Suppliers and packagers for generic pharmaceutical drug: ILOPROST

ILOPROST

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Btg Intl	AURLUMYN	iloprost	SOLUTION;INTRAVENOUS	217933	NDA	BTG International Inc	50633-340-01	1 VIAL, SINGLE-DOSE in 1 CARTON (50633-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE	2025-08-01

Suppliers for the Pharmaceutical Drug: Iloprost

Last updated: July 27, 2025

Introduction

Iloprost is a synthetic analogue of prostacyclin (PGI2), primarily used for managing pulmonary arterial hypertension (PAH) and certain vascular conditions. Its potent vasodilatory properties make it a critical therapeutic agent in treating conditions associated with elevated pulmonary artery pressure. As a specialty pharmaceutical, iloprost's supply chain involves multiple manufacturers, including brand-name producers and generics, with distribution spanning global markets. This analysis offers a comprehensive overview of key suppliers of iloprost, examining their manufacturing capabilities, market presence, regulatory considerations, and strategic implications for stakeholders.

Manufacturers of Iloprost

BASF SE

Founded in 1865, BASF is among the pioneering manufacturers of iloprost. The company produces iloprost as part of its specialty pharmaceuticals portfolio, supplying both bulk active pharmaceutical ingredients (APIs) and finished formulations. BASF's extensive global manufacturing infrastructure ensures consistent quality and supply, supported by robust regulatory compliance in major markets including the United States, Europe, and Asia. Notably, BASF’s supply networks are supported by its large-scale chemical synthesis facilities, making it a dominant supplier globally.

Chiesi Farmaceutici S.p.A.

An Italian pharmaceutical company, Chiesi specializes in developing and distributing respiratory and specialty medicines. Chiesi markets Ilomedin®, a brand of iloprost for inhalation and infusion, predominantly in Europe and select Asian markets. Their integrated manufacturing facilities enable quality control and supply chain stability. Chiesi’s strategic focus on pulmonary hypertension therapies aligns their production capacity with clinical demand, positioning them as a key regional supplier.

Sinphar Group

Based in Taiwan, Sinphar Group manufactures iloprost in various formulations, including inhalation solutions and infusion preparations. Their regional presence in Asia-Pacific makes Sinphar a significant supplier for markets in that area, with expanding distribution channels in other regions. Sinphar leverages advanced pharmaceutical manufacturing technologies, meeting international regulatory standards such as cGMP, to serve diverse healthcare systems.

Mikrogen (part of Mikrogen Pharma)

Mikrogen Pharma, a lesser-known entity, manufactures generic versions of iloprost, primarily targeting emerging markets. Their supply capacity focuses on providing affordable alternatives to branded iloprost formulations, often in countries with limited access to expensive imported drugs. Mikrogen emphasizes cost-effective production processes compliant with regional regulatory bodies for market approval.

Other Suppliers & Generics Manufacturers

Several regional generic pharmaceutical companies and API producers supply iloprost, including firms in Korea, India, and eastern Europe. Companies like Zydus Cadila (India) and Samsung BioLogics (South Korea) have emerging portfolios of prostacyclin analogues or generic vasodilators, including iloprost, aiming to capture growing demand in developing markets.

Regulatory and Quality Considerations

The supply of iloprost is tightly regulated due to its use in critical care and pulmonary hypertension management. Suppliers must comply with global standards such as the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and other regional regulatory authorities' cGMP guidelines. Product approval depends on rigorous stability testing, reproducible manufacturing processes, and comprehensive pharmacovigilance programs. These regulatory requirements can impact supplier choices and supply continuity.

Global Market Dynamics and Supply Chain Challenges

The market landscape for iloprost faces several challenges. Supply chain disruptions, including raw material shortages and manufacturing bottlenecks, can impact availability. Recent trends show increased demand driven by broader recognition of pulmonary hypertension therapies and expanded indications. Suppliers with diversified manufacturing sites and flexible logistics networks mitigate risks of shortages.

Additionally, geopolitical factors and trade policies influence supplier reliability, especially for regions dependent on imports. For instance, European and North American markets rely heavily on BASF and Chiesi, whereas Asian markets benefit from regional manufacturers like Sinphar and Mikrogen. Strategic partnerships, licensing agreements, and regional manufacturing licenses further streamline supply flows.

Strategic Implications for Stakeholders

For pharmaceutical companies and healthcare providers, understanding the supplier landscape of iloprost is crucial for ensuring uninterrupted access and strategic procurement. Contracting with multiple suppliers mitigates risk exposure, especially amid geopolitical tensions or unforeseen disruptions. Moreover, cultivating relationships with generic manufacturers can provide cost-effective alternatives, particularly for resource-constrained settings. Regulatory agility and maintaining compliance are vital for sustaining supply chain integrity.

Furthermore, emerging biosimilar and bioconjugate developments may reshape the competitive landscape over the next decade, encouraging existing suppliers to innovate or expand production capabilities. Stakeholders should closely monitor regulatory developments, patent expirations, and technological advancements influencing iloprost's manufacturing lifecycle.

Conclusion

The supply of iloprost is dominated by a handful of established manufacturers, including BASF, Chiesi, Sinphar, and emerging regional generic producers. Their global footprint, adherence to stringent regulatory standards, and strategic capacity planning underpin the drug’s availability in markets worldwide. As demand for pulmonary hypertension therapy grows, supply chain resilience, collaboration, and regulatory compliance will remain critical factors shaping the future landscape of iloprost procurement.

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Key Takeaways

• Major suppliers include BASF and Chiesi, with regional manufacturers like Sinphar and Mikrogen playing vital roles in Asia-Pacific and emerging markets.
• Regulatory compliance with authorities such as EMA and FDA ensures quality and stability in supply.
• Diversifying supply sources and fostering strategic partnerships mitigate risks of shortages and logistical disruptions.
• Market growth driven by increasing pulmonary hypertension awareness requires suppliers to expand manufacturing capacity and innovate.
• Staying informed about regulatory developments and patent landscapes is essential for strategic procurement and competitive positioning.

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FAQs

Q1: What is the primary regulatory challenge faced by iloprost suppliers?
A1: Ensuring compliance with diverse regional standards such as EMA and FDA regulations, particularly regarding manufacturing quality, stability testing, and pharmacovigilance, is a key challenge that influences market approval and supply stability.

Q2: Are there generic alternatives to brand-name iloprost?
A2: Yes, several regional generic manufacturers produce iloprost, often at lower costs, expanding access, especially in emerging markets. These generics must meet regulatory standards comparable to branded products to ensure safety and efficacy.

Q3: How do geopolitical factors affect iloprost supply?
A3: Trade restrictions, political tensions, and regional conflicts can disrupt raw material access, manufacturing operations, and distribution channels, impacting the overall supply chain of iloprost globally.

Q4: What role does regional manufacturing play in the ilaoprost supply chain?
A4: Regional manufacturing enhances supply security by reducing dependency on single global sources, enables quicker response to local demand, and complies with regional regulatory requirements, ensuring more resilient supply chains.

Q5: What future trends could influence iloprost supply?
A5: Advances in biosimilar development, potential patent expirations, and innovations in inhalation and infusion technologies may reshape the procurement landscape, providing both challenges and opportunities for existing and new suppliers.

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Sources:

1. [1] European Medicines Agency. "Iloprost Summary for the Public." EMA, 2022.
2. [2] BASF SE. "Active Ingredients Portfolio," BASF, 2023.
3. [3] Chiesi Farmaceutici. "Ilomedin® Product Data." Chiesi, 2022.
4. [4] Sinphar Group. "Pharmaceutical Manufacturing Capabilities," Sinphar, 2023.
5. [5] GlobalData. "Pulmonary Hypertension Market and Supply Chain Analysis," 2023.