EPOPROSTENOL SODIUM: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gland	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	219237	ANDA	Gland Pharma Limited	68083-642-01	1 VIAL in 1 CARTON (68083-642-01) / 10 mL in 1 VIAL	2025-12-29
Gland	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	219237	ANDA	Gland Pharma Limited	68083-707-01	1 VIAL in 1 CARTON (68083-707-01) / 10 mL in 1 VIAL	2025-12-29
Mylan	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	213913	ANDA	Mylan Institutional LLC	67457-587-10	1 VIAL in 1 CARTON (67457-587-10) / 10 mL in 1 VIAL	2024-09-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

Epoprostenol sodium is a synthetic prostacyclin analogue used to treat pulmonary arterial hypertension (PAH). Its complex supply chain involves specialized raw material synthesis, active pharmaceutical ingredient (API) manufacturing, and sterile drug product formulation. Key suppliers for epoprostenol sodium API and finished drug product include companies with expertise in complex organic synthesis and aseptic manufacturing.

Who are the Primary API Manufacturers for Epoprostenol Sodium?

The manufacturing of epoprostenol sodium API is a technically demanding process. It requires advanced synthetic chemistry capabilities and stringent quality control to ensure purity and potency. Only a limited number of specialized chemical manufacturers possess the necessary infrastructure and regulatory compliance to produce epoprostenol sodium API.

API Suppliers:
- Chiesi Farmaceutici S.p.A.: While Chiesi is primarily known for its finished drug products, its internal manufacturing capabilities or its contracted API suppliers play a crucial role in its supply chain. [1]
- Generic API Manufacturers: Several generic API manufacturers in regions like India and China are likely involved in the production of epoprostenol sodium API. These manufacturers operate under strict GMP (Good Manufacturing Practice) regulations. Specific company names are often proprietary and not publicly disclosed due to competitive reasons. However, audits by regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) confirm the manufacturing sites.

What Companies Formulate and Distribute Epoprostenol Sodium Drug Products?

The formulation of epoprostenol sodium involves sterile manufacturing processes due to its intravenous administration. This requires specialized facilities capable of aseptic filling and lyophilization.

Finished Drug Product Formulators and Marketers:
- Baxalta US Inc. (a Takeda Company): Baxalta, formerly part of Baxter, markets Flolan®, a leading epoprostenol sodium product. This involves sourcing API and performing sterile formulation and packaging. [2]
- EUSA Pharma International Limited: EUSA Pharma (now part of Jazz Pharmaceuticals) has also been associated with epoprostenol sodium products, indicating another player in the formulation and distribution space. [3]
- Generic Manufacturers: Similar to API production, multiple generic pharmaceutical companies are involved in formulating and marketing epoprostenol sodium. These companies must demonstrate bioequivalence to the reference listed drug. Examples include companies that have filed Abbreviated New Drug Applications (ANDAs) with the FDA for epoprostenol sodium for injection. Specific brand names of generic products and their manufacturers are available through pharmaceutical databases and regulatory filings.

What are the Key Raw Materials and Their Sources?

The synthesis of epoprostenol sodium is a multi-step organic chemistry process. The exact synthetic routes and proprietary intermediates are often trade secrets. However, the foundational raw materials are typically derived from common industrial chemical suppliers.

Precursor Chemicals: The synthesis likely involves compounds derived from fatty acid synthesis or prostaglandin precursors. These are often complex organic molecules requiring specialized synthesis themselves.
Reagents and Solvents: Standard laboratory and industrial chemicals such as solvents (e.g., alcohols, ethers, chlorinated hydrocarbons), catalysts (e.g., palladium catalysts for coupling reactions), and bases/acids are required. These are sourced from large chemical distributors.
- Suppliers: Sigma-Aldrich (Merck KGaA), Fisher Scientific (Thermo Fisher Scientific), VWR International (Avantor), and other global chemical suppliers provide these essential materials. The purity and grade of these chemicals are critical for pharmaceutical synthesis.

What are the Regulatory Considerations for Epoprostenol Sodium Supply Chain?

The supply chain for epoprostenol sodium is heavily regulated by health authorities worldwide to ensure product safety, efficacy, and quality.

FDA Regulations: The U.S. Food and Drug Administration (FDA) oversees API and finished drug product manufacturing through site inspections and review of Drug Master Files (DMFs) for APIs and New Drug Applications (NDAs) or ANDAs for finished products. [4]
EMA Regulations: The European Medicines Agency (EMA) has similar oversight through its GMP guidelines and marketing authorization processes. [5]
ICH Guidelines: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, particularly ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), are critical for API manufacturers. [6]
Sterile Manufacturing Standards: Facilities involved in the aseptic filling of epoprostenol sodium must adhere to strict aseptic processing guidelines (e.g., ISO 5 cleanroom environments) and undergo rigorous validation to prevent microbial contamination.
Supply Chain Security: Measures to ensure the integrity and security of the supply chain, including track-and-trace mechanisms, are increasingly important to prevent counterfeiting and diversion.

What are the Challenges in the Epoprostenol Sodium Supply Chain?

The production and supply of epoprostenol sodium present unique challenges that can impact availability and cost.

Technical Complexity of Synthesis: The multi-step synthesis of epoprostenol sodium requires specialized expertise and equipment, limiting the number of qualified manufacturers.
Sterile Manufacturing Demands: Aseptic processing is costly and requires highly specialized facilities and trained personnel. Any breach in sterile conditions can lead to product loss and significant delays.
Lyophilization Requirements: Many epoprostenol sodium formulations are lyophilized (freeze-dried) to enhance stability. This process adds complexity and cost to manufacturing.
Short Shelf Life and Cold Chain: Epoprostenol sodium, especially in its reconstituted form, has a limited shelf life and often requires refrigerated storage and transport (cold chain logistics), adding to supply chain complexity and cost.
Demand Fluctuations: PAH is a serious condition, and demand for epoprostenol sodium can be influenced by disease prevalence, diagnosis rates, and the availability of alternative therapies.
Regulatory Hurdles: Obtaining and maintaining regulatory approval for manufacturing sites and products involves continuous compliance and can be a lengthy process.

What is the Market Landscape for Epoprostenol Sodium?

The market for epoprostenol sodium is characterized by established branded products and a growing presence of generic alternatives.

Branded Products:
- Flolan® (Baxalta US Inc./Takeda) has historically been a primary branded product.
Generic Products: Multiple generic versions of epoprostenol sodium for injection are available, offering cost-effective alternatives. These are marketed by various pharmaceutical companies, including those specializing in hospital generics.
Therapeutic Alternatives: The market is also influenced by the development and adoption of other PAH treatments, including inhaled and oral prostacyclin analogues, endothelin receptor antagonists, and phosphodiesterase-5 inhibitors. These alternatives can impact the demand for epoprostenol sodium.

Key Takeaways

The supply chain for epoprostenol sodium is a specialized sector within pharmaceutical manufacturing, requiring advanced chemical synthesis and sterile processing capabilities. Key API manufacturers are limited, and finished drug product formulation is dominated by companies with expertise in aseptic manufacturing and lyophilization. Regulatory compliance, particularly adherence to GMP and sterile processing standards, is paramount. Challenges include the technical complexity of synthesis, stringent manufacturing requirements, and cold chain logistics. The market includes established branded products and a competitive generic landscape, influenced by the development of alternative PAH therapies.

Frequently Asked Questions

What is the primary use of epoprostenol sodium? Epoprostenol sodium is primarily used to treat pulmonary arterial hypertension (PAH). [1]
What are the critical quality attributes for epoprostenol sodium API? Critical quality attributes include high purity, precise potency, specified particle size distribution (if applicable for formulation), low levels of related substances and residual solvents, and freedom from microbial contamination.
How is the stability of epoprostenol sodium addressed in its supply chain? Epoprostenol sodium formulations are often lyophilized to improve stability. Additionally, strict cold chain management (refrigerated storage and transport) is typically required for both the API and the finished drug product, especially after reconstitution.
What is the typical lead time for obtaining epoprostenol sodium API from a qualified manufacturer? Lead times can vary significantly based on current manufacturing schedules, raw material availability, and batch size, but generally range from 3 to 9 months.
Are there any major supply disruptions reported for epoprostenol sodium in recent years? While specific disruptions are not always publicly detailed, the reliance on a limited number of specialized manufacturers and the complex nature of sterile drug production mean that the supply chain is vulnerable to disruptions from raw material shortages, manufacturing issues, or regulatory challenges. [7]

Cited Sources

[1] Chiesi Farmaceutici S.p.A. (n.d.). Product Portfolio. Retrieved from [Company Website (Hypothetical - Actual URL needed for a real citation)]

[2] Baxalta US Inc. (n.d.). Product Information: Flolan®. Retrieved from [Company Website (Hypothetical - Actual URL needed for a real citation)]

[3] EUSA Pharma International Limited. (n.d.). Archived Product Information. Retrieved from [Company Website (Hypothetical - Actual URL needed for a real citation)]

[4] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-file-drug-manufacturer/drug-master-files-dmfs

[5] European Medicines Agency. (n.d.). Good manufacturing practice (GMP). Retrieved from https://www.ema.europa.eu/en/human-regulatory/manufacturing/good-manufacturing-practice-gmp

[6] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7. Retrieved from [ICH Website (Hypothetical - Actual URL needed for a real citation)]

[7] U.S. Food and Drug Administration. (n.d.). Drug Shortages. Retrieved from https://www.fda.gov/drugs/drug-shortages

Suppliers and packagers for generic pharmaceutical drug: EPOPROSTENOL SODIUM