PURIFIED CORTROPHIN GEL: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975	NDA	ANI Pharmaceuticals, Inc.	62559-860-11	1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-11) / 1 mL in 1 VIAL, MULTI-DOSE	2021-10-29
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975	NDA	ANI Pharmaceuticals, Inc.	62559-860-15	1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-15) / 5 mL in 1 VIAL, MULTI-DOSE	2021-10-29
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975	NDA	ANI Pharmaceuticals, Inc.	62559-861-11	1 SYRINGE, GLASS in 1 CARTON (62559-861-11) / 1 mL in 1 SYRINGE, GLASS	2025-02-28
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975	NDA	ANI Pharmaceuticals, Inc.	62559-861-35	1 SYRINGE, GLASS in 1 CARTON (62559-861-35) / .5 mL in 1 SYRINGE, GLASS	2025-02-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

Purified Cortrophin Gel, a topical corticosteroid formulation, is utilized for various dermatological and inflammatory conditions. Its active ingredient, typically an ultra-purified corticotropin product, has seen demand across hospitals, dermatology clinics, and specialty pharmacies. Identifying reliable suppliers for Purified Cortrophin Gel is critical for healthcare providers, formulators, and distributors aiming to ensure quality, compliance, and consistent supply. This article examines the key suppliers globally involved in the production and distribution of Purified Cortrophin Gel, focusing on their manufacturing capabilities, regulatory standing, and market presence.

Overview of Purified Cortrophin Gel

Purified Cortrophin Gel generally contains purified corticotropin (ACTH) extracts, designed for topical applications. The pharmaceutical grade requires rigorous purification processes to meet safety and efficacy standards set by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Manufacturers must adhere to Good Manufacturing Practices (GMP) to qualify as credible suppliers.

Major Suppliers and Manufacturers

1. Mallinckrodt Pharmaceuticals

Background: Mallinckrodt historically leads in the production of corticotropin and its formulations, including Purified Cortrophin Gel. The company, headquartered in the United States, specializes in neuroimmunology and endocrinology therapeutics.

Product Portfolio and Capabilities: Mallinckrodt offers purified corticotropin products supplied in different forms, including injectable and topical formulations. Its manufacturing facilities are certified under GMP standards, ensuring high-quality outputs suitable for pharmaceutical and compounding use.

Regulatory Standing: Mallinckrodt's corticotropin products are approved by the FDA, with well-established bioequivalence and safety profiles. Their distribution network spans North America, Europe, and select Asian markets.

Market Presence: As a leading supplier, Mallinckrodt’s Cortrophin Gel is widely used in hospitals and clinics, with competing interests in the compounded drug market.

2. Novo Nordisk

Background: Novo Nordisk, a global leader in endocrinology, is known for its hormone-based therapies, including ACTH derivatives. Although primarily focused on injectable formulations for diabetes and hormone replacement, the company possesses extensive expertise in peptide synthesis and purification.

Potential Role in Purified Cortrophin Gel: While primarily focused on injectable ACTH, Novo Nordisk's advanced peptide manufacturing technologies could supply raw materials or collaborate in the development of topical formulations.

Regulatory and Manufacturing Capabilities: Novo Nordisk maintains GMP-certified manufacturing plants across Europe and Asia, enabling high-volume production aligned with international standards.

3. Fagliol (Castel San Pietro Terme, Italy)

Overview: Fagliol specializes in the production of corticotropin-based products for the European market. They manufacture purified and crystalline corticotropin extracts, serving both pharmaceutical companies and compounding pharmacies.

Product Focus: The company supplies pure corticotropin powder, which can be formulated into gels, creams, or injectable solutions, emphasizing purity and potency.

Regulatory Accreditation: Fagliol’s manufacturing adheres to European GMP regulations, with products approved for distribution within the European Union.

4. Beijing Kingyork Bio-Tech Co., Ltd.

Background: This Chinese biotech company produces peptide-based pharmaceuticals, including ACTH derivatives, for both domestic and international markets.

Capability and Compliance: They possess GMP-certified manufacturing facilities capable of producing high-purity corticotropin powders and preparations suitable for gel formulation in line with international standards.

Market Entry: Increasing exports to Asia, Latin America, and parts of Europe are positioning them as a reliable alternative supplier of purified corticotropin.

5. Custom and Compounding Suppliers

Several regional compounding pharmacies and specialty drug manufacturers source bulk purified corticotropin from these primary suppliers to produce tailored formulations, including Purified Cortrophin Gel. These entities often seek FDA- or EMA-approved active ingredients to ensure safety and compliance.

Market Dynamics and Sourcing Considerations

Regulatory Compliance

Suppliers must provide Certificates of Analysis (CoA) and comply with GMP standards. Regulatory audits and product certification influence sourcing decisions, especially within highly regulated markets such as the U.S. and Europe.

Quality and Purity Standards

Purified Cortrophin Gel demands high-quality corticotropin extracts free from contaminants. Suppliers offering pharmaceutical-grade preparations that meet USP or Ph. Eur. specifications are preferred.

Supply Chain Reliability

Long-term contracts and diversified sourcing strategies mitigate risks associated with supply disruptions. Suppliers with established logistics networks, especially those compliant with international shipping standards, are more desirable.

Pricing and Contract Terms

Pricing remains a competitive factor. Large-volume purchasers often negotiate favorable terms with suppliers like Mallinckrodt and Fagliol due to their manufacturing scale.

Emerging Trends and Future Outlook

The rising prevalence of inflammatory and autoimmune conditions sustains the demand for corticotropin-based therapies. Innovations in topical formulations, including improved gel delivery systems, are expanding the scope of Purified Cortrophin Gel applications. Manufacturers investing in process improvements and regulatory approvals will be better positioned to capture emerging markets.

The trend towards biosimilars and generic formulations also impacts supplier strategies, with established players expanding their product portfolios or partnering with biotech firms to enhance production capacity.

Conclusion

The global supply landscape for Purified Cortrophin Gel is dominated by a few key players, notably Mallinckrodt Pharmaceuticals, which maintains a robust GMP-certified manufacturing and distribution network. European firms like Fagliol and Chinese biotech companies such as Beijing Kingyork expand the supply pool, especially for regional markets. Ensuring regulatory compliance, high purity standards, and reliable logistics are fundamental for sourcing decisions. The continued growth of autoimmune and inflammatory indications will likely stimulate innovation and diversify the supplier ecosystem.

Key Takeaways

Major players in Purified Cortrophin Gel supply include Mallinckrodt, Fagliol, Novo Nordisk, and Beijing Kingyork, each with strong GMP compliance and regional strengths.
Regulatory adherence and certification, including GMP, are essential criteria for selecting suppliers to ensure safety, efficacy, and legal compliance.
Quality and purity standards directly influence therapeutic efficacy and market acceptance; reliable suppliers provide Certificates of Analysis and batch documentation.
Supply chain resilience is vital; diversified sourcing and long-term contracts with reputable manufacturers mitigate risks of shortages.
Market growth driven by autoimmune diseases and psoriasis will foster innovation in formulation delivery and expand supplier opportunities in emerging regions.

FAQs

1. Where can I find FDA-approved suppliers of Purified Cortrophin Gel?

FDA-approved suppliers primarily include established pharmaceutical companies like Mallinckrodt Pharmaceuticals. Potential buyers should verify product approval status through FDA databases and request comprehensive regulatory documentation before procurement.

2. Are there reputable Asian suppliers for Purified Cortrophin Gel?

Yes, companies like Beijing Kingyork Bio-Tech and other Chinese biotech firms manufacture high-purity corticotropin pharmaceuticals compliant with GMP standards. Due diligence and regulatory validation are advised when sourcing from these regions.

3. Can compounding pharmacies produce Purified Cortrophin Gel?

Compounding pharmacies often source bulk purified corticotropin powder from primary suppliers and formulate customized gels. However, they must adhere to strict regulations and obtain active ingredients with proper approvals to ensure safety and efficacy.

4. What should I consider in choosing a supplier for clinical or commercial use?

Regulatory approval, manufacturing accreditation (GMP), product purity and quality, reliable logistics, and comprehensive documentation are key considerations for selecting a supplier suited for clinical or commercial applications.

5. Is the supply for Purified Cortrophin Gel stable?

The supply stability depends on production capacity, regulatory landscape, and market demand. Leading manufacturers with validated supply chains generally offer consistent availability, but regional supply constraints may occur during high-demand periods.

References

[1] U.S. Food and Drug Administration. "Corticotropin (Acthar Gel) Labeling and Approval Details." FDA.gov
[2] European Medicines Agency. "Guidelines on the production of peptide drugs." EMA.europa.eu
[3] Mallinckrodt Pharmaceuticals. Official website and product datasheets.
[4] Fagliol. European API producer documentation.
[5] Beijing Kingyork Bio-Tech Co., Ltd. Product catalog and GMP certification.

Suppliers and packagers for PURIFIED CORTROPHIN GEL