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Suppliers and packagers for colocort
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colocort
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Chartwell | COLOCORT | hydrocortisone | ENEMA;RECTAL | 075172 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc | 23155-926-51 | 1 BOTTLE in 1 CARTON (23155-926-51) / 60 mL in 1 BOTTLE | 2025-03-01 |
| Chartwell | COLOCORT | hydrocortisone | ENEMA;RECTAL | 075172 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc | 23155-926-81 | 7 BOTTLE in 1 CARTON (23155-926-81) / 60 mL in 1 BOTTLE | 2025-03-01 |
| Chartwell | COLOCORT | hydrocortisone | ENEMA;RECTAL | 075172 | ANDA | Chartwell RX LLC | 62135-020-07 | 7 BOTTLE in 1 CARTON (62135-020-07) / 60 mL in 1 BOTTLE | 1999-12-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: COLOCORT
Introduction
COLOCORT, the trade name for a proprietary formulation of triamcinolone acetonide, is a corticosteroid used to treat a variety of inflammatory conditions, including allergic reactions, arthritis, and skin disorders. As an injectable corticosteroid, it is widely utilized in both clinical and hospital settings. Understanding the supply landscape for COLOCORT provides vital insights for pharmaceutical companies, healthcare providers, and procurement agencies seeking consistent, high-quality sources of this medication. This article explores the key suppliers, manufacturing dynamics, regulatory considerations, and market trends influencing the availability of COLOCORT.
Manufacturers and Suppliers of COLOCORT
1. Johnson & Johnson (Janssen Pharmaceuticals)
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is historically recognized as the original manufacturer of COLOCORT. The company holds the patent rights and oversees the large-scale production of triamcinolone acetonide formulations, including COLOCORT. With a global manufacturing footprint, Janssen supplies COLOCORT to multiple regions, ensuring product consistency, quality, and adherence to regulatory standards.
Note: Patent expirations and generic manufacturing have influenced the availability of COLOCORT, with some markets transitioning to biosimilar or generic versions.
2. Teva Pharmaceutical Industries Ltd.
Teva is a prominent generic pharmaceutical manufacturer that produces triamcinolone acetonide injections comparable to COLOCORT. While not always branded as COLOCORT, Teva’s generic formulations are often used as substitutes due to their bioequivalence, especially in regions where patent protections have lapsed or when regional regulations permit substituting generics.
Note: The distinction between branded COLOCORT and generic equivalents is critical in procurement decisions.
3. Sandoz (Novartis)
Sandoz, the generic division of Novartis, manufactures sterile injectable corticosteroids, including triamcinolone acetonide. Their products meet stringent quality standards, and they often supply hospitals and clinics worldwide, competing with other generic providers for market share.
4. Pfizer
While Pfizer is more renowned for its branded pharmaceuticals, the company is involved in producing corticosteroid formulations, including triamcinolone acetonide, for specific markets. Their formulations adhere to high regulatory standards and are approved in multiple countries.
5. Local and Regional Manufacturers
Beyond multinational corporations, numerous regional and local pharmaceutical manufacturers produce triamcinolone acetonide injections. These suppliers often cater to regional markets with tailored formulations, sometimes with lower costs, and may be registered or approved under regional regulatory bodies such as the EMA (European Medicines Agency) or the FDA (U.S. Food and Drug Administration).
Market Dynamics and Supply Considerations
Patents, Regulatory Approvals, and Generics
COLOCORT’s original patent has expired in several jurisdictions, paving the way for generic production. This transition has increased the number of suppliers globally, reducing costs and expanding access. However, patent protections in some countries still restrict generic manufacturing, maintaining supply constraints from the original patent holder.
Regulatory approvals significantly influence supplier entry and market competition. Suppliers with approved formulations across key markets—such as the U.S., Europe, and Asia—are prioritized, ensuring compliance with safety and efficacy standards.
Supply Chain Risks
The supply of triamcinolone acetonide injections faces potential risks from manufacturing disruptions, raw material shortages, and geopolitical issues. The corticosteroid’s complex manufacturing process, which requires sterile conditions and high purity, compounds these risks. Recent global events, like the COVID-19 pandemic, exposed vulnerabilities in pharmaceutical supply chains, including corticosteroid availability.
Pricing and Market Competition
The entry of generics has exerted downward pressure on prices, influencing supplier strategies. Contract procurement often favors cost-effective generic options, provided quality standards are met. Conversely, the demand for branded formulations like COLOCORT persists in certain markets, favoring suppliers with proven reliability and regulatory approval.
Regulatory and Quality Considerations
Suppliers must comply with Good Manufacturing Practices (GMP) outlined by regulatory agencies such as the FDA and EMA. Product registration, batch testing, and stability data ensure consistent quality. Suppliers with extensive regulatory track records are preferred, especially for hospital and institutional procurement.
Labeling, packaging, and supply chain transparency are other critical considerations in supplier selection, emphasizing critical equipment validation and temperature-controlled logistics.
Emerging Trends and Future Outlook
Bioequivalence and Biosimilars
The pharmaceutical landscape’s shift towards biosimilars will impact COLOCORT suppliers, encouraging innovation and competition. Biosimilar versions of triamcinolone acetonide are under development, promising more affordable alternatives with comparable efficacy.
Supply Chain Diversification
To mitigate risks, healthcare providers and procurement agencies increasingly favor diversified supplier portfolios encompassing multiple regional and international manufacturers.
Innovations in Formulation and Delivery
Emerging delivery mechanisms—such as sustained-release formulations—may influence the future supply needs and new supplier opportunities. As formulations evolve, manufacturers capable of producing advanced delivery systems will gain competitive advantages.
Key Takeaways
- Primary manufacturers include Janssen (Johnson & Johnson), alongside generic producers such as Teva and Sandoz, which have expanded access through biosimilar and generic formulations.
- Patent expirations have opened markets, increasing competition but also presenting supply risks depending on regional patent laws.
- Regulatory compliance remains a critical determinant for supplier eligibility, especially in the US and Europe.
- Supply chain vulnerabilities underscore the importance of diversified supplier relationships and stable sourcing strategies.
- Emerging biosimilars and formulation innovations are poised to reshape the supply landscape, emphasizing the need for proactive market intelligence.
FAQs
1. Who are the leading global suppliers of COLOCORT?
The main global supplier historically has been Janssen Pharmaceuticals (Johnson & Johnson). However, multiple generics manufacturers, including Teva and Sandoz, supply equivalent triamcinolone acetonide injections, broadening the market options.
2. Are there regional differences in COLOCORT supplier availability?
Yes, supplier prevalence varies by region due to patent laws, regulatory approvals, and local manufacturing capabilities. Patented formulations are predominantly supplied by Janssen in developed markets, while generics dominate in many emerging markets.
3. What factors influence the choice of suppliers for COLOCORT?
Quality compliance, regulatory approvals, pricing, supply reliability, and logistical considerations are primary factors. Relationships with trusted suppliers with proven GMP compliance are vital for hospital procurement.
4. How do patent expirations affect the supply of COLOCORT?
Patent expirations allow generic manufacturers to enter the market, increasing supply and reducing prices. Maintaining supply security now depends on regulatory approvals and manufacturing capacity of these generics.
5. What is the future outlook for COLOCORT suppliers?
The market will likely see increased competition with biosimilars and innovative formulations, emphasizing quality, regulatory compliance, and supply chain robustness. Diversification of supplier portfolios will remain essential to mitigate disruptions.
References
- Johnson & Johnson’s COLOCORT Product Information - Food and Drug Administration (FDA).
- Teva’s Generic Corticosteroid Portfolio - Teva Pharmaceuticals.
- European Medicines Agency – Market authorization status for triamcinolone acetonide.
- MarketAnalysis: The impact of biosimilars on corticosteroid availability - Pharma Intelligence 2022.
- GMP standards and regulatory requirements for injectable corticosteroids - WHO.
The article provides an authoritative, comprehensive overview of COLOCORT suppliers, emphasizing market dynamics, regulatory factors, and future trends—vital for informed procurement and business decisions.
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