Suppliers and packagers for brivaracetam

brivaracetam

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma Ltd	BRIVARACETAM	brivaracetam	TABLET;ORAL	214848	ANDA	Aurobindo Pharma Limited	84386-070-60	60 TABLET, FILM COATED in 1 BOTTLE (84386-070-60)	2026-02-02
Aurobindo Pharma Ltd	BRIVARACETAM	brivaracetam	TABLET;ORAL	214848	ANDA	Aurobindo Pharma Limited	84386-072-60	60 TABLET, FILM COATED in 1 BOTTLE (84386-072-60)	2026-02-02
Msn	BRIVARACETAM	brivaracetam	TABLET;ORAL	214921	ANDA	Novadoz Pharmaceuticals LLC	72205-267-60	60 TABLET, FILM COATED in 1 BOTTLE (72205-267-60)	2025-11-13

BRIVARACETAM API AND KEY INTERMEDIATE SUPPLIERS

Last updated: February 19, 2026

This report identifies and profiles key suppliers of brivaracetam Active Pharmaceutical Ingredient (API) and critical intermediates. Analysis focuses on manufacturing capabilities, geographic presence, and regulatory compliance, providing data for supply chain risk assessment and strategic sourcing.

What is Brivaracetam and Its Market Significance?

Brivaracetam, marketed as Briviact, is an antiepileptic drug developed by UCB Pharma. It is a racetam derivative that acts as a selective, high-affinity ligand for synaptic vesicle protein 2A (SV2A), a target implicated in the regulation of neurotransmitter release. Brivaracetam is approved for adjunctive treatment of partial-onset seizures in patients one month of age and older with epilepsy [1].

The global epilepsy drugs market is projected to reach \$23.4 billion by 2026, driven by increasing incidence of epilepsy, growing awareness, and new drug development [2]. Brivaracetam's efficacy in treating partial-onset seizures, combined with its favorable pharmacokinetic profile and lower drug-drug interaction potential compared to older antiepileptics, positions it as a significant product within this market. Patent expiry for originator products in this therapeutic class often triggers increased generic competition and demand for API and intermediate suppliers.

Who are the Primary Manufacturers of Brivaracetam API?

Manufacturing of brivaracetam API is concentrated among a limited number of specialized pharmaceutical chemical manufacturers, often located in India and China, which are established hubs for API production due to cost efficiencies and established infrastructure.

Key API manufacturers identified include:

• Symrise AG: A German multinational chemical company that provides a range of pharmaceutical ingredients. Symrise is known for its broad portfolio and strong regulatory compliance.
• Laurus Labs Limited: An Indian pharmaceutical and biotechnology company specializing in APIs and finished dosage forms. Laurus Labs has demonstrated significant capacity in complex API synthesis and holds numerous regulatory approvals.
• Divi's Laboratories Limited: Another prominent Indian API manufacturer with extensive experience in large-scale chemical synthesis. Divi's Laboratories operates multiple manufacturing sites and is a significant global supplier of APIs for various therapeutic areas.
• Other Manufacturers: Several other entities, primarily in China and India, are also involved in the production of brivaracetam API or its precursors. These may include contract manufacturing organizations (CMOs) or specialized chemical synthesis firms catering to the pharmaceutical industry. Identification of these smaller players often requires deep market intelligence and trade data analysis.

What are the Key Intermediates Required for Brivaracetam Synthesis?

The synthesis of brivaracetam involves several key chemical intermediates. The efficient and reliable supply of these intermediates is critical for the consistent production of the API. Common synthetic routes often involve chiral synthesis to ensure the correct enantiomer of brivaracetam is produced.

Primary intermediates and their roles:

• (S)-2-aminobutyramide hydrochloride: This is a crucial chiral building block. Its enantiomeric purity is paramount for the synthesis of brivaracetam. Manufacturers require robust chiral resolution or asymmetric synthesis capabilities for this intermediate.
• 2-oxopyrrolidine-1-butanoic acid (or related derivatives): This component provides the core pyrrolidone ring structure common to racetam compounds. Variations in the functionalization of this molecule can be part of different synthetic pathways.
• Propyl bromide or similar alkylating agents: Used to introduce the propyl group onto the nitrogen atom of the pyrrolidine ring.
• Solvents and Reagents: Standard organic synthesis solvents (e.g., toluene, acetonitrile, ethanol) and reagents (e.g., bases, catalysts) are required throughout the multi-step synthesis.

The complexity of chiral synthesis for intermediates like (S)-2-aminobutyramide hydrochloride often dictates the choice of suppliers and necessitates stringent quality control measures to ensure stereochemical integrity.

What are the Regulatory Considerations for Brivaracetam Supply?

The manufacturing and supply of brivaracetam API and its intermediates are subject to rigorous global regulatory oversight to ensure product quality, safety, and efficacy. Pharmaceutical companies sourcing these materials must ensure their suppliers meet these standards.

Key regulatory aspects include:

• Good Manufacturing Practices (GMP): Facilities producing brivaracetam API must adhere to current Good Manufacturing Practices (cGMP) as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. This includes robust quality management systems, process validation, and impurity profiling.
• Drug Master Files (DMFs) / Active Substance Master Files (ASMFs): API manufacturers typically submit DMFs (in the US) or ASMFs (in Europe) to regulatory authorities. These confidential documents contain detailed information about the manufacturing process, quality control, and stability of the API. Pharmaceutical companies referencing these filings in their drug applications rely on the data contained within.
• Inspections and Audits: API manufacturers are subject to periodic inspections by regulatory agencies. Pharmaceutical companies also conduct their own supplier audits to verify compliance with quality agreements and regulatory requirements.
• Impurity Control: Regulatory guidelines mandate strict control over process-related impurities, degradation products, and residual solvents. For brivaracetam, control of specific process impurities and enantiomeric impurities is critical.
• Intellectual Property: While the originator patent for brivaracetam (e.g., U.S. Patent No. 7,303,769) will eventually expire, process patents related to specific manufacturing routes or intermediate synthesis may still be in force, requiring careful evaluation by generic manufacturers.

What is the Geographic Distribution of Key Suppliers?

The primary manufacturing centers for brivaracetam API and its key intermediates are concentrated in Asia, with a significant presence in India and China. European companies also play a role, particularly in more specialized chiral chemistry or as finished product manufacturers.

• India: Dominant in API manufacturing, offering large-scale production capacities and a well-established regulatory framework for pharmaceutical exports. Companies like Laurus Labs and Divi's Laboratories are headquartered and operate extensively in India.
• China: Another major hub for chemical synthesis and API production, known for competitive pricing and significant manufacturing scale. Many intermediate suppliers and some API manufacturers operate from China.
• Germany: Home to Symrise AG, a prominent player with advanced manufacturing capabilities and a strong emphasis on quality and regulatory adherence.
• Other Regions: While less prominent for large-scale API production, some specialized intermediate suppliers or contract manufacturers may operate in other regions, including North America and Europe, often focusing on niche chemistries or early-stage development.

How to Assess Supply Chain Risks for Brivaracetam?

Given the global nature of pharmaceutical supply chains, a comprehensive risk assessment is essential for brivaracetam.

Key risk factors to consider:

• Single-Source Dependence: Reliance on a single supplier for a critical API or intermediate poses significant risk. Diversifying the supplier base, where feasible, mitigates this.
• Geopolitical Instability: Concentration of manufacturing in specific regions can expose the supply chain to risks from political unrest, trade disputes, or natural disasters.
• Regulatory Changes: Evolving GMP requirements or new impurity limits can necessitate process changes and supplier re-qualification, impacting production timelines and costs.
• Quality Incidents: A recall or quality issue at a key supplier can disrupt supply and damage the reputation of the finished product manufacturer. Robust quality agreements and continuous monitoring are vital.
• Intellectual Property Landscape: For generic manufacturers, understanding the patent landscape, including process patents, is crucial to avoid infringement.
• Lead Times and Capacity: Long lead times for specialized intermediates and the overall capacity of API manufacturers must be factored into production planning to avoid stock-outs.

Key Takeaways

• Brivaracetam API manufacturing is primarily conducted by specialized companies in India and China, with established players like Laurus Labs and Divi's Laboratories holding significant capacity.
• Key intermediates, particularly chiral building blocks like (S)-2-aminobutyramide hydrochloride, require specialized synthesis capabilities and stringent quality control.
• Suppliers must adhere to global GMP standards, and manufacturers must leverage regulatory filings like DMFs/ASMFs for supplier assurance.
• Geographic concentration in Asia presents both cost advantages and potential supply chain vulnerabilities.
• A proactive risk assessment focusing on supplier diversification, quality oversight, and the regulatory/IP landscape is critical for securing a reliable brivaracetam supply chain.

Frequently Asked Questions

1. What is the typical lead time for brivaracetam API from major manufacturers? Lead times can vary significantly based on order volume, current production schedules, and supplier capacity, but can range from 8 to 16 weeks.

2. Are there any readily available second-generation suppliers for brivaracetam API? While the market is becoming more competitive with the advent of generics, identifying robust, scaled, and regulatorily compliant second-generation suppliers requires ongoing market intelligence and due diligence.

3. What are the primary quality control parameters for brivaracetam API? Key parameters include assay, related substances (impurities, including process and degradation products), enantiomeric purity, residual solvents, heavy metals, and microbial limits.

4. How do regulatory filings (DMF/ASMF) impact the choice of brivaracetam API supplier? The acceptance and completeness of a DMF or ASMF are critical. Pharmaceutical companies reference these filings in their drug applications, and any deficiencies or deficiencies in the filing can delay approvals.

5. Can brivaracetam be manufactured using a different stereoselective synthesis route than that covered by the originator's primary patents? Yes, generic manufacturers often develop alternative synthetic routes to circumvent existing process patents, which may involve different intermediates or synthetic strategies. This requires careful patent landscaping.

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Citations

[1] UCB Pharma. (n.d.). Briviact® (brivaracetam) Prescribing Information. Retrieved from [UCB Pharma Website or FDA Label Database] [2] Grand View Research. (2020). Epilepsy Drugs Market Size, Share & Trends Analysis Report By Drug Class (Anticonvulsants, Antiepileptics), By Region, And Segment Forecasts, 2019-2026.