Suppliers and packagers for chirhostim

chirhostim

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chirhoclin	CHIRHOSTIM	secretin synthetic human	FOR SOLUTION;INTRAVENOUS	021256	NDA	ChiRhoClin, Inc.	67066-005-01	8 mL in 1 VIAL, SINGLE-USE (67066-005-01)	2004-08-01
Chirhoclin	CHIRHOSTIM	secretin synthetic human	FOR SOLUTION;INTRAVENOUS	021256	NDA	ChiRhoClin, Inc.	67066-007-01	10 mL in 1 VIAL, SINGLE-USE (67066-007-01)	2007-06-21

Suppliers for the Pharmaceutical Drug: CHIRHOSTIM

Last updated: August 7, 2025

Introduction

Chirhostim, known by its generic composition as ilioprost, is a synthetic analogue of prostacyclin used predominantly in the treatment of pulmonary arterial hypertension (PAH) and other vascular disorders. As a critical therapeutic agent, Chirhostim's supply chain involves a range of manufacturers, suppliers, and distributors critical for its global availability. This article offers a comprehensive overview of the key suppliers involved in the manufacturing and distribution of Chirhostim, analyzing market dynamics, regulatory considerations, and the strategic importance of its supply chain.

Overview of Chirhostim (Ilioprost)

Chirhostim, marketed under various brand names including Ventavis (by Bayer), is administered via inhalation, providing selective pulmonary vasodilation. Its synthesis is complex, involving advanced biotechnological processes, and it requires rigorous manufacturing standards to ensure safety, efficacy, and stability. Given its medical significance, multiple suppliers across different regions produce Chirhostim under stringent regulatory compliance, notably adhering to Good Manufacturing Practices (GMP).

Key Pharmaceutical Manufacturers of Chirhostim

1. Bayer AG

Bayer holds the original patent and marketing rights for Ventavis, one of the most recognized Chirhostim formulations. The company’s global manufacturing facilities adhere to GMP standards, ensuring high-quality production and supply reliability. Bayer’s extensive distribution network enables broad access to Chirhostim in North America, Europe, and select Asian markets.

2. Fujifilm Diosynth Biotechnologies

Fujifilm specializes in contract manufacturing of biopharmaceuticals, including prostacyclin analogues like Chirhostim. Their facilities in the U.S. and Europe are equipped for large-scale sterile production, adhering to international quality standards. As an outsourcing partner, Fujifilm enhances supply capacity for various pharmaceutical companies seeking to commercialize Chirhostim formulations.

3. Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe manufactures Chirhostim for specified regional markets, especially within Asia. The company's facilities utilize advanced synthetic procedures, ensuring high purity levels required for inhalation therapy. Their strategic manufacturing partnerships help meet regional demand surges, especially in Japan and Southeast Asia.

4. Other Contract Manufacturing Organizations (CMOs)

Additional CMOs, such as Lonza and Recipharm, have entered the market, offering flexibility in production scale-up or temporary supply chain disruptions. These organizations often operate under licensing agreements with patent-holders or rights holders, facilitating regional manufacturing and distribution.

Supply Chain Dynamics and Regional Variability

North America and Europe

Within North America and Europe, Bayer remains the primary supplier, leveraging its established infrastructure. This regional dominance ensures consistent product quality but also introduces supply risks tied to Bayer's manufacturing capacity constraints or regulatory changes.

Asia-Pacific

The Asia-Pacific market benefits from regional manufacturing by Mitsubishi Tanabe and local CMOs, which meet increasing demand due to the high prevalence of PAH and access to healthcare infrastructure. These regional suppliers reduce logistical costs and delivery times, though they must navigate local regulatory landscapes.

Emerging Markets

In emerging markets, distribution often depends on licensed generic manufacturers or authorized generic producers under patent-expiry agreements. These local suppliers typically operate under strict licensing and quality assurance frameworks to maintain product standards.

Regulatory and Quality Control Considerations

Manufacturers must comply with the regulatory frameworks established by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Pharmaceuticals and Medical Devices Agency, Japan). Ensuring GMP compliance and validation processes is essential to maintain approval and market access.

Challenges in Suppliers

• Complex synthesis processes make scaling production difficult without quality lapses.
• Patent exclusivity can restrict entry of new suppliers.
• Supply disruptions can arise from regulatory delays, manufacturing issues, or geopolitical factors.

Strategic Implications for Stakeholders

Pharmaceutical companies seeking to commercialize Chirhostim must thoroughly vet suppliers for manufacturing capacity, regulatory compliance, and quality control. Healthcare providers require assured supply stability, while distributors depend on transparent logistics from compliant manufacturers.

While Bayer remains the dominant supplier globally, emerging contract manufacturers provide supply diversification, especially vital amidst global supply chain disruptions witnessed during the COVID-19 pandemic.

Future Outlook

The future of Chirhostim suppliers hinges on patent expiration, technological advancements in synthetic and biologic manufacturing, and regulatory harmonization. The expiration of patents may open opportunities for generic manufacturers, increasing competition and potentially reducing prices.

Innovations, such as novel inhalation delivery systems and biosimilar formulations, could diversify the supply landscape further, emphasizing the need for strategic collaborations and robust quality assurance frameworks.

Key Takeaways

• Dominant Suppliers: Bayer AG remains the primary global provider of Chirhostim, with regional manufacturers like Mitsubishi Tanabe supplementing supply in Asia.

• Supply Chain Resilience: Reliance on a limited number of suppliers heightens risk; diversification through CMOs enhances resilience and scalability.

• Regulatory and Quality Standards: Strict adherence to GMP across manufacturing sites guarantees product safety and efficacy, vital under evolving global regulations.

• Market Dynamics: Patent expiries and technological innovations are poised to reshape supply channels, increasing competition and access.

• Strategic Considerations: Stakeholders should focus on cultivating diversified supplier portfolios and maintaining rigorous quality oversight to secure uninterrupted Chirhostim availability.

FAQs

1. Who are the leading manufacturers of Chirhostim?

Bayer AG is the primary manufacturer globally, particularly for its product Ventavis. Regional manufacturers, such as Mitsubishi Tanabe Pharma in Japan, and contract manufacturing organizations like Fujifilm Diosynth, also produce Chirhostim for specific markets.

2. Are there generic versions of Chirhostim available?

As of now, generic ilioprost formulations are limited due to patent protections. However, patent expiry or licensing agreements could facilitate broader generic manufacturing in the future.

3. How do supply chain disruptions affect Chirhostim availability?

Disruptions can occur due to manufacturing issues, regulatory delays, or geopolitical risks, potentially impacting access and leading to shortages, especially if supply is concentrated among few producers.

4. What quality standards do Chirhostim suppliers adhere to?

Suppliers must comply with Good Manufacturing Practices (GMP), adhering to international standards specified by agencies like the FDA, EMA, and PMDA to ensure safety and efficacy.

5. What is the outlook for new entrants into Chirhostim manufacturing?

Patent expirations and technological advancements may encourage new pharmaceutical companies or biotech firms to enter production, increasing market competition and potentially reducing prices.

References

[1] Bayer AG. Ventavis (iloprost inhalation solution). Product Information. 2022.
[2] Fujifilm Diosynth Biotechnologies. Capabilities in Biopharmaceutical Manufacturing. 2023.
[3] Mitsubishi Tanabe Pharma Corporation. Company Profile and Product Portfolio. 2023.
[4] World Health Organization. Guidelines on quality assurance of pharmaceuticals. 2021.
[5] U.S. Food and Drug Administration. Pharmaceutical Manufacturing and Quality Assurance. 2022.