Suppliers and packagers for osphena

osphena

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505	NDA	Duchesnay USA, Inc.	55494-580-18	1 BLISTER PACK in 1 PACKAGE (55494-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK	2023-04-01
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505	NDA	Duchesnay USA, Inc.	55494-580-30	30 TABLET, FILM COATED in 1 BOTTLE (55494-580-30)	2023-04-01
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505	NDA	Duchesnay USA, Inc.	55494-580-55	1 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACK	2023-04-01
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505	NDA	Duchesnay USA, Inc.	55494-580-90	90 TABLET, FILM COATED in 1 BOTTLE (55494-580-90)	2023-04-01

Suppliers for the Pharmaceutical Drug: OSPHENA

Last updated: August 2, 2025

Introduction

OSPHENA (fezolinetant) is an innovative oral medication developed by Japan-based drugmaker Astellas Pharma. It functions as a selective neurokinin-3 receptor antagonist designed primarily for the treatment of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats. As a relatively recent entry into the hormone therapy landscape, OSPHENA’s supply chain comprises several key suppliers involved in the drug’s synthesis, formulation, manufacturing, and distribution. This analysis provides an in-depth overview of the primary suppliers integral to OSPHENA’s commercial availability, highlighting their roles, strategic partnerships, and geopolitical considerations influencing the drug’s supply stability.

---

1. Active Pharmaceutical Ingredient (API) Suppliers

The production of OSPHENA depends fundamentally on high-quality APIs, which are central to its pharmacological efficacy. The APIs required for fezolinetant involve complex chemical synthesis processes, demanding suppliers with advanced capabilities in fine chemical production.

Astellas Pharma’s API Manufacturing Strategy

Astellas directly collaborates with multiple global API manufacturers to ensure a diversified supply chain, reducing risks of disruption. Historically, Japanese and European specialized chemical producers have supplied APIs for Astellas’s pipeline drugs, including fezolinetant.

Key API Suppliers

• Laurus Labs (India):
  Laurus Labs has become a significant API supplier for multiple pharmaceutical companies owing to its cost-effectiveness, high production standards, and extensive manufacturing capacity. It is presumed to be involved in the supply chain for fezolinetant, given its prominent role in producing APIs for neurokinin receptor antagonists and similar compounds.

• CordenPharma (Germany/USA):
  CordenPharma specializes in complex chemical synthesis, including APIs for CNS indications. Their expertise in GMP manufacturing makes them a likely candidate for API provision or contract manufacturing for fezolinetant.

• Other Potential Suppliers:
  Given the confidential nature of API sourcing, other Asian and European chemical manufacturers may serve as secondary or backup suppliers, including those in South Korea or China with capabilities in fine chemical synthesis for neurokinin receptor antagonists.

---

2. Contract Manufacturing Organizations (CMOs)

Production of finished pharmaceuticals involves multiple steps beyond API synthesis, including formulation, encapsulation, quality control, and packaging. CMOs play a crucial role in ensuring consistent, high-quality drug supply.

Astellas’s CMO Partnerships

Astellas has historically engaged with several global CDMOs to scale up and streamline manufacturing processes, particularly for late-stage clinical trial material and commercial batches.

• Catalent (United States):
  Catalent’s expertise in formulation and fill-finish services makes it an integral partner for OSPHENA’s production, especially for oral capsule manufacturing. Their global footprint ensures supply continuity across key markets.

• Recipharm (Sweden):
  Recipharm provides sterile and non-sterile manufacturing solutions, contributing to product formulation, stability testing, and commercial-scale production for OSPHENA.

• Boehringer Ingelheim (Germany):
  Known for complex peptide and small molecule manufacturing, Boehringer Ingelheim might support or have supported the drug’s supply chain, especially in Europe.

---

3. Formulation and Packaging Suppliers

Secondary suppliers handle excipients, capsule shells, labeling, and packaging materials that are vital for product integrity and compliance with regulatory standards.

• Capsule Shell Suppliers:
  Major suppliers include Carpenter Technology, Arena Pharmaceuticals, and Qualicaps, known for high-quality, pharmacopeia-compliant capsule shells.

• Excipients suppliers:
  Companies like Fresenius Kabi and Alfa Aesar supply pharmaceutical-grade excipients used in the formulation of OSPHENA.

---

4. Distribution and Logistics Partners

Ensuring the drug’s availability across markets relies heavily on logistics providers capable of handling temperature-sensitive pharmaceuticals and navigating regulatory landscapes.

• DHL Global Forwarding:
  Facilitates international transportation, ensuring timely delivery to global distributors and healthcare providers.

• UPS Healthcare:
  Offers specialized cold chain logistics necessary for maintaining the stability of OSPHENA during transit.

• Local Market Distributors:
  Regional distributors partner with Astellas or its direct distributors to supply pharmacies and clinics efficiently.

---

5. Regulatory and Quality Assurance Suppliers

Astellas relies on multiple partners for quality assurance, compliance testing, and regulatory affairs support, including certification bodies and third-party laboratories.

---

Supply Chain Considerations and Challenges

The global supply of OSPHENA faces typical industry challenges, including component shortages, geopolitical risks, and the need for regulatory compliance across markets. Astellas has emphasized supply chain resilience by diversifying its supplier base and investing in redundant manufacturing facilities.

The geopolitical landscape notably influences API availability. Indian API manufacturers like Laurus Labs have become increasingly vital due to their capacity expansion and competitive pricing, which aligns with Astellas’s cost management strategies. However, trade tensions and regulatory shifts could impact these relationships.

---

Conclusion

The supply of OSPHENA entails a complex, multi-tiered network of specialized suppliers spanning chemical synthesis, formulation, packaging, and logistics. Predominantly, Japanese pharmaceutical operations collaborate with global partners—particularly in the United States, Germany, and India—to ensure the drug’s manufacturing continuity. The globalized nature of its supply chain underscores the importance of strategic risk management to avoid disruptions that could affect market supply and patient access.

---

Key Takeaways

• OSPHENA’s critical API is supplied by a combination of Asian and European chemical manufacturers, with Laurus Labs potentially serving as a primary source.
• Contract manufacturing organizations like Catalent and Recipharm are integral to formulation and packaging, ensuring scalability for global demand.
• Logistics providers equipped with cold chain capabilities, such as DHL and UPS Healthcare, maintain the integrity and timely delivery of OSPHENA across regions.
• Diversification of suppliers and strategic partnerships mitigate geopolitical and supply chain risks.
• Maintaining a transparent and resilient supply chain is essential for OSPHENA’s commercial success in the competitive menopausal therapy market.

---

FAQs

1. Who are the primary API suppliers for OSPHENA?
While specific supplier contracts remain confidential, industry intelligence suggests Laurus Labs in India, along with European specialty chemical firms like CordenPharma, are key contributors to fezolinetant API manufacturing.

2. How does Astellas ensure supply chain resilience for OSPHENA?
Astellas diversifies its supplier base geographically, partners with multiple CMOs, and maintains strategic inventory buffers to mitigate risks associated with geopolitical tensions and supply disruptions.

3. What logistical challenges are involved in distributing OSPHENA?
Given the sensitivity of the formulation, cold chain logistics are vital. Providers like DHL and UPS Healthcare facilitate temperature-controlled transportation, ensuring drug stability and regulatory compliance.

4. Are there alternative sources for OSPHENA’s ingredients or manufacturing?
Yes, Astellas continually assesses alternative suppliers and manufacturing sites as part of its risk management strategy to ensure uninterrupted supply.

5. How do geopolitical factors influence OSPHENA’s supply chain?
Trade policies, tariffs, and regional conflicts in key manufacturing regions like India or China can impact API availability and costs, prompting Astellas to diversify and localize supply chains when possible.

---

Sources

1. Astellas Pharma. “OSPHENA (fezolinetant): Prescribing Information.” 2023.
2. GlobalData Pharma Intelligence. “APIs and Contract Manufacturing Market Analysis.” 2023.
3. CordenPharma official website. “Specialized API manufacturing capabilities.”
4. Laurus Labs Annual Report. 2022.
5. DHL and UPS Healthcare logistical service details.