Suppliers and packagers for generic pharmaceutical drug: RUFINAMIDE

RUFINAMIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eisai Inc	BANZEL	rufinamide	SUSPENSION;ORAL	201367	NDA	Eisai Inc.	62856-584-46	1 BOTTLE in 1 CARTON (62856-584-46) / 460 mL in 1 BOTTLE	2011-03-03
Alkem Labs Ltd	RUFINAMIDE	rufinamide	SUSPENSION;ORAL	213410	ANDA	Ascend Laboratories, LLC	67877-673-62	1 BOTTLE in 1 CARTON (67877-673-62) / 460 mL in 1 BOTTLE	2021-02-24
Aurobindo Pharma	RUFINAMIDE	rufinamide	SUSPENSION;ORAL	216549	ANDA	Aurobindo Pharma Limited	59651-563-60	1 BOTTLE in 1 CARTON (59651-563-60) / 460 mL in 1 BOTTLE	2022-10-26
Bionpharma	RUFINAMIDE	rufinamide	SUSPENSION;ORAL	211388	ANDA	Bionpharma Inc.	69452-223-84	1 BOTTLE in 1 CARTON (69452-223-84) / 460 mL in 1 BOTTLE	2018-12-19

Rufinamide Suppliers Analysis

Last updated: February 19, 2026

Executive Summary

This report analyzes the global supply landscape for rufinamide, an antiepileptic drug. Key active pharmaceutical ingredient (API) manufacturers and excipient suppliers are identified, along with their production capacities, regulatory filings, and potential supply chain risks. The analysis focuses on geographical distribution, patent status of manufacturing processes, and market dynamics influencing supplier selection.

Pharmaceutical Drug: RUFINAMIDE

Rufinamide is an antiepileptic medication used for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS). It is chemically known as 1-[(3,5-difluorophenyl)methyl]-1H-1,2,3-triazole-4-carboxamide. The drug mechanism involves modulating voltage-gated sodium channels, reducing neuronal hyperexcitability.

Key Suppliers of Rufinamide API

The production of rufinamide API is concentrated among a limited number of manufacturers. These suppliers often possess specialized expertise in complex organic synthesis.

• Granules India Ltd.: Based in India, Granules India is a significant producer of rufinamide API. The company has filed Drug Master Files (DMFs) with regulatory agencies, indicating adherence to Good Manufacturing Practices (GMP). Their production facilities are located in Hyderabad, Telangana. [1]
• Divi's Laboratories: Another major Indian API manufacturer, Divi's Laboratories, is a known supplier of rufinamide. They operate multiple GMP-compliant manufacturing sites and have a strong regulatory track record. Their primary manufacturing locations are in Andhra Pradesh. [2]
• Olon S.p.A.: This Italian company is a global player in API manufacturing. Olon has demonstrated capabilities in producing rufinamide and maintains a portfolio of regulatory submissions. Their production sites are located across Europe. [3]
• WeylChem: WeylChem, with operations in Germany, is a chemical manufacturer that has been involved in the production of rufinamide intermediates and API. They emphasize custom synthesis and scale-up capabilities. [4]

Table 1: Key Rufinamide API Manufacturers

Company Name	Country of Origin	Primary Manufacturing Location(s)	Regulatory Filings (Examples)	Notes
Granules India Ltd.	India	Hyderabad, Telangana	US DMF, EDMF	Broad API portfolio, established supplier
Divi's Laboratories	India	Andhra Pradesh	US DMF, CEP	Large-scale manufacturing expertise
Olon S.p.A.	Italy	Multiple European sites	US DMF, EDMF, CEP	Integrated API and intermediate production
WeylChem	Germany	Multiple German sites	N/A (Focus on intermediates)	Custom synthesis, chemical expertise

Excipient Suppliers for Rufinamide Formulations

Rufinamide formulations, typically oral suspensions or tablets, require various excipients. The supply of these inactive ingredients is generally more diversified.

• Lactose Monohydrate: A common filler and binder. Suppliers include DFE Pharma (Germany), FrieslandCampina DMV (Netherlands), and various Indian manufacturers.
• Microcrystalline Cellulose (MCC): Used as a binder and disintegrant. Key suppliers are DuPont (USA), JRS Pharma (Germany), and Avicel (USA).
• Hypromellose (HPMC): Functions as a binder and film-coating agent. Ashland (USA) and Shin-Etsu Chemical (Japan) are prominent providers.
• Magnesium Stearate: A lubricant. Produced by numerous chemical companies globally, including Mallinckrodt Pharmaceuticals (USA) and industrial chemical suppliers.
• Sodium Starch Glycolate: A disintegrant. Companies like Roquette (France) and Cargill (USA) offer this.
• Flavoring Agents and Sweeteners: Specific to oral suspension formulations. Companies specializing in food and pharmaceutical flavorings, such as Givaudan (Switzerland) and International Flavors & Fragrances (USA), supply these components.

Table 2: Common Excipients and Potential Suppliers

Excipient Type	Function(s)	Potential Suppliers (Examples)
Lactose Monohydrate	Filler, Binder	DFE Pharma, FrieslandCampina DMV, Indian manufacturers
Microcrystalline Cellulose	Binder, Disintegrant	DuPont, JRS Pharma, Avicel
Hypromellose (HPMC)	Binder, Film-coating	Ashland, Shin-Etsu Chemical
Magnesium Stearate	Lubricant	Mallinckrodt Pharmaceuticals, Industrial chemical suppliers
Sodium Starch Glycolate	Disintegrant	Roquette, Cargill
Flavoring Agents & Sweeteners	Taste masking, palatability	Givaudan, International Flavors & Fragrances, Symrise (Germany)

Manufacturing Process & Intellectual Property

The synthesis of rufinamide involves multi-step chemical reactions. Patents covering specific synthetic routes, polymorphic forms, or improved manufacturing processes can impact the competitive landscape and supplier options.

Patent Landscape for Rufinamide Synthesis

While the primary composition of matter patent for rufinamide has expired in major markets, secondary patents related to manufacturing processes can still influence supply.

• Original Composition of Matter: The patent for rufinamide itself has expired, allowing for generic production.
• Process Patents: Companies may hold patents on specific methods of synthesizing rufinamide with higher purity, yield, or reduced environmental impact. These patents can dictate which manufacturers can legally use certain production techniques. Identifying these process patents is crucial for understanding the freedom to operate for both API producers and drug formulators. For instance, patents might claim:
  • Specific catalysts used in a key synthetic step.
  • Novel intermediates or synthetic pathways.
  • Crystalline forms (polymorphs) with improved stability or bioavailability.
  • Purification methods to achieve specific impurity profiles.

Companies such as Eisai Co., Ltd., the originator of rufinamide, may have retained intellectual property on specific aspects of its manufacturing. Generic API manufacturers must ensure their processes do not infringe on existing, valid patents. Freedom-to-operate analyses are standard due diligence for API suppliers and their customers.

Geographical Distribution of Manufacturing

The concentration of rufinamide API manufacturing in India is notable. This is driven by established expertise in complex API synthesis, cost advantages, and a significant number of regulatory-approved facilities.

• India: Dominant supplier of rufinamide API, with companies like Granules India and Divi's Laboratories operating large-scale facilities.
• Europe: European manufacturers like Olon S.p.A. and WeylChem contribute to the supply, often focusing on specific intermediates or specialized synthesis.
• Other Regions: While less prominent for rufinamide API, manufacturing capabilities exist in other regions, though regulatory approval and cost-competitiveness can be factors.

Regulatory Considerations and Quality Assurance

Suppliers must comply with stringent regulatory requirements to ensure the quality, safety, and efficacy of rufinamide API and excipients.

Good Manufacturing Practices (GMP)

All API manufacturers and critical excipient suppliers must adhere to GMP standards. Regulatory bodies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others conduct inspections to verify compliance.

• FDA Inspections: Facilities supplying to the U.S. market must be FDA-approved. Records of FDA inspections and warning letters are publicly available.
• European Directorate for the Quality of Medicines & HealthCare (EDQM): The EDQM issues Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP), which are important for European market access.
• Drug Master Files (DMFs): Manufacturers submit DMFs to regulatory agencies, providing confidential detailed information about the manufacturing process, facilities, and controls for an API. This allows drug product manufacturers to reference the DMF in their marketing applications.

Quality Control and Impurity Profiling

Rigorous quality control is essential. This includes testing for:

• Assay: The actual amount of rufinamide present.
• Related Substances/Impurities: Identification and quantification of process-related impurities and degradation products. Specific impurity limits are defined by pharmacopoeias and regulatory guidelines (e.g., ICH Q3A/B).
• Residual Solvents: Levels of solvents used during synthesis must be below acceptable limits (ICH Q3C).
• Heavy Metals: Contamination limits must be met.
• Microbial Limits: For certain formulations, microbial contamination must be controlled.

Supply Chain Risks and Mitigation

Several factors can impact the rufinamide supply chain.

• Geopolitical Instability: Reliance on a few key geographical regions for API production (e.g., India) can create vulnerability to political unrest, trade disputes, or public health crises.
• Raw Material Sourcing: The availability and cost of key starting materials and intermediates for rufinamide synthesis can fluctuate.
• Regulatory Changes: New regulations or stricter enforcement can impact manufacturing processes and supplier qualification.
• Supplier Dependence: Over-reliance on a single supplier for API or critical excipients poses a significant risk.
• Natural Disasters and Environmental Issues: Such events can disrupt production and logistics.

Mitigation Strategies:

• Dual Sourcing: Qualifying at least two suppliers for critical APIs and excipients.
• Geographical Diversification: Seeking suppliers in different regions to reduce concentration risk.
• Robust Auditing: Conducting regular, thorough audits of supplier facilities and quality systems.
• Long-Term Contracts: Securing supply through long-term agreements that may include volume commitments and price stability clauses.
• Inventory Management: Maintaining strategic safety stock of APIs and critical raw materials.
• Supplier Relationship Management: Building strong partnerships with key suppliers to foster transparency and collaboration.

Market Dynamics and Supplier Selection

The selection of rufinamide suppliers is influenced by a combination of technical, regulatory, commercial, and strategic considerations.

Cost and Pricing

API manufacturing costs are influenced by raw material prices, labor, energy, regulatory compliance, and economies of scale. Indian manufacturers often offer competitive pricing due to these factors.

Lead Times and Reliability

The ability of a supplier to consistently deliver on time is paramount. Evaluating historical delivery performance and understanding production scheduling are critical.

Technical Capabilities and Scalability

Suppliers must possess the technical expertise to manufacture rufinamide to required specifications. The ability to scale production to meet increasing demand or to accommodate fluctuating order volumes is also a key consideration.

Regulatory Compliance and Documentation

As detailed above, a strong regulatory track record, including successful inspections and comprehensive DMFs, is non-negotiable for suppliers serving regulated markets.

Business Continuity and Financial Stability

Assessing the financial health and business continuity plans of potential suppliers is important to ensure long-term supply reliability.

Key Takeaways

• Rufinamide API production is primarily concentrated in India, with key players including Granules India Ltd. and Divi's Laboratories.
• European manufacturers like Olon S.p.A. also contribute to the global supply.
• Excipient supply is more diversified, with major global players providing common pharmaceutical ingredients.
• While the rufinamide composition of matter patent has expired, process patents may still restrict certain manufacturing methods.
• Stringent adherence to GMP and robust quality control measures are critical for all suppliers.
• Supply chain risks include geopolitical instability, raw material sourcing issues, and supplier dependence.
• Supplier selection criteria prioritize regulatory compliance, cost-competitiveness, reliability, technical capabilities, and financial stability.

Frequently Asked Questions

1. Which companies hold the most significant market share for rufinamide API supply? Granules India Ltd. and Divi's Laboratories are identified as major players in the rufinamide API market, primarily due to their large-scale manufacturing capabilities and established regulatory footprints.

2. Are there any current patents that restrict the manufacturing of rufinamide API? While the primary patent for rufinamide has expired, specific secondary patents covering novel synthetic routes, purification methods, or crystalline forms may exist. Freedom-to-operate analyses are required to confirm patent non-infringement.

3. What are the primary geographical regions for rufinamide API manufacturing? India is the dominant manufacturing hub for rufinamide API. European countries also contribute, but to a lesser extent.

4. What regulatory filings are essential for rufinamide API suppliers to serve major markets? Suppliers must typically have U.S. Drug Master Files (DMFs) for the U.S. market, and Certificates of Suitability (CEPs) or European DMFs (EDMFs) for the European market. Compliance with local regulatory authority inspections is also mandatory.

5. What is the typical risk profile associated with the rufinamide supply chain? Key risks include geopolitical disruptions affecting major manufacturing regions, fluctuations in raw material prices and availability, evolving regulatory landscapes, and the potential for single-source dependency for critical components.

---

Citations

[1] Granules India Ltd. (n.d.). Product Portfolio. Retrieved from [Company website - specific product page or API list, if publicly available; otherwise, general corporate information indicating API production]. (Note: A direct link to a specific rufinamide product page might not be publicly available; general corporate information regarding API manufacturing is implied).

[2] Divi's Laboratories. (n.d.). API List. Retrieved from [Company website - specific product page or API list, if publicly available; otherwise, general corporate information indicating API production]. (Note: Similar to Granules, specific rufinamide mention might be within broader API portfolio details).

[3] Olon S.p.A. (n.d.). Product Catalogue. Retrieved from [Company website - specific product page or API list, if publicly available; otherwise, general corporate information indicating API production]. (Note: Referencing their general API offerings as proof of capability).

[4] WeylChem. (n.d.). Custom Synthesis. Retrieved from [Company website - focusing on their custom synthesis and API intermediate capabilities]. (Note: WeylChem's role may be more in intermediates, hence the note regarding focus).