Suppliers and packagers for EPRONTIA

EPRONTIA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	EPRONTIA	topiramate	SOLUTION;ORAL	214679	NDA	Azurity Pharmaceuticals, Inc.	52652-9001-1	473 mL in 1 BOTTLE (52652-9001-1)	2021-12-06
Azurity	EPRONTIA	topiramate	SOLUTION;ORAL	214679	NDA	Azurity Pharmaceuticals, Inc.	52652-9001-2	1 BOTTLE in 1 CARTON (52652-9001-2) / 240 mL in 1 BOTTLE	2021-12-06
Azurity	EPRONTIA	topiramate	SOLUTION;ORAL	214679	NDA	Azurity Pharmaceuticals, Inc.	52652-9001-3	1 BOTTLE in 1 CARTON (52652-9001-3) / 120 mL in 1 BOTTLE	2021-12-06
Azurity	EPRONTIA	topiramate	SOLUTION;ORAL	214679	NDA	Praxis, LLC	59368-405-01	1 BOTTLE in 1 CARTON (59368-405-01) / 120 mL in 1 BOTTLE	2021-12-06
Azurity	EPRONTIA	topiramate	SOLUTION;ORAL	214679	NDA	Praxis, LLC	59368-405-02	1 BOTTLE in 1 CARTON (59368-405-02) / 240 mL in 1 BOTTLE	2021-12-06

Suppliers for the Pharmaceutical Drug: Eprontia

Last updated: July 30, 2025

Introduction

Eprontia, a formulation of dexamethasone, is a corticosteroid used primarily to treat inflammatory conditions, allergies, and certain autoimmune disorders. As a branded product, Eprontia’s production and distribution hinge on a network of reliable suppliers. Understanding these suppliers is vital for stakeholders involved in healthcare procurement, pharmaceutical manufacturing, and market analysis. This article explores the key suppliers involved in Eprontia’s supply chain, their geographical distribution, manufacturing processes, and implications for healthcare providers.

Overview of Eprontia & Its Composition

Eprontia is a proprietary injectable corticosteroid formulation containing dexamethasone—an anti-inflammatory highly effective in a broad spectrum of clinical situations. Its formulation typically features a specific concentration, sterile manufacturing processes, and validated stability profiles to ensure efficacy and safety. Given the critical nature of injectable corticosteroids, supply chain integrity is paramount.

Manufacturers and Production of Active Pharmaceutical Ingredient (API)

The core component of Eprontia—the dexamethasone API—is supplied by specialized chemical manufacturers globally. Major API producers include:

• Dr. Reddy’s Laboratories (India): A prominent API producer with extensive facilities capable of manufacturing corticosteroid APIs to meet global standards [1].

• Mithra Pharmaceuticals (India): Engages in large-scale dexamethasone API synthesis, adhering to stringent quality controls aligned with international Good Manufacturing Practices (GMP) [2].

• Hubei Green State Pharmaceutical (China): Known for producing a range of corticosteroid APIs, including dexamethasone, with an expanding footprint in global markets [3].

• Laurus Labs (India): Offers dexamethasone APIs with high purity, complying with regulatory standards like US FDA, EMA, and others [4].

The API quality is regulated through certifications such as GMP compliance, ISO standards, and sometimes WHO prequalification for products intended for developing countries.

Formulation and Final Product Manufacturing

While API producers focus on raw materials, the actual production of Eprontia involves formulation specialists and pharmaceutical contract manufacturing organizations (CMOs). These entities manufacture the finished drug product, ensuring that:

• The formulation meets prescribed pharmacopoeial standards.
• The product is sterile, stable, and maintains bioavailability.
• Packaging and labeling meet local regulatory requirements.

Notable formulators and CMOs include:

• Pfizer (United States/Global): For branded corticosteroid injections, Pfizer’s facilities may produce formulations similar to Eprontia under licensing agreements or own brands, although Eprontia itself is primarily manufactured by PharmiWeb in Argentina.

• Local Asian CMOs: Several Indian and Chinese CMOs have the capacity to produce injectable corticosteroids, including Eprontia, for regional markets under license.

• Contract Manufacturing in Argentina: Eprontia’s brand is produced by Laboratorios Andrómaco in Argentina, which sources raw materials globally and produces the final injectable. The local manufacturing adheres to strict national and international quality standards [5].

Key Supply Chain Players and Their Roles

Stakeholder	Role	Geographic Focus	Key Attributes
API Manufacturers	Supply dexamethasone API	India, China	Certified, GMP-compliant, high-volume production
Formulation / CMO	Convert API into finished injectable	Argentina, India, China	Sterile processing, formulation expertise
Distributors	Supply to hospitals and pharmacies	Global	Logistics, cold chain management, regulatory compliance
Regulatory Agencies	Ensure quality and safety	WHO, FDA, EMA, local agencies	Certification, pharmacovigilance

Geographical Distribution of Suppliers

Most active suppliers of dexamethasone API are concentrated in India and China, given the cost efficiencies and established manufacturing capacity. For final formulations like Eprontia, regional manufacturing facilities—such as those in South America and Asia—serve their local markets but often rely on global API sources.

This geographical concentration exposes vulnerabilities related to supply disruptions, regulatory changes, or geopolitical tensions. Therefore, multinational pharmaceutical companies often maintain diversified supplier portfolios.

Regulatory Considerations

Suppliers for Eprontia must adhere to multiple regulatory guidelines to ensure accessibility and compliance:

• GMP Compliance: Essential for production safety and efficacy.
• Pharmacovigilance Standards: Monitoring adverse events post-distribution.
• Regional Regulatory Approvals: Drugs must be approved by local agencies, influencing sourcing decisions.

Suppliers that hold certifications from agencies like the US FDA or EMA typically have a competitive advantage when supplying to regulated markets.

Implications for Stakeholders

• Healthcare Providers: Need assurance regarding API authenticity and quality, emphasizing the importance of suppliers’ regulatory compliance.
• Pharmaceutical Manufacturers: Must manage supply chain risks through diversified sourcing and rigorous quality assurance protocols.
• Regulators: Require transparency and traceability in the supply chain to prevent counterfeit or substandard products entering the market.
• Market Analysts: Should monitor raw material sourcing patterns, geopolitical developments, and regulatory changes affecting supplier operations.

Market Trends and Future Outlook

The global corticosteroid API market is projected to grow with rising demand for anti-inflammatory drugs. In the context of Eprontia, factors influencing supplier dynamics include:

• Regulatory tightening in API-exporting countries.
• Supply chain diversification to mitigate geopolitical risks.
• Technological innovations in manufacturing that may increase API yields or reduce costs.
• Emergence of regional manufacturing hubs driven by local regulations and demand.

Additionally, ongoing scrutiny of corticosteroid products’ manufacturing processes as part of pharmacovigilance initiatives may influence supplier standards and certifications.

Conclusion

The supply chain of Eprontia involves a confluence of API producers mainly based in India and China, formulation specialists, and regional manufacturing units—primarily in Latin America and Asia. Ensuring a reliable and compliant supplier network is critical for maintaining Eprontia's availability, safety, and efficacy. Stakeholders across the healthcare and pharmaceutical sectors must continuously monitor these suppliers, assessing geopolitical, regulatory, and technological trends impacting the supply chain.

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Key Takeaways

• Eprontia’s API sourcing primarily involves Indian and Chinese manufacturers who comply with international regulatory standards.
• Final formulation and sterile manufacturing are often regional, with Argentina’s PharmiWeb as a notable producer.
• Supply chain diversification and regulatory compliance remain critical for risk mitigation.
• Geopolitical tensions and regulatory changes could impact the availability of raw materials and finished products.
• Stakeholders should prioritize transparency, quality assurance, and strategic sourcing to ensure uninterrupted supply.

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FAQs

1. Who are the main API suppliers for dexamethasone used in Eprontia?
Major API suppliers include Dr. Reddy’s Laboratories, Mithra Pharmaceuticals, Laurus Labs (India), and Hubei Green State Pharmaceutical (China), all adhering to GMP standards.

2. What regulatory standards must suppliers of Eprontia meet?
Suppliers must comply with Good Manufacturing Practices (GMP), hold certifications from agencies like the US FDA or EMA, and meet national regulatory requirements in target markets.

3. How does supply chain diversification impact the availability of Eprontia?
Diversification reduces dependence on a single supplier or region, mitigating risks from geopolitical disruptions, production shortages, or regulatory issues.

4. Are there regional differences in Eprontia manufacturing?
Yes, Eprontia is produced regionally, notably in Argentina by PharmiWeb, which sources raw materials globally. Similar formulations are produced in Asia and other regions for local markets.

5. How might future market trends influence the supply of Eprontia?
Continued growth in corticosteroid demand, technological advances, and stricter regulations could shape supplier choices and manufacturing capacities, affecting supply stability.

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Sources

1. [1] Dr. Reddy’s Laboratories API production overview.
2. [2] Mithra Pharmaceuticals API manufacturing standards.
3. [3] Hubei Green State Pharmaceutical API offerings.
4. [4] Laurus Labs API certifications and compliance.
5. [5] Laboratorios Andrómaco manufacturing processes.

Note: All sources are indicative based on current industry reports and publicly available information.