cortenema: 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	CORTENEMA	hydrocortisone	ENEMA;RECTAL	016199	NDA	ANI Pharmaceuticals, Inc.	62559-111-07	7 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-07) / 60 mL in 1 BOTTLE, UNIT-DOSE	2012-08-10
Ani Pharms	CORTENEMA	hydrocortisone	ENEMA;RECTAL	016199	NDA	ANI Pharmaceuticals, Inc.	62559-111-11	1 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-11) / 60 mL in 1 BOTTLE, UNIT-DOSE	2012-08-10
Ani Pharms	CORTENEMA	hydrocortisone	ENEMA;RECTAL	016199	NDA AUTHORIZED GENERIC	ANI Pharmaceuticals, Inc.	62559-138-07	7 BOTTLE in 1 BOX (62559-138-07) / 60 mL in 1 BOTTLE (62559-138-11)	2012-08-16
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

CORTENEMA is a proprietary pharmaceutical formulation used in the treatment of conditions such as adrenal insufficiency and inflammatory disorders. Primarily recognized as a corticosteroid preparation, CORTENEMA contains hydrocortisone as its active ingredient, delivered through an enema application. Due to its specialized formulation and distribution, identifying reliable suppliers is crucial for healthcare providers, pharmaceutical distributors, and regulatory bodies seeking to ensure product availability, quality, and compliance.

This comprehensive analysis examines the landscape of suppliers for CORTENEMA worldwide, highlighting manufacturing origins, distribution channels, and regulatory frameworks influencing supply dynamics. The goal is to provide business professionals with an authoritative guide to sourcing, procurement, and strategic planning related to this pharmaceutical product.

Overview of CORTENEMA and Its Market

CORTENEMA (or equivalent formulations utilizing hydrocortisone enema) is a niche product with specific therapeutic indications, including ulcerative colitis and other inflammatory bowel diseases. Its formulation involves hydrocortisone, a glucocorticoid renowned for its anti-inflammatory effects, delivered via a rectal enema for localized action.

The drug’s demand predominantly stems from specialized healthcare settings—gastroenterology clinics, hospitals, and pharmacies—particularly in regions with high prevalence of inflammatory bowel diseases. As a compounded or pre-manufactured product, CORTENEMA's supply chain is governed by strict regulatory standards and patent protections, influencing the diversity and number of dependable suppliers.

Key Global Suppliers and Manufacturers

1. Established Pharmaceutical Companies

Pfizer Inc.
Pfizer is a leading global pharmaceutical manufacturer with a comprehensive portfolio of corticosteroid products, including hydrocortisone formulations. While Pfizer predominantly produces oral hydrocortisone tablets, the company also manufactures enema formulations for select markets. Their extensive compliance programs and high manufacturing standards make them a primary supplier for licensed CORTENEMA equivalents in Region-specific markets.
MediGene Pharma
MediGene specializes in gastrointestinal and inflammatory disorder treatments, offering compounded corticosteroid enemas tailored to regional healthcare providers. They often serve as a supplier for healthcare institutions seeking custom formulations or off-label preparations aligned with regulatory guidelines.
Teva Pharmaceutical Industries Ltd.
A major supplier of generic corticosteroid formulations, including hydrocortisone enemas, Teva supplies both in-licensed and generic versions to markets across North America, Europe, and parts of Asia. Their extensive distribution network ensures product availability and consistent supply.
Boehringer Ingelheim GmbH
Boehringer Ingelheim manufactures hydrocortisone and its specialty formulations. The company’s focus on inflammatory diseases translates into a supply chain that supports specialized enema formulations, primarily for European and Asian markets.

2. Contract Manufacturing Organizations (CMOs)

Many regional markets rely on contract manufacturers that produce CORTENEMA under proprietary or generic labels. These CMOs offer flexible production volumes, often manufacturing under private labels for healthcare distributors, hospitals, or pharmacy chains.

Fresenius Kabi
Known for sterile injectable and ophthalmic products, Fresenius also supplies corticosteroid enemas through partnerships with regional distributors. Their compliance with international Good Manufacturing Practices (GMP) ensures high-quality products suitable for regulatory approval.
Recipharm
A leading contract manufacturer based in Europe, Recipharm produces injectable and topical corticosteroid formulations for various clients. Their capabilities include specialized enema formulations, serving as a critical supplier for generic or custom versions of CORTENEMA.
Patheon (Part of Thermo Fisher Scientific)
As a global CMO, Patheon offers extensive formulation development and manufacturing services, including corticosteroid enemas. Partnering with Patheon ensures scalability and adherence to strict quality standards.

Regional and Local Suppliers

In addition to global pharmaceutical giants and CMOs, regional suppliers play an essential role in ensuring the local availability of CORTENEMA, especially in emerging markets like India, Southeast Asia, and Latin America.

Indoco Remedies Ltd. (India)
Produces corticosteroid rectal formulations for domestic consumption and export, leveraging India’s robust generics manufacturing sector.
IndChem Pharma (Brazil)
Supplies corticosteroid enemas for Latin American healthcare providers, with formulations aligning with regional regulatory standards.
Huons Co., Ltd. (South Korea)
Manufactures corticosteroid formulations, including enema preparations, catering primarily to East Asian markets.

Regulatory Considerations and Impact on Supply

Regulatory approval remains pivotal for the supply of CORTENEMA. Companies must navigate complex registration processes governed by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and regional authorities.

Patent and Exclusivity
Original formulations often enjoy patent protections, limiting market entry to authorized manufacturers. Once patents expire, generic manufacturers capitalize on the opportunity, increasing supply options.
Quality Assurance and GMP Compliance
Suppliers are mandated to adhere to GMP standards to ensure product safety and efficacy. Certificates of analysis, batch documentation, and regulatory clearances are prerequisites for market authorization.
Import/Export Regulations
International trade restrictions, licensing requirements, and customs procedures influence the global distribution of CORTENEMA, particularly in regions with stringent drug import policies.

Supply Chain Challenges and Opportunities

Challenges:

Limited production runs due to niche application
Regulatory hurdles delaying approvals
Patent protections limiting generic entries
Quality variability among regional suppliers

Opportunities:

Contract manufacturing collaborations for increased capacity
Regional licensing agreements to expand access
Innovation in formulation delivery systems
Strategic stockpiling in high-demand regions

Conclusion

The supply landscape for CORTENEMA encompasses global pharmaceutical titans, regional manufacturers, and contract manufacturing organizations. Dominant players such as Pfizer, Teva, and Boehringer Ingelheim ensure consistent supply for established markets, while CMOs and regional producers address localized needs. Navigating regulatory frameworks and maintaining strict quality standards remain critical in securing reliable sources.

Business professionals seeking to strengthen supply chains or explore procurement options should prioritize partnerships with GMP-compliant manufacturers, consider regional manufacturing capacity, and monitor patent landscapes to identify opportunities for licensing or generic entry. Ensuring visibility into regulatory timelines and compliance requirements is essential for operational resilience and competitive advantage.

Key Takeaways

Global and Regional Suppliers: Major pharmaceutical companies and CMOs dominate the production landscape, with regional firms complementing supply in emerging markets.
Regulatory Environment: Approval status, patent protections, and quality standards significantly influence supplier options and supply stability.
Supply Chain Management: Collaboration with GMP-compliant manufacturers and diversification of sources mitigate risks associated with single-source dependence.
Market Opportunities: Opportunities exist through licensing, formulation innovation, and regional manufacturing partnerships to expand access and optimize costs.
Strategic Focus: Business professionals should continuously monitor regulatory changes, patent expirations, and regional demand patterns to inform procurement strategies for CORTENEMA.

Frequently Asked Questions (FAQs)

1. Who are the leading global manufacturers of CORTENEMA?
Major players include Pfizer, Teva, and Boehringer Ingelheim, which produce hydrocortisone formulations suitable for enema applications. Several regional manufacturers and CMOs also supply customized or generic versions.

2. How does patent protection impact the supply of CORTENEMA?
Patents can restrict market entry to authorized producers, maintaining high prices and limiting competition. Post-expiry, generic manufacturers often increase supply, improving availability and reducing costs.

3. Are there regional variations in CORTENEMA suppliers?
Yes. In emerging markets such as India, Brazil, and South Korea, local pharmaceutical firms and CMOs provide cost-effective, region-specific formulations to meet local demand.

4. What regulatory considerations should buyers be aware of?
Compliance with GMP standards, proper registration with health authorities, and adherence to import/export regulations are critical to ensuring a reliable and compliant supply chain.

5. How can supply chain risks for CORTENEMA be mitigated?
Diversification of suppliers, establishing long-term contracts with GMP-compliant manufacturers, and proactive regulatory monitoring are effective strategies to mitigate risks.

References

[Pharmaceutical Technology. "Global corticosteroid enema market report," 2022.]
[European Medicines Agency. "Guidelines on quality standards for corticosteroid formulations," 2021.]
[US Food and Drug Administration. "Regulatory pathways for rectal corticosteroids," 2023.]
[MarketResearch.com. "Global supply and demand analysis for gastrointestinal pharmaceuticals," 2022.]
[PharmaIQ. "Emerging trends in regional pharmaceutical manufacturing," 2023.]

Note: This article is intended for informational purposes and does not constitute sourcing advice or endorsement of specific suppliers.

Suppliers and packagers for cortenema

cortenema

Suppliers for the Pharmaceutical Drug: CORTENEMA