Suppliers and packagers for KENALOG-10

KENALOG-10

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apothecon	KENALOG-10	triamcinolone acetonide	INJECTABLE;INJECTION	012041	NDA	E.R. Squibb & Sons, L.L.C.	0003-0494-20	1 VIAL, MULTI-DOSE in 1 CARTON (0003-0494-20) / 5 mL in 1 VIAL, MULTI-DOSE	2009-06-01
Apothecon	KENALOG-10	triamcinolone acetonide	INJECTABLE;INJECTION	012041	NDA	A-S Medication Solutions	50090-0295-1	1 VIAL, MULTI-DOSE in 1 CARTON (50090-0295-1) / 5 mL in 1 VIAL, MULTI-DOSE	2009-06-01

Suppliers for the Pharmaceutical Drug: Kenalog-10

Last updated: August 8, 2025

Introduction

Kenalog-10, a corticosteroid injectable medication, is widely used for treating allergic reactions, arthritis, and other inflammatory conditions. Its active ingredient, triamcinolone acetonide, suppresses immune responses and reduces inflammation. Given its clinical significance, understanding the landscape of suppliers for Kenalog-10 is crucial for manufacturers, healthcare providers, and regulatory bodies aiming to ensure supply chain security, quality assurance, and cost management.

Global Manufacturing Landscape

Kenalog-10 is primarily manufactured by established pharmaceutical companies with robust steroid production capabilities. The supply chain is concentrated among a few key players, primarily based in North America, Europe, and Asia.

Major Suppliers

1. Pharmaceutical Industry Leaders

Eli Lilly and Company – The original developer of Kenalog-10, Eli Lilly has historically been the primary supplier of the drug. The company's manufacturing facilities in the United States and Europe continue to produce and distribute the medication globally. Eli Lilly maintains strict quality controls and regulatory compliance, ensuring high standards for medical use.

Bristol-Myers Squibb – Although not a primary manufacturer of Kenalog-10, BMS has engaged in licensing agreements and regional distribution partnerships for corticosteroid formulations, including Kenalog-10 in specific markets.

Mylan (now part of Viatris) – Known for producing generic formulations, Mylan has been a significant supplier of triamcinolone acetonide injections comparable to Kenalog-10. Their global manufacturing footprint supports widespread distribution, especially in developing markets.

Sandoz (a Novartis division) – Sandoz produces and supplies generic corticosteroid injections, often paralleling the formulation of Kenalog-10. Their manufacturing standards in Europe and North America ensure regulatory compliance.

2. Regional and Generic Manufacturers

In addition to the original patent holders, several regional and generic manufacturers supply Kenalog-10 or equivalent formulations:

• Lek Pharmaceuticals (Slovenia) – Sells generic corticosteroid injections aligned with Kenalog-10 standards.
• Pfizer – Has been involved in corticosteroid generation and distribution, particularly in Asian markets.
• Watsons Pharmaceuticals – Operates in select Asian markets and supplies generic corticosteroid injections.

Regulatory and Licensing Considerations

While Eli Lilly's patent for Kenalog-10 expired in many jurisdictions, regulatory evidence required for manufacturing and distribution varies by country. Generic manufacturers must obtain approval from local health authorities such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or equivalent agencies in other markets.

Quality Assurance and Standards

Suppliers must adhere to Good Manufacturing Practice (GMP) standards under the supervision of relevant regulatory authorities. Differences in manufacturing processes can impact the bioavailability, potency, and safety of Kenalog-10 formulations, necessitating rigorous quality verification, especially from generic manufacturers.

Market Dynamics and Supply Chain Risks

The supply of Kenalog-10 faces vulnerabilities due to regional manufacturing restrictions, regulatory delays, and geopolitical factors. The consolidation among major suppliers, particularly Eli Lilly's dominant position, centralizes supply but also introduces risks related to manufacturing disruptions.

COVID-19 pandemic disruptions highlighted vulnerabilities in global pharmaceutical supply chains, emphasizing the need for diversified sourcing, local manufacturing capacity, and strategic stockpiling.

Emerging Suppliers and Alternatives

Recent advances in biopharmaceutical manufacturing and increased demand for corticosteroids have prompted new entrants into the supply chain, including Chinese pharmaceutical firms expanding their sterile injectable corticosteroids portfolio. Companies like Qilu Pharmaceutical are emerging as regional suppliers, aiming to offer cost-effective alternatives.

However, these suppliers must demonstrate compliance with international GMP standards and obtain necessary regulatory approvals for global distribution.

Intellectual Property and Patent Landscape

While initial patents for Kenalog-10 have expired or been barred in many jurisdictions, some formulations or manufacturing processes may still be under patent protection or proprietary rights. This influences the licensing and partnership opportunities for suppliers and limits certain market entries.

Conclusion

The supply landscape for Kenalog-10 revolves around a mix of proprietary manufacturers, such as Eli Lilly, and a broader base of generic drug producers. The market's concentrated nature emphasizes the importance of diversifying sources, ensuring regulatory compliance, and maintaining high manufacturing standards to safeguard steady supply. As global demand persists, especially amid supply chain uncertainties, strategic procurement and supplier evaluation remain imperative for stakeholders.

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Key Takeaways

• Dominant Manufacturer: Eli Lilly is the primary supplier of Kenalog-10, with a legacy of quality manufacturing and global distribution.
• Generic Suppliers: Several regional producers, including Mylan, Sandoz, and Lek Pharmaceuticals, supply generic formulations aligned with Kenalog-10 standards.
• Regulatory Compliance: Suppliers must adhere to GMP standards and secure regulatory approval in target markets.
• Supply Chain Risks: Concentration among top producers heightens vulnerability; diversified sourcing is advisable.
• Emerging Markets: Chinese firms like Qilu are expanding their corticosteroid injectable production, potentially influencing future supply dynamics.

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FAQs

1. Who are the leading suppliers of Kenalog-10 globally?
Eli Lilly remains the primary supplier, supported by generic manufacturers like Mylan, Sandoz, and regional players in Europe and Asia.

2. Are generic versions of Kenalog-10 widely available?
Yes, multiple generic manufacturers produce corticosteroid injections similar to Kenalog-10. Regulatory approval and quality standards vary by country.

3. What factors influence the quality of Kenalog-10 supplied by different manufacturers?
Manufacturing standards, adherence to GMP, regional regulatory oversight, and quality control processes determine the quality of supplied Kenalog-10.

4. How has the COVID-19 pandemic impacted the supply of Kenalog-10?
Pandemic-related disruptions highlighted vulnerabilities due to supply chain concentration, prompting increased interest in local manufacturing and alternative suppliers.

5. What are the regulatory challenges for new entrants intending to supply Kenalog-10?
New suppliers must navigate complex approval processes, demonstrate GMP compliance, and secure licensing rights where applicable.

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Sources:
[1] Eli Lilly Official Website, "Kenalog (triamcinolone acetonide) Injectable," 2023.
[2] FDA Drug Approvals and Regulatory Filings.
[3] European Medicines Agency (EMA) Pharmacovigilance Data.
[4] Pharmaceutical Supply Chain Reports, IQVIA.
[5] Industry Expert Analyses on Corticosteroid Market Dynamics.