma-aminobutyric acid (GABA) transaminase, leading to elevated GABA levels in the brain. Given its specialized use and limited manufacturers, understanding the supplier landscape for SABRIL is critical for stakeholders involved in manufacturing, procurement, and distribution.

Market Landscape and Regulatory Context

SABRIL’s market landscape is characterized by its initial exclusivity granted to its patent holder, with subsequent market entries primarily driven by generic manufacturers post-patent expiry. As of recent years, the drug’s patent protections have been phased out or challenged, resulting in increased supplier diversity. Regulatory agencies such as the FDA and European Medicines Agency (EMA) oversee manufacturing standards, ensuring suppliers adhere to Good Manufacturing Practices (GMP).

Original Manufacturer and Patents

Wyeth, a pioneer in SABRIL’s development, originally held the patent and marketed the drug globally. Following Pfizer's acquisition of Wyeth in 2009, Pfizer became the primary supplier and marketer in key markets, including North America. Pfizer's role remains significant, especially in the United States, where SABRIL is approved and available as a branded product.

Generic Manufacturers

The expiration of patent rights opened the market to numerous generic manufacturers. These companies produce bioequivalent versions of vigabatrin, often at reduced prices, expanding access across developing and developed markets.

Key generic suppliers include:

• Mylan (now part of Viatris): One of the largest generic pharmaceutical companies globally, Mylan has produced vigabatrin generics in various formulations, primarily targeting the North American and European markets.
• Teva Pharmaceutical Industries: As a global leader in generics, Teva supplies vigabatrin in multiple regions, adhering to strict GMP standards and obtaining certifications for bioequivalence.
• Sun Pharmaceutical Industries: This Indian-based company manufactures vigabatrin generics for markets including Asia, Africa, and parts of Europe, leveraging cost advantages and extensive distribution networks.
• Hetero Laboratories: An active manufacturer of vigabatrin, Hetero produces both branded and generic forms, predominantly for Asian markets.
• Cipla: Known for affordable generics, Cipla supplies vigabatrin to markets where affordability is a priority, including Africa and Southeast Asia.

Additional players include Aurobindo Pharma, Torrent Pharmaceuticals, and Alvogen, among others, highlighting a competitive landscape driven by regional manufacturing strengths.

Regional Supplier Dynamics

• United States and Canada: The market is predominantly supplied by Pfizer, with generics from Mylan and Teva providing alternatives post-patent expiry.
• Europe: Multiple generic companies, including Teva and Sun Pharmaceutical, hold approvals for vigabatrin, often regulated by EMA standards.
• Asia and Africa: Indian manufacturers such as Sun Pharma, Aurobindo, and Hetero dominate, offering cost-effective options for local markets and global export.

Regulatory Considerations in Supplier Selection

Supply chain security for SABRIL hinges on adherence to GMP standards, confirmed through inspections by authorities like the FDA and EMA. Suppliers with WHO prequalification are preferred for procurement programs targeting emerging markets. Additionally, manufacturers must comply with international regulations on controlled substances and ophthalmic safety, given the drug's associated risks of visual field defects.

Supply Chain Challenges and Risks

Limited sources, especially in the branded segment, pose risks related to supply shortages and price volatility. The complex manufacturing process of vigabatrin demands specialized synthesis capabilities, which restricts the number of active suppliers. The increasing strictness of regulatory standards can also lead to delays in manufacturing approvals, impacting global supply stability.

Future Outlook

The expiration of patents and increased production by reputable generic manufacturers suggest a more diversified supplier environment for SABRIL. Continued regulatory harmonization and quality assurance practices will further facilitate global access. Strategic partnerships or licensing agreements between brand owners and generics can bolster supply stability and ensure compliance.

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Key Takeaways

• Primary Suppliers: Pfizer (original branded manufacturer), with multiple generic manufacturers including Mylan (Viatris), Teva, Sun Pharma, and Hetero leading current supply.
• Regional Variations: Suppliers are region-specific, with Indian and Southeast Asian firms dominating in emerging markets, and Western companies supplying mature markets.
• Regulatory Standards: Suppliers must conform to GMP and international quality certifications; WHO prequalification enhances credibility for global procurement programs.
• Supply Risks: Limited manufacturing complexity constrains supplier diversity, raising potential supply chain vulnerabilities. Enhanced regulatory scrutiny and patent expiries are fostering increased competition.
• Strategic Implications: Stakeholders should monitor patent statuses, regulatory changes, and regional manufacturing advancements to optimize procurement and minimize supply disruptions.

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FAQs

1. Who are the main suppliers of generic vigabatrin (SABRIL)?
The main generic suppliers include Mylan (Viatris), Teva Pharmaceutical Industries, Sun Pharmaceutical Industries, Hetero Laboratories, and Cipla. These companies produce bioequivalent versions, especially targeting markets outside the U.S. and Europe.

2. How does patent expiry influence the supply landscape of SABRIL?
Patent expiry allows generic manufacturers to produce vigabatrin, increasing supply diversity, reducing prices, and improving access in emerging markets. It also fosters competitive dynamics, encouraging quality improvements and supply stability.

3. What regulatory standards must suppliers meet for SABRIL?
Suppliers must comply with GMP as mandated by authorities like the FDA, EMA, and WHO. Certifications such as WHO prequalification further affirm manufacturing quality, especially for procurement programs in low- and middle-income countries.

4. Are there regional differences in SABRIL supplier availability?
Yes. While Pfizer supplies SABRIL commercially in the U.S., generic manufacturers dominate globally, especially in Asia and Africa. Regional regulatory approvals heavily influence supplier availability.

5. What are the main challenges in maintaining a reliable supply chain for SABRIL?
Limited manufacturing complexity, stringent regulatory standards, and relatively low market volume contribute to supply chain risks. Manufacturing capacity constraints and regional regulatory delays can lead to shortages.

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Sources

1. [1] FDA Drug Approval Database. FDA. (2022).
2. [2] Pfizer Official Website. Pfizer. (2022).
3. [3] European Medicines Agency (EMA). Product Information. (2022).
4. [4] IQVIA Institute. Preparing for the Future of Global Supply Chains. (2021).
5. [5] World Health Organization. WHO Prequalification of Medicines Programme. (2022).