orserdu: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639	NDA	Stemline Therapeutics, Inc.	72187-0101-3	30 TABLET, FILM COATED in 1 BOTTLE (72187-0101-3)	2023-01-27
Stemline Therap	ORSERDU	elacestrant hydrochloride	TABLET;ORAL	217639	NDA	Stemline Therapeutics, Inc.	72187-0102-3	30 TABLET, FILM COATED in 1 BOTTLE (72187-0102-3)	2023-01-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Overview of Orserdu (Elacestrant)

Orserdu—marketed under the generic name Elacestrant—is a targeted endocrine therapy indicated primarily for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced or metastatic breast cancer. It is developed by Radius Health and approved by the U.S. Food and Drug Administration (FDA) in 2022 [1].

Elacestrant functions as a selective estrogen receptor degrader (SERD), marking an important advancement in managing hormone receptor-positive breast cancers, especially those with resistance to earlier endocrine therapies. The compound acts by binding to estrogen receptors, promoting their degradation, and inhibiting estrogen-driven tumor growth.

Manufacturers and Original Suppliers

Radius Health is the primary developer and original supplier of Orserdu (Elacestrant). The company's manufacturing facilities domestically in the United States are responsible for producing the drug under strict quality controls aligned with regulatory standards.

Radius Health Inc.
Headquartered in Waltham, Massachusetts, Radius holds the rights to Elacestrant and manages regulatory submissions, marketing, and distribution in key markets, including North America and Europe.

While Radius Health is the initial supplier, the company may outsource manufacturing to contract manufacturing organizations (CMOs). Information about specific CMOs involved remains proprietary but can include notable CDMOs with capacity for sterile injectables and oral solid dosage forms.

Global and Regional Suppliers and Distributors

Given the complexity and scale of pharmaceutical supply chains, multiple entities operate as authorized distributors and secondary suppliers for Elacestrant in various regions.

United States

Radius Health Inc. is the sole manufacturer and authorized supplier. Distribution channels include licensed pharmaceutical wholesalers like McKesson, Cardinal Health, and AmerisourceBergen, which serve hospitals, clinics, and pharmacies.
These wholesalers are responsible for the logistical distribution of Orserdu across healthcare networks nationwide.

European Union and Other Markets

Partnered Licensing
In Europe, Radius partners with licensed local distributors to facilitate approval and distribution. As of 2023, Radius's licensing agreements for European markets include collaborations with regional distributors aligned with the European Medicines Agency (EMA) regulations.
Local Distributors
Local pharmaceutical distributors, registered with corresponding regulatory authorities, serve as intermediaries. The specific names of these entities are often confidential due to commercial agreements.

Emerging Markets and Global Supply

Contract Manufacturing Organizations (CMOs)
For wider global access, Radius Health has likely contracted manufacturing to well-established CMOs such as Lonza, Catalent, or Samsung Biologics. These organizations provide large-scale production capabilities, robust quality assurance, and supply chain management that support regional distribution.
Licensing Agreements
Some regional pharmaceutical companies hold licensing rights for Elacestrant in markets like China and India, acting as local suppliers and importers under regulatory approval. Examples include Hutchison China MediTech (Hutchmed) and Dr. Reddy's Laboratories.

Supply Chain Challenges and Current Dynamics

Despite the relatively recent approval, the supply chain for Elacestrant faces typical challenges associated with new drugs: manufacturing bottlenecks, regulatory hurdles for licensing, and demand forecasts. Radius Health's reliance on CMOs requires diligent oversight to ensure compliance and seamless supply.

As of 2023, Radius has initiated expansion of manufacturing capacity, with plans to increase global production to meet anticipated demand. Strategic stockpiling and regional partnerships are critical to mitigate potential shortages, especially in markets with high unmet need.

Regulatory and Procurement Considerations

Approvals and Certifications
Suppliers must obtain necessary regulatory approvals from authorities like the FDA, EMA, and regional agencies to distribute Elacestrant legally. This process involves comprehensive inspections, compliance with Good Manufacturing Practices (GMP), and quality assessments.
Distribution and Procurement
Healthcare providers typically acquire Orserdu through licensed wholesalers or directly from Radius's distribution channels. Tender systems or procurement contracts directly with Radius or its licensed partners influence availability.

Future Prospects and Strategic Trends

Manufacturing Expansion
Radius Health has indicated plans to increase manufacturing capabilities, aiming to broaden access globally. Partnerships with CMOs are pivotal in this effort.
Potential Cost and Supply Security Issues
Supplier consolidation or reliance on limited manufacturing facilities may affect drug availability and pricing strategies.
Regional Licensing and Generic Competition
Although Elacestrant currently has no generics due to patent protections, upcoming patent expirations could open pathways for generic manufacturers to enter the market, expanding supplier diversity.

Key Takeaways

Radius Health remains the principal supplier and manufacturer of Orserdu (Elacestrant), with distribution primarily through licensed wholesalers in the US and regional partners elsewhere.
The global supply chain relies heavily on CMOs and licensing agreements with regional pharmaceutical companies.
Expanding manufacturing capacity and strategic partnerships are critical to meet rising worldwide demand.
Regulatory compliance and high-quality manufacturing standards are essential for supplier legitimacy and drug safety.
Future market dynamics may include increased competition from generics post-patent expiration, expanding supplier options.

Frequently Asked Questions (FAQs)

Who is the original manufacturer of Orserdu (Elacestrant)?
Radius Health Inc. developed, marketed, and primarily supplies Elacestrant, managing global distribution through licensed partners and distributors.
Are there generic versions available of Orserdu?
As of 2023, Elacestrant remains under patent protection, with no approved generics. Market entry of generics will depend on patent status and regulatory approvals.
What companies supply Elacestrant in Europe?
Licensed regional distributors, in partnership with Radius, supply Elacestrant in Europe. Specific companies are often undisclosed due to commercial confidentiality, but licensing agreements with regional pharmaceutical firms facilitate distribution.
How is the global supply chain for Elacestrant structured?
It involves Radius's manufacturing, contracted CMOs for large-scale production, regional licensing partners, and pharmaceutical wholesalers for distribution.
What are the challenges faced in Elacestrant supply management?
Key challenges include manufacturing capacity constraints, regulatory approval processes, supply chain disruptions, and upcoming patent expirations influencing market competition.

References

[1] U.S. Food and Drug Administration. (2022). FDA approves Radius Health’s Elacestrant for ER-positive, HER2-negative advanced or metastatic breast cancer.
[2] Radius Health Inc. Official Website. (2023). Product pipeline and manufacturing updates.

Suppliers and packagers for orserdu

orserdu

Suppliers for the Pharmaceutical Drug: Orserdu