Suppliers and packagers for epaned

epaned

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	EPANED	enalapril maleate	SOLUTION;ORAL	208686	NDA	Wilshire Pharmaceuticals, Inc.	52536-401-01	1 BOTTLE in 1 CARTON (52536-401-01) / 150 mL in 1 BOTTLE	2024-04-08
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686	NDA	Azurity Pharmaceuticals, Inc.	52652-4001-1	150 mL in 1 BOTTLE (52652-4001-1)	2016-10-03
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals NY LLC	69238-2141-7	1 BOTTLE in 1 CARTON (69238-2141-7) / 150 mL in 1 BOTTLE	2022-03-23

Suppliers for the Pharmaceutical Drug: Epaned

Last updated: July 30, 2025

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Introduction

Epaned (enalapril oral solution) is a prescription medication used primarily for the management of hypertension and heart failure. As a liquid formulation of enalapril, an angiotensin-converting enzyme (ACE) inhibitor, Epaned offers an alternative to traditional tablet forms, particularly benefiting pediatric and sensitive adult populations. Ensuring an uninterrupted supply chain for Epaned is vital for healthcare providers, pharmacies, and patients dependent on this medication. This article examines the key suppliers involved in the production and distribution of Epaned, highlighting the manufacturing landscape, regulatory considerations, and market dynamics.

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Manufacturers of Epaned

1. Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical, based in Japan, is the original developer and primary manufacturer of Epaned. Since its approval by the U.S. Food and Drug Administration (FDA) in 2007, Otsuka has maintained a significant role in the production and distribution of Epaned in North America. Their manufacturing facilities operate under stringent quality control standards, adherent to Good Manufacturing Practices (GMP), ensuring product consistency.

2. Contract Manufacturing Organizations (CMOs)**

Given the complex processes involved in liquid pharmaceutical production, Otsuka often collaborates with specialized CMOs to meet global demand. These partners include:

• Fresenius Kabi: A global leader in intravenous and oral medications, known for manufacturing enalapril solutions under strict regulatory oversight. Fresenius Kabi's extensive experience in sterile liquid formulations makes it a key CMO partner for Otsuka in certain markets.

• Hikma Pharmaceuticals: A multinationalcapability in sterile and liquid formulations, Hikma has been involved in the production of enalapril oral solutions for various markets, ensuring supply chain flexibility and capacity expansion.

• Alfasigma: An Italian pharmaceutical company with expertise in cardiovascular drugs, including enalapril formulations. Alfasigma ramps up production capacity through strategic licensing agreements with Otsuka.

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Supply Chain Dynamics

The supply of Epaned depends on a multifaceted network involving raw material suppliers, manufacturing plants, and distribution channels:

a. Raw Material Suppliers

The principal active pharmaceutical ingredient (API) used in Epaned is enalapril maleate. Key API suppliers include:

• Dr. Reddy’s Laboratories: India-based pharmaceutical manufacturer supplying enalapril maleate API to Otsuka for formulation.

• Zhejiang Huahai Pharmaceutical Co., Ltd.: Chinese API producer recognized for high-quality enalapril maleate, supplying to multiple GMP-compliant manufacturers globally.

• MSH (Muscat Pharmaceutical & Chemicals Co.) and other regional API suppliers also participate, contingent on regional regulations and supply agreements.

b. Packaging Material Suppliers

• Vials and Syringes: Suppliers such as Gerresheimer and Nipro Corporation provide sterile glass vials and pre-filled syringes used for Epaned.

• Labels and Packaging Films: Companies like WestRock and Amcor supply multi-layer packaging materials conforming to pharmaceutical standards.

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Regulatory Considerations and Market Approvals

The distribution of Epaned is regulated by international agencies like the FDA, EMA, and other national authorities. Companies involved in manufacturing or importing Epaned must maintain compliance with GMP standards and obtain necessary approvals. For example:

• FDA Approval: Epaned’s approval as a liquid enalapril formulation has been critical for its distribution across the US.
• EMA Authorization: European market approvals involve compliance with EMA regulations, with licensed manufacturing sites authorized under centralized or decentralized procedures.

Manufacturers and suppliers secure regulatory approvals to ensure product safety, quality, and efficacy, which influences their market access and distribution capacity.

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Market Dynamics and Competition

While Otsuka remains the principal supplier, the market landscape features competitors or alternative formulations from:

• Teva Pharmaceuticals: Produces enalapril tablets, with some capacity to manufacture liquid forms via licensing.

• Mylan (now part of Viatris): Traditionally supplies generic enalapril tablets, but has partnered with CMOs for liquid formulations in specific markets.

• Sandoz and Dr. Reddy’s: Both entities manufacture generic ACE inhibitors, including enalapril solutions, primarily for markets with high demand for affordable medications.

The competitive landscape is shaped by patent protections, regulatory approvals, and the capacity of contract manufacturers, affecting procurement strategies for healthcare providers.

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Supply Challenges

• Raw Material Shortages: Disruptions in the supply of the API, especially from regions like China and India, can impact production schedules.

• Regulatory Hurdles: Stringent country-specific requirements can delay or restrict the import and distribution of Epaned.

• Global Disruptions: Pandemics, geopolitical conflicts, and logistics issues potentially cause delays in manufacturing and distribution, underscoring the importance of diversified suppliers.

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Conclusion

The global supply chain for Epaned hinges on a consortium of manufacturers, contract manufacturers, and regional suppliers. Otsuka Pharmaceutical remains the core producer, leveraging collaborations with established CMOs to meet demand. The procurement of enalapril API from reputable suppliers in India and China underpins manufacturing resilience, although geopolitical and regulatory changes may influence supply stability. Understanding these supplier relationships is critical for stakeholders to ensure continuous access to this essential medication.

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Key Takeaways

• Otsuka Pharmaceutical predominates as the primary manufacturer of Epaned, utilizing partnerships with CMOs like Fresenius Kabi and Hikma to expand production.
• API supply chains are concentrated among major Indian and Chinese producers, with firms like Dr. Reddy’s and Zhejiang Huahai leading.
• Regulatory compliance remains a decisive factor in manufacturing and distribution, with approvals from agencies such as the FDA and EMA vital for market access.
• Global supply disruptions highlight the importance of diversified sourcing and strategic inventory management.
• Competition from generic manufacturers influences pricing, availability, and supply efficiency.

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FAQs

1. Who are the main manufacturers of Epaned?
Primarily, Otsuka Pharmaceutical is the original manufacturer. It collaborates with contract manufacturing organizations such as Fresenius Kabi, Hikma, and Alfasigma to meet market demands.

2. Where does the enalapril API used in Epaned originate?
Most enalapril maleate API is sourced from large-scale producers in India (Dr. Reddy’s) and China (Zhejiang Huahai), complying with international GMP standards.

3. Are there alternative suppliers for Epaned?
Yes, several generic pharmaceutical companies, including Teva and Mylan, produce enalapril solutions, though their distribution of Epaned-specific formulations varies by region.

4. What regulatory considerations impact supply?
Manufacturers must adhere to GMP standards set by agencies like the FDA and EMA; any regulatory delays or restrictions can impact the availability of Epaned.

5. How do supply chain disruptions affect Epaned access?
Disruptions in API sourcing, manufacturing capacity, or logistics—exacerbated by global crises like pandemics—can result in shortages, necessitating strategic inventory management and supplier diversification.

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References

1. U.S. Food and Drug Administration (FDA). Epaned (Enalapril) NDA approval. [Online] Available at: https://www.accessdata.fda.gov
2. Otsuka Pharmaceutical Co., Ltd. Corporate Overview. [Online] Available at: https://www.otsuka.co.jp
3. Zhejiang Huahai Pharmaceutical Co., Ltd. API manufacturing profile. [Online] Available at: http://www.huahaipharm.com
4. FMCG and pharma supply chain publications. Market Analysis Reports.
5. European Medicines Agency (EMA). Drug approvals and compliance guidelines.