Suppliers and packagers for generic pharmaceutical drug: COSYNTROPIN

COSYNTROPIN

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: Cosyntropin

Last updated: July 31, 2025

Introduction

Cosyntropin, a synthetic form of adrenocorticotropic hormone (ACTH), is primarily used in diagnostic testing to assess adrenal gland function. Its applications extend into research domains, with occasional off-label uses in certain medical treatments. Ensuring a reliable supply chain for cosyntropin is vital for institutions operating in endocrine diagnostics and clinical research. This article provides a comprehensive overview of leading suppliers, manufacturing landscape, market dynamics, and strategic considerations related to cosyntropin procurement.

Understanding Cosyntropin: Market and Demand Drivers

Cosyntropin is generally supplied as a lyophilized powder for reconstitution, accessible in vials of varying potency (commonly 125 mcg or 250 mcg). Its demand aligns closely with the global prevalence of adrenal function testing, which has seen steady growth due to increasing awareness and the expansion of diagnostic capabilities.

The primary drivers influencing supply chains include:

• Expansion of endocrinology diagnostics
• Clinical research for adrenal disorders
• Regulatory approvals and healthcare infrastructure in emerging markets
• Patent expirations of branded formulations, fostering generics entry

Leading Suppliers and Manufacturers of Cosyntropin

1. Ferring Pharmaceuticals

Overview:
Ferring is a prominent provider of peptide-based pharmaceuticals, including cosyntropin, marketed under brand names like Acthrel in select regions. Their reputation hinges on rigorous manufacturing standards and global distribution networks.

Manufacturing and Supply:
Ferring maintains manufacturing facilities compliant with Good Manufacturing Practices (GMP), ensuring high purity and consistent potency. Their regional distribution covers North America, Europe, and parts of Asia. The company invests heavily in quality control, positioning itself as a reliable supplier, especially for sensitive diagnostic hormones.

2. Alliance Pharmaceuticals

Overview:
Alliance Pharmaceuticals supplies cosyntropin primarily in North America, focusing on diagnostic and research markets. Their portfolio emphasizes peptide hormones, with flexible manufacturing capacities.

Supply Dynamics:
They often offer both original and generic versions, with a focus on rapid supply responsiveness to diagnostic laboratories and research institutions.

3. Spectrum Chemical Manufacturing Corp.

Overview:
Spectrum Chemicals and Pharmaceuticals supplies bulk peptides, including synthetic ACTH analogs like cosyntropin, mainly catering to research institutions and pharmaceutical companies.

Product Characteristics:
Spectrum offers cosyntropin in research-grade purity, not always authorized for diagnostic use, emphasizing its role in laboratory research rather than clinical diagnostics.

4. Chinese and Indian Generics Manufacturers

Overview:
Emerging markets are witnessing increased production of cosyntropin by manufacturers such as Wockhardt, Sun Pharmaceutical Industries, and others. These entities leverage lower manufacturing costs to produce generic formulations.

Market Impact:
While these generics expand affordability and supply, quality assurance is crucial. Regulatory approval varies across regions, influencing their market stability.

5. Other Notable Suppliers

• Sigma-Aldrich (Merck Millipore): Known for research-grade peptides with periodic availability for research purposes.
• Novartis and Roche: Historically involved in hormone analog manufacture; currently limited but historically relevant stakeholders in ACTH derivatives.

Regulatory and Quality Considerations

Quality assurance is paramount when sourcing cosyntropin, especially for clinical diagnostics or therapeutic research. Suppliers operating under strict GMP compliance, with cleared approvals from the FDA, EMA, or other regional regulators, are preferred. The differentiation often lies in batch-to-batch consistency, stability, and the absence of contaminants.

Supply Chain Challenges

• Regulatory Hurdles: Variability in approvals across countries hampers global distribution.
• Manufacturing Complexity: Peptide synthesis requires advanced technology, limiting some manufacturers.
• Market Fluctuations: Patent expirations push shifts from branded to generic suppliers, affecting pricing and availability.
• Supply Disruptions: Pandemics, geopolitical issues, or raw material shortages can impact supply stability.

Future Outlook and Strategic Sourcing

The cosyntropin market is gradually evolving, with an emphasis on biosimilar and generic formulations. As the demand for reliable, high-quality supply increases, buyers should prioritize suppliers with demonstrated regulatory compliance and proven manufacturing capabilities.

Strategically, institutions should establish diversified supplier relationships, consider long-term contracts, and monitor regulatory landscapes to prevent supply disruptions. Additionally, emerging regional manufacturers must demonstrate quality standards comparable to global leaders to gain market acceptance.

Key Takeaways

• Market Leaders: Ferring Pharmaceuticals remains the dominant global supplier due to its extensive manufacturing and distribution capabilities.
• Generics Expansion: Indian and Chinese manufacturers are increasing their market share, offering more affordable options but requiring diligent quality assessment.
• Regulatory Compliance: Sourcing from GMP-compliant suppliers ensures product efficacy and safety, reducing the risk of diagnostic inaccuracies.
• Supply Chain Vigilance: Persistent geopolitical, logistical, and regulatory challenges necessitate strategic diversification and sourcing agility.
• Future Trends: Growth in biosimilars and biosynthetic peptides is anticipated, potentially reshaping the supply landscape for cosyntropin.

FAQs

1. Is cosyntropin available as a generic in the market?
Yes, several generic manufacturers, particularly in India and China, produce cosyntropin, often at lower prices than branded options. However, buyers should verify regulatory approvals and quality certifications before procurement.

2. What are the primary regions where cosyntropin is supplied?
Supplies are concentrated in North America, Europe, and parts of Asia. Emerging markets are increasingly accessible due to the entry of regional generic manufacturers.

3. How can healthcare providers ensure the quality of cosyntropin supply?
By sourcing from GMP-certified suppliers with FDA or EMA approvals, reviewing batch certificates, and performing periodic quality tests for potency and purity.

4. What are the main technical challenges in manufacturing cosyntropin?
Peptide synthesis complexity and maintaining peptide stability during storage and transportation. Advanced manufacturing facilities are essential for consistent product quality.

5. Are biosimilar cosyntropin products available?
While biosimilars for cosyntropin are emerging, regulatory approval and market acceptance vary by region, and clinicians should verify these products' regulatory status before use.

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References

[1] Ferring Pharmaceuticals. Product Information and Regulatory Approvals.

[2] United States Food and Drug Administration (FDA). Guidance for Industry on Peptide Drugs.

[3] MarketWatch. Endocrinology Diagnostic Market Growth & Trends.

[4] Indian Pharmaceutical Market Reports. Rising Generic Production Capacities.

[5] European Medicines Agency (EMA). Peptide-Based Diagnostic Agents Regulation.