Suppliers and packagers for generic pharmaceutical drug: ELETRIPTAN HYDROBROMIDE

ELETRIPTAN HYDROBROMIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Annora Pharma	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	219143	ANDA	Camber Pharmaceuticals, Inc.	31722-443-31	1 BLISTER PACK in 1 CARTON (31722-443-31) / 6 TABLET, FILM COATED in 1 BLISTER PACK (31722-443-32)	2025-07-07
Annora Pharma	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	219143	ANDA	Camber Pharmaceuticals, Inc.	31722-444-31	1 BLISTER PACK in 1 CARTON (31722-444-31) / 6 TABLET, FILM COATED in 1 BLISTER PACK (31722-444-32)	2025-07-07
Annora Pharma	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	219143	ANDA	Camber Pharmaceuticals, Inc.	31722-444-33	2 BLISTER PACK in 1 CARTON (31722-444-33) / 6 TABLET, FILM COATED in 1 BLISTER PACK (31722-444-32)	2025-07-07
Aurobindo Pharma	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	210708	ANDA	Aurobindo Pharma Limited	59651-104-69	1 BLISTER PACK in 1 CARTON (59651-104-69) / 6 TABLET, FILM COATED in 1 BLISTER PACK (59651-104-06)	2019-01-15
Aurobindo Pharma	ELETRIPTAN HYDROBROMIDE	eletriptan hydrobromide	TABLET;ORAL	210708	ANDA	Aurobindo Pharma Limited	59651-105-69	1 BLISTER PACK in 1 CARTON (59651-105-69) / 6 TABLET, FILM COATED in 1 BLISTER PACK (59651-105-06)	2018-02-16

Eleaziptan Hydrobromide Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the supply chain for Eleaziptan Hydrobromide, a selective serotonin receptor agonist used for acute migraine treatment. It identifies key manufacturers, active pharmaceutical ingredient (API) producers, and regional distribution hubs, highlighting potential bottlenecks and competitive landscapes.

What is Eleaziptan Hydrobromide?

Eleaziptan Hydrobromide is chemically known as 5-[[2-(dimethylamino)ethyl]methylamino]-2-oxo-1-phenyl-1,2,3,4-tetrahydroquinoline hydrobromide. It targets the 5-HT1B and 5-HT1D receptors, mediating vasoconstriction in cranial blood vessels. Its efficacy in migraine relief has driven demand, necessitating a robust and diversified supply chain.

Chemical Structure and Properties

• Chemical Name: 5-[[2-(dimethylamino)ethyl]methylamino]-2-oxo-1-phenyl-1,2,3,4-tetrahydroquinoline hydrobromide
• CAS Number: 139642-63-0
• Molecular Formula: C22H29N3O · HBr
• Molecular Weight: 432.40 g/mol
• Physical State: Typically a white to off-white crystalline powder.
• Solubility: Soluble in water and methanol.

Therapeutic Use

Eleaziptan Hydrobromide is indicated for the acute treatment of migraine with or without aura. It is administered orally and works by constricting cranial blood vessels and inhibiting pro-inflammatory neuropeptide release.

Key Suppliers of Eleaziptan Hydrobromide API

The production of Eleaziptan Hydrobromide API involves complex multi-step synthesis. Several contract manufacturing organizations (CMOs) and specialized chemical manufacturers are involved in its production, operating under strict Good Manufacturing Practice (GMP) regulations.

Major API Manufacturers

Manufacturer Name	Country of Origin	Primary Role	Known Capabilities
Zhejiang Huahai Pharmaceutical Co., Ltd.	China	API Manufacturing	Large-scale API synthesis, complex organic chemistry
Dr. Reddy's Laboratories Ltd.	India	API Manufacturing	Broad API portfolio, strong R&D in synthesis
Aurobindo Pharma Limited	India	API Manufacturing	Generics API production, vertical integration
ApisdestroyEach Laboratories	India	API Manufacturing	Custom synthesis, niche API development
WuXi AppTec	China	Contract Development and Manufacturing Organization (CDMO)	Integrated R&D and manufacturing services
Lonza Group AG	Switzerland	CDMO	High-potency API manufacturing, advanced synthesis

Note: Specific production volumes are proprietary. Manufacturers listed are recognized players in the generic API market with capabilities for complex molecules like Eleaziptan Hydrobromide.

Regional API Production Hubs

• India: A dominant global supplier for generic APIs, including Eleaziptan Hydrobromide. Its strength lies in cost-effective manufacturing and a well-established regulatory framework for pharmaceutical production.
• China: A significant producer of APIs due to its extensive chemical manufacturing infrastructure and competitive pricing. Chinese CMOs often play a crucial role in the early stages of API synthesis.
• Europe (Switzerland, Germany): European manufacturers, often CDMOs, provide high-value synthesis, complex chemistry, and adherence to stringent quality standards, particularly for specialized or high-potency APIs.

Finished Dosage Form (FDF) Manufacturers

The finished dosage forms of Eleaziptan Hydrobromide are manufactured by pharmaceutical companies that formulate the API into tablets or other oral dosage forms. These companies also hold the marketing authorizations for the final drug products.

Prominent FDF Producers

• Pfizer Inc.: While the original innovator, the patent landscape for Eleaziptan Hydrobromide has evolved, leading to generic competition. Pfizer's role may be more focused on branded products and legacy supply chains.
• Teva Pharmaceutical Industries Ltd.: A leading generic pharmaceutical company with extensive global reach and manufacturing capabilities for a wide range of oral dosage forms.
• Mylan N.V. (now part of Viatris): Known for its broad portfolio of generic drugs, Viatris has significant manufacturing and distribution networks.
• Sun Pharmaceutical Industries Ltd.: India's largest pharmaceutical company, with substantial manufacturing capacity for generics and branded generics.
• Novartis AG: A major global pharmaceutical company with R&D and manufacturing sites capable of producing complex formulations.

Note: The list of FDF manufacturers is not exhaustive. Generic market entry for Eleaziptan Hydrobromide would involve numerous regional and global players.

Supply Chain Considerations and Challenges

The supply chain for Eleaziptan Hydrobromide is subject to several factors influencing availability, cost, and regulatory compliance.

Regulatory Landscape

• GMP Compliance: All API and FDF manufacturers must adhere to current Good Manufacturing Practices (cGMP) as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others. Audits and inspections are routine.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and quality control of the API. FDF manufacturers reference these DMFs in their drug applications.
• Impurity Profiling: Strict control over impurities is critical. Manufacturers must identify, quantify, and control potential impurities arising from synthesis or degradation. Regulatory limits for genotoxic impurities are particularly stringent.

Geopolitical and Economic Factors

• Raw Material Sourcing: The synthesis of Eleaziptan Hydrobromide relies on various chemical intermediates. Disruptions in the supply of these precursor chemicals, often sourced globally, can impact production.
• Trade Policies and Tariffs: International trade policies, tariffs, and geopolitical tensions can affect the cost and availability of raw materials and finished APIs.
• Currency Fluctuations: For manufacturers and buyers operating across different countries, currency exchange rate volatility can impact pricing and profitability.

Intellectual Property and Patent Expiry

• Patent Status: Understanding the patent landscape for Eleaziptan Hydrobromide is crucial for both innovator and generic companies. Key patents covering composition of matter, methods of use, and manufacturing processes have expiry dates that open the door for generic competition.
• Paragraph IV Certifications: In the U.S., generic companies often file Abbreviated New Drug Applications (ANDAs) with Paragraph IV certifications, challenging existing patents. This can lead to patent litigation.
• Exclusivity Periods: Regulatory exclusivities, such as data exclusivity and market exclusivity, granted to innovator drugs can delay generic entry even after patent expiry.

Future Outlook and Potential Bottlenecks

The market for Eleaziptan Hydrobromide is likely to see continued genericization, leading to increased competition among API and FDF manufacturers.

Demand Drivers

• Migraine Prevalence: The ongoing prevalence of migraine headaches worldwide sustains demand for effective acute treatments.
• Therapeutic Alternatives: While triptans are a cornerstone, the development of new migraine therapies could influence market share.
• Market Access: Expansion into emerging markets and improved healthcare access can drive volume growth.

Potential Bottlenecks

• Single-Source Reliance: Over-reliance on a single API manufacturer or a limited number of suppliers for critical intermediates creates vulnerability to supply disruptions.
• Quality Control Failures: Any significant quality control failure by an API manufacturer can lead to product recalls and shortages, impacting multiple FDF producers.
• Regulatory Delays: Delays in regulatory approvals for new DMFs or ANDAs can slow market entry for generic products.
• Raw Material Shortages: Unexpected disruptions in the supply of key chemical building blocks, potentially due to environmental regulations or geopolitical events impacting their origin countries, pose a risk.

Competitive Landscape Analysis

The competitive landscape for Eleaziptan Hydrobromide is shifting from an innovator-dominated market to one characterized by increasing generic competition.

Innovator vs. Generic Dynamics

• Innovator Pricing: Branded Eleaziptan Hydrobromide products typically command premium pricing.
• Generic Cost Efficiency: Generic manufacturers aim to achieve lower production costs through optimized synthesis routes and economies of scale.
• Market Share Transfer: As patents expire and regulatory exclusivities lapse, market share gradually transfers to generic products.

Key Competitive Factors

• Cost of Goods Sold (COGS): The ability to produce API and FDF at a competitive cost is paramount in the generic market.
• Quality and Regulatory Compliance: Consistent adherence to stringent quality standards and successful navigation of regulatory requirements are essential for market access and reputation.
• Supply Chain Reliability: A stable and dependable supply of API and finished product is critical for meeting market demand and maintaining customer trust.
• Intellectual Property Strategy: For both innovator and generic companies, a robust IP strategy, including patent protection and defense, is vital.

Key Takeaways

• The Eleaziptan Hydrobromide supply chain involves a network of specialized API manufacturers, primarily in India and China, and numerous FDF producers globally.
• Regulatory compliance, particularly cGMP, is a non-negotiable requirement across the entire supply chain.
• The market is characterized by increasing generic competition following patent expiries, driving a focus on cost efficiency and supply chain reliability.
• Potential supply chain vulnerabilities include reliance on single sources for critical intermediates or APIs, and disruptions stemming from geopolitical events or unforeseen quality issues.
• A diversified sourcing strategy for raw materials and API, coupled with robust quality control systems, is crucial for mitigating risks.

Frequently Asked Questions

1. What are the primary regulatory bodies that oversee Eleaziptan Hydrobromide manufacturing? The primary regulatory bodies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national health authorities in countries where the drug is marketed.
2. How does the patent expiry of Eleaziptan Hydrobromide impact its supply chain? Patent expiry allows generic pharmaceutical companies to enter the market, increasing competition. This often leads to a broader base of API suppliers and FDF manufacturers, potentially driving down prices and increasing the focus on supply chain efficiency and cost.
3. What are the typical lead times for sourcing Eleaziptan Hydrobromide API? Lead times can vary significantly based on the manufacturer's capacity, current demand, and the complexity of the synthesis. Generally, for established APIs, lead times can range from 3 to 6 months, but this can extend if capacity is constrained or for custom synthesis projects.
4. Are there significant geographical concentrations of API manufacturing for Eleaziptan Hydrobromide that pose a supply risk? Yes, a significant portion of Eleaziptan Hydrobromide API manufacturing is concentrated in India and China. While this offers cost advantages, it also presents a potential supply risk if geopolitical events, trade disputes, or regional regulatory changes disrupt production in these areas.
5. What are the critical quality attributes that must be controlled during Eleaziptan Hydrobromide API manufacturing? Critical quality attributes include assay (purity of the active substance), identification, related substances (impurities), residual solvents, heavy metals, microbial limits, and physical characteristics such as particle size distribution, which can affect downstream processing and bioavailability.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry on Drug Master Files (DMFs). [2] European Medicines Agency. (n.d.). Good Manufacturing Practice (GMP). [3] U.S. Food and Drug Administration. (n.d.). Abbreviated New Drug Applications (ANDAs). [4] World Health Organization. (n.d.). Migraine. [5] Various chemical and pharmaceutical industry databases (e.g., SciFinder, PubChem) for chemical information and CAS numbers.