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: February 19, 2026

Orserdu (elacestrant), approved by the U.S. Food and Drug Administration (FDA) on January 27, 2023, is a selective estrogen receptor degrader (SERD) indicated for adult patients with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one endocrine therapy [1]. The manufacture and supply chain for Orserdu involve multiple specialized entities, from active pharmaceutical ingredient (API) synthesis to finished drug product formulation and packaging.

Who Manufactures the Active Pharmaceutical Ingredient (API)?

The primary active pharmaceutical ingredient for Orserdu is elacestrant. Information regarding the specific contract manufacturing organizations (CMOs) responsible for the large-scale synthesis of elacestrant is typically proprietary and not publicly disclosed by the innovator company, Stemline Therapeutics, Inc., a Menarini Group company. However, API manufacturing for complex molecules like elacestrant often involves specialized chemical synthesis capabilities. Key considerations for API suppliers include:

Chemical Synthesis Expertise: Proficiency in multi-step organic synthesis, chiral chemistry, and purification techniques.
Regulatory Compliance: Adherence to Current Good Manufacturing Practices (cGMP) as mandated by regulatory bodies like the FDA, EMA, and others. This includes rigorous quality control, process validation, and documentation.
Capacity and Scalability: Ability to produce API in quantities sufficient to meet global demand, with the flexibility to scale up or down as needed.
Intellectual Property Protection: Robust systems to safeguard manufacturing processes and trade secrets.
Supply Chain Security: Redundancy and risk mitigation strategies to ensure uninterrupted supply.

While direct supplier names for elacestrant API are not publicly available, typical global suppliers for oncology APIs with high regulatory standards include companies based in North America, Europe, India, and China. These firms often have established relationships with pharmaceutical innovators for both clinical trial material and commercial supply.

Who Formulates and Fills the Finished Drug Product?

The formulation of Orserdu into its final dosage form (tablets) and the subsequent filling and packaging operations are critical stages. This process requires specialized facilities capable of handling solid oral dosage manufacturing under strict cGMP conditions.

Key Contract Manufacturing Organizations (CMOs) for Finished Dosage Forms

While Stemline Therapeutics may have internal manufacturing capabilities, the pharmaceutical industry commonly outsources formulation and finished product manufacturing to specialized CMOs. Identifying specific CMOs for Orserdu's finished product is challenging without direct disclosure from Stemline. However, typical requirements for such CMOs include:

Solid Oral Dosage Manufacturing: Expertise in tablet compression, coating, and blistering.
cGMP Compliance: Facilities audited and approved by major regulatory agencies.
Quality Assurance and Control: Robust systems for raw material testing, in-process controls, and finished product release.
Packaging and Labeling: Capabilities for primary and secondary packaging, including serialization and track-and-trace requirements.
Analytical Services: In-house or contracted laboratories for method development, validation, and release testing.

Companies that frequently serve the pharmaceutical industry in this capacity include Lonza, Catalent, Thermo Fisher Scientific (Patheon), and Siegfried AG. These organizations offer integrated services from API handling to finished product release.

Packaging and Distribution Suppliers

The packaging of Orserdu ensures product stability, safety, and compliance with regulatory labeling requirements. Distribution involves a complex network to deliver the drug to pharmacies and healthcare providers globally.

Packaging Materials

Primary Packaging: Typically consists of blister packs made from materials like polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), or aluminum foil, designed to protect the tablets from moisture, light, and oxygen.
Secondary Packaging: Includes folding cartons, labels, and patient information leaflets, which must conform to strict regulatory standards for readability and content.
Tertiary Packaging: Shipping containers designed for secure transport.

Suppliers for these materials are numerous and globally distributed. Pharmaceutical-grade packaging material manufacturers must adhere to stringent quality standards and often require specific certifications.

Distribution and Logistics

The distribution of finished Orserdu is managed through a specialized pharmaceutical supply chain. This typically involves:

Third-Party Logistics (3PL) Providers: Companies specializing in the warehousing, inventory management, and transportation of pharmaceuticals. These providers must operate under GDP (Good Distribution Practices) regulations. Examples include AmerisourceBergen, Cardinal Health, and McKesson in the U.S.
Cold Chain Management: While Orserdu does not appear to require strict cold chain storage based on its labeling information, maintaining controlled room temperature is standard for most oral solid dosage forms.
Serialization and Track-and-Trace: To combat counterfeiting and ensure product integrity, manufacturers and distributors must comply with serialization regulations (e.g., U.S. DSCSA, EU FMD). This involves unique product identifiers applied at the unit level and tracking through the supply chain.

Regulatory and Quality Oversight

All entities involved in the manufacturing and supply chain of Orserdu are subject to rigorous regulatory oversight.

Key Regulatory Bodies

U.S. Food and Drug Administration (FDA): Oversees manufacturing processes, quality control, and facility inspections in the United States.
European Medicines Agency (EMA): Regulates drug manufacturing and supply within the European Union.
Other National Regulatory Agencies: Equivalent bodies in countries where Orserdu is marketed.

These agencies conduct regular inspections to ensure compliance with cGMP and GDP standards. Any deviations can result in significant penalties, including product recalls and manufacturing halts.

Quality Management Systems

Suppliers are required to have robust Quality Management Systems (QMS) in place. These systems cover:

Document Control: Management of all procedural documents, batch records, and specifications.
Change Control: Formal procedures for managing any changes to processes, materials, or equipment.
Deviations and CAPA: Systems for investigating and addressing any deviations from established procedures and implementing Corrective and Preventive Actions.
Supplier Qualification: Processes for vetting and approving all suppliers of raw materials, components, and services.
Auditing: Regular internal and external audits to ensure ongoing compliance.

Conclusion

The Orserdu supply chain, like that of most advanced pharmaceuticals, is a complex network involving specialized API manufacturers, finished drug product CMOs, and sophisticated logistics providers. While specific supplier identities are often confidential, the operational requirements for these partners—spanning advanced synthesis, stringent cGMP compliance, robust quality systems, and secure distribution—are well-defined and dictated by global regulatory standards. The successful and uninterrupted supply of Orserdu relies on the meticulous selection and ongoing oversight of these critical partners.

Key Takeaways

Orserdu's API, elacestrant, is manufactured by specialized chemical synthesis firms operating under strict cGMP.
Finished dosage form manufacturing (tablet formulation, filling, and packaging) is likely outsourced to experienced CMOs with expertise in oral solid dose production.
A network of packaging material suppliers and specialized pharmaceutical logistics providers ensures product integrity and delivery.
All entities in the supply chain are subject to rigorous regulatory oversight by agencies like the FDA and EMA, necessitating robust Quality Management Systems.
Supply chain security, scalability, and adherence to serialization requirements are paramount for uninterrupted global access to Orserdu.

Frequently Asked Questions

What is the primary role of a CMO in the Orserdu supply chain? A Contract Manufacturing Organization (CMO) is responsible for the large-scale synthesis of the active pharmaceutical ingredient (API) or the formulation, manufacturing, and packaging of the finished drug product (tablets) according to the innovator company's specifications and regulatory standards.
How is the quality of Orserdu API ensured during manufacturing? API quality is ensured through adherence to Current Good Manufacturing Practices (cGMP), which include stringent process validation, raw material testing, in-process controls, finished API release testing by qualified analytical laboratories, and regular audits by regulatory agencies.
What are the key challenges in securing suppliers for a novel oncology drug like Orserdu? Challenges include identifying suppliers with the necessary specialized technical expertise (e.g., complex organic synthesis for API, advanced formulation for tablets), ensuring their robust cGMP compliance history, verifying their capacity and scalability for global demand, and negotiating terms that protect intellectual property while ensuring supply chain resilience.
Does Orserdu require special storage or handling conditions throughout its supply chain? Based on available product information, Orserdu is a solid oral dosage form typically requiring controlled room temperature storage, not specialized cold chain conditions. However, adherence to defined storage parameters is critical throughout the supply chain to maintain product stability.
What regulatory requirements govern the distribution of Orserdu? The distribution of Orserdu is governed by Good Distribution Practices (GDP), which mandate standards for warehousing, transportation, and traceability to ensure product quality and integrity. Compliance with serialization and track-and-trace regulations is also a critical component of distribution.

Citations

[1] U.S. Food & Drug Administration. (2023, January 27). FDA approves Orserdu (elacestrant) for postmenopausal women or adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-orserdu-elacestrant-postmenopausal-women-or-adult-men-er-her2-esr1-mutated-advanced-or

Suppliers and packagers for orserdu

orserdu

Orserdu Supplier Landscape