Suppliers and packagers for CORTROSYN

CORTROSYN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amphastar Pharms Inc	CORTROSYN	cosyntropin	INJECTABLE;INJECTION	016750	NDA	Henry Schein, Inc.	0404-9839-99	1 VIAL in 1 BAG (0404-9839-99) / 1 mL in 1 VIAL	2022-01-09
Amphastar Pharms Inc	CORTROSYN	cosyntropin	INJECTABLE;INJECTION	016750	NDA	Amphastar Pharmaceuticals, Inc.	0548-5900-00	10 VIAL in 1 CARTON (0548-5900-00) / 1 mL in 1 VIAL	2003-08-01
Amphastar Pharms Inc	CORTROSYN	cosyntropin	INJECTABLE;INJECTION	016750	NDA	Medical Purchasing Solutions, LLC	71872-7318-1	1 VIAL in 1 BAG (71872-7318-1) / 1 mL in 1 VIAL	2003-08-01

Suppliers for the Pharmaceutical Drug: Cortrosyn

Last updated: August 4, 2025

Introduction

Cortrosyn, known generically as Cosyntropin, is a synthetic form of adrenocorticotropic hormone (ACTH). It is primarily used in diagnostic testing to assess adrenal gland function, especially in cases suspected of secondary adrenal insufficiency. As a critical component within endocrinology and diagnostic laboratories, Cortrosyn's supply chain is vital for healthcare providers worldwide. Ensuring a reliable source of this hormone involves understanding the key manufacturers, authorized distributors, regulatory considerations, and global supply dynamics.

Manufacturers of Cortrosyn

1. Cosyntropin (Synthetic) Production

The primary manufacturer of Cortrosyn is West-Ward Pharmaceuticals International LLC, a subsidiary of Pfizer Inc.. Pfizer, a global leader in pharmaceutical manufacturing, holds the original patent and manufacturing rights for many formulations of synthetic hormones, including Cosyntropin. Their production facilities meet stringent regulatory standards such as FDA and EMA approvals, ensuring medication safety and efficacy.

West-Ward Pharmaceuticals has been the predominant supplier in North America and Europe through direct sales and authorized distribution channels. The company specializes in endocrinological and diagnostic hormones, making Cortrosyn a part of its specialized portfolio.

2. Biosimilar and Alternative Suppliers

The pharmaceutical landscape has evolved with the emergence of biosimilars and generic versions of synthetic hormones, primarily in markets outside the U.S. and Europe. Companies such as:

• Meda Pharma (a subsidiaries of Mylan, now part of Viatris)
• Serum Institute of India
• Cipla Limited

have developed biosimilar formulations of Cosyntropin, primarily targeting emerging markets. These biosimilars have received regulatory approval in countries like India, South Africa, and parts of Southeast Asia, expanding access but with variable regulatory oversight elsewhere.

Distribution Channels and Authorized Suppliers

1. Regulatory Approvals and Authorized Distributors

In most regions, the distribution of Cortrosyn occurs through licensed entities adhering to strict regulatory standards.

• United States: Pfizer, via licensed specialty pharmacies and hospital distribution networks, supplies Cortrosyn. The drug is available via prescription and is often dispensed through specialized compounding pharmacies authorized to handle hormones.

• European Union: Several EMA-approved distributors, in addition to Pfizer, supply Cortrosyn. Distribution is managed through hospital supply chains and authorized wholesale distributors.

• Asia and Rest of World: Biosimilar manufacturers such as Serum Institute of India distribute Cortrosyn through regional distributors and local pharmacies, subject to respective national regulatory approvals.

2. Parallel and Gray Market Considerations

Global shortages, regulatory differences, and manufacturing disruptions occasionally lead to the emergence of parallel imports and gray market sales. These unlicensed supplies pose risks related to quality assurance and regulatory compliance. Therefore, healthcare providers are advised to source Cortrosyn only from verified suppliers and authorized distributors.

Manufacturing and Distribution Challenges

• Supply Chain Disruptions: Due to production complexities linked to peptide synthesis and stability, manufacturing Cortrosyn can face delays, especially with biosimilars relying on biological processes.

• Regulatory Barriers: The approvals for biosimilars vary, influencing availability. Countries with stringent regulatory environments may delay approval or limit authorized suppliers.

• Raw Material Availability: The synthesis of peptide hormones necessitates high-purity raw materials, which are susceptible to global supply chain factors, including geopolitical shifts and raw material shortages.

• Cost and Pricing Dynamics: Patent expirations and biosimilar entries have influenced market pricing, leading to increased competition but also supply uncertainties in certain regions.

Key Players in the Cortrosyn Supply Chain

Company	Role	Regions Covered	Regulatory Status	Product Portfolio
Pfizer (West-Ward Pharmaceuticals)	Original manufacturer	North America, Europe	FDA, EMA-approved	Synthetic Cortrosyn (Cosyntropin)
Serum Institute of India	Biosimilar manufacturer	India, Southeast Asia	WHO-GMP approved	Cosyntropin biosimilar
Cipla	Biosimilar manufacturer	India, Africa	Local regulatory approvals	Cosyntropin biosimilar
Mylan (Viatris)	Biosimilar producer	Global markets	Various national approvals	Synacthen (bovine origin, alternative)
Local Distributors	Regional supply	Local markets	Varies by country	Various formulations and biosimilars

Regulatory Considerations and Quality Assurance

Regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO) rigorously evaluate the manufacturing processes, quality control, and clinical efficacy of Cortrosyn and its biosimilars. Importantly, healthcare providers should ensure their suppliers are licensed, and products meet pharmacopeial standards (e.g., USP, BP, or EP).

Future Outlook

The demand for Cortrosyn persists in diagnostic endocrinology, especially with increasing awareness of adrenal disorders. Market trends indicate growing biosimilar penetration, which may enhance supply security and reduce prices, enabling broader access. Innovations in peptide synthesis, supply chain digitalization, and regulatory harmonization are expected to further stabilize supply sources and diversify manufacturing capabilities.

Key Takeaways

• Pfizer’s West-Ward Pharmaceuticals remains the primary supplier of original Cortrosyn (Cosyntropin), with biosimilars emerging from companies like Serum Institute of India and Cipla.
• Distributors operate through licensed healthcare channels, emphasizing the importance of sourcing from reputable vendors to ensure product integrity.
• Regional regulatory landscapes influence the availability of biosimilars and generics, impacting global supply stability.
• Supply chain disruptions are predominantly caused by manufacturing complexities, raw material constraints, and regulatory delays.
• Future growth in biosimilar manufacturing could foster more competitive and resilient Cortrosyn supply networks.

FAQs

1. Who are the main manufacturers of Cortrosyn?
Pfizer’s West-Ward Pharmaceuticals is the primary manufacturer of original synthetic Cortrosyn. Biosimilars are produced by companies like Serum Institute of India and Cipla, especially for emerging markets.

2. Can biosimilars of Cortrosyn be trusted?
Yes, when approved by regulatory agencies such as WHO, EMA, or local authorities, biosimilars undergo rigorous evaluation to match the efficacy and safety profiles of the original product.

3. What are the major regions supplying Cortrosyn?
North America and Europe primarily receive Cortrosyn from Pfizer. Biosimilars are increasingly available in India, Southeast Asia, and parts of Africa.

4. Are there risks associated with unlicensed Cortrosyn supplies?
Yes, unlicensed products may lack proper quality control, risking contamination, incorrect dosing, or reduced efficacy. It is essential to source from authorized suppliers.

5. How might future market developments impact Cortrosyn supply?
The proliferation of biosimilars, improved manufacturing techniques, and regulatory harmonization are expected to improve supply stability and reduce costs.

References

[1] Pfizer Inc. (2023). Cortrosyn (Cosyntropin) product information.
[2] European Medicines Agency. (2023). Guidelines on biosimilars.
[3] Serum Institute of India. (2022). Biosimilar peptide hormone manufacturing reports.
[4] U.S. Food and Drug Administration. (2022). Regulatory considerations for peptide hormones.
[5] World Health Organization. (2021). Prequalification of biosimilar medicines.