Bulk Pharmaceutical API Sources for KENALOG-10

Bulk Pharmaceutical API Sources for KENALOG-10

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-002-529-154
Hangzhou APIChem Technology		AC-1239
AKos Consulting & Solutions		AKOS015894871

Bulk Active Pharmaceutical Ingredient (API) Sources for: KENALOG-10

Last updated: July 30, 2025

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Introduction

Kenalog-10 (triamcinolone acetonide) is a potent synthetic corticosteroid used widely in dermatology, rheumatology, and other inflammatory conditions. Its efficacy hinges on the high-quality API ensuring consistent therapeutic outcomes. As pharmaceutical companies seek reliable sources for bulk APIs, understanding the landscape of suppliers for triamcinolone acetonide is vital. This article delineates key API manufacturing sources, evaluates their credibility, and provides insights pertinent for stakeholders planning procurement or strategic partnerships.

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Overview of Triamcinolone Acetonide API

Triamcinolone acetonide is characterized by its potent anti-inflammatory action, with an extensive clinical application profile. Its widespread manufacturing occurs predominantly in regions such as India, China, Italy, and the United States. The API's quality, regulatory compliance, and supply stability influence product quality and commercialization success.

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Major API Manufacturers for Triamcinolone Acetonide

1. Indian API Manufacturers

India remains a significant hub for corticosteroid API production, distinguished by cost advantages, robust manufacturing infrastructure, and regulatory compliance aligned with WHO-GMP standards.

• Macleods Pharmaceuticals

  • Overview: One of India's leading pharmaceutical exporters, Macleods has dedicated facilities for corticosteroids, including triamcinolone acetonide.
  • Capabilities: Fully integrated manufacturing with stringent quality assurance aligning with international standards.
  • Certifications: US FDA, EU GMP, and EDQM compliance attest to their quality control.

• Sun Pharmaceutical Industries Ltd.

  • Overview: Sun Pharma offers a comprehensive portfolio of corticosteroid APIs, including triamcinolone acetonide.
  • Quality Assurance: Known for high-quality manufacturing with certifications under US FDA and EMA.

• Glenmark Pharmaceuticals

  • Overview: Active in the corticosteroids market, Glenmark supplies bulk APIs compliant with global quality requirements.

2. Chinese API Manufacturers

China's API sector is notable for large-scale production, competitive pricing, and expanding regulatory adherence.

• Hubei Kangyuan Pharmaceutical Co., Ltd.

  • Profile: Specializes in corticosteroid APIs with exported quantities to various markets.
  • Compliance: Meets cGMP standards, with some facilities holding US FDA and EMA approvals.

• Shanghai Singh Chemical Co., Ltd.

  • Capacities: Offers triamcinolone acetonide with diverse specifications suitable for different formulations.
  • Certifications: Complies with international standards and provides documentation on quality.

3. European and US Manufacturers

While European and US-based APIs are less prevalent due to higher costs, some manufacturers and trading companies supply high-purity triamcinolone acetonide.

• Bachem AG (Switzerland)

  • Profile: Known for high-purity pharmaceutical ingredients, Bachem supplies specialty corticosteroid APIs, including triamcinolone acetonide, for research and clinical trial purposes.
  • Certifications: GMP, ISO standards, with rigorous quality controls.

• Halo Pharmaceutical and Other Distributors

  • Facilitates sourcing from registered Chinese or Indian manufacturers, ensuring batch consistency and compliance documentation.

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Sourcing Considerations

Regulatory Compliance and Certification

Ensuring API suppliers hold appropriate certifications (US FDA, EMA, cGMP, EDQM) is critical to avoiding regulatory setbacks. Suppliers with established quality management systems and transparent documentation mitigate cross-border importation risks.

Supply Stability and Lead Times

Given the global fluctuation in API demand and raw material availability, evaluating suppliers on their production capacity, inventory management, and lead times is essential.

Pricing and Cost-Effectiveness

While Indian and Chinese manufacturers often offer competitive prices, balancing cost with quality is vital. Engaging with suppliers offering detailed Certificate of Analysis (CoA), stability data, and compliance reports ensures reliable quality.

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Emerging Trends in API Sourcing

• Localized Production and Nearshoring: Some companies explore regional suppliers to reduce lead times and supply chain disruptions.
• Regulatory Convergence: Increasing harmonization of global standards encourages suppliers to upgrade facilities and obtain multiple certifications.
• Sustainable and Ethical Sourcing: Growing emphasis on environmentally sustainable practices influences supplier selection.

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Conclusion

The viability of Sourcing bulk triamcinolone acetonide API hinges on strategic evaluation of manufacturers, considering quality, compliance, cost, and supply chain robustness. Indian and Chinese suppliers dominate the landscape, with notable European and US players offering niche or high-purity options. Stakeholders should prioritize verified suppliers with strong regulatory backing to mitigate risks and ensure product excellence for KENALOG-10.

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Key Takeaways

• India and China are primary sources of bulk triamcinolone acetonide API, offering cost-effective solutions with growing regulatory compliance.
• Certification, Quality Assurance, and Regulatory Approvals are critical factors for supplier qualification.
• Establishing reliable partnerships with well-established manufacturers reduces supply chain risks.
• The evolving regulatory landscape emphasizes the importance of GMP-certified suppliers globally.
• Sustainability and ethical sourcing are increasingly influencing procurement decisions.

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FAQs

1. What are the main factors to consider when sourcing triamcinolone acetonide API?
Quality certifications (US FDA, EMA, cGMP), supplier reputation, supply chain stability, regulatory compliance, and cost.

2. Are Indian API manufacturers reliable sources for KENALOG-10?
Yes. Many Indian manufacturers like Macleods and Sun Pharma adhere to international standards and have extensive export experience.

3. How can I verify the quality of APIs from Chinese suppliers?
Request detailed Certificates of Analysis, audit the manufacturing facilities when possible, and verify certifications such as cGMP or equivalent.

4. Is high purity triamcinolone acetonide available from any US-based suppliers?
Yes, Bachem AG supplies high-purity APIs for research and clinical purposes, although mainstream commercial API supply is limited.

5. What impact do regional manufacturing regulations have on API sourcing?
Regulatory standards influence API quality and acceptance. Suppliers meeting stringent standards reduce regulatory hurdles for finished drug approval.

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References

[1] Datasheets and product catalogs from Macleods Pharmaceuticals, Sun Pharmaceutical Industries Ltd., Glenmark Pharmaceuticals.
[2] Industry reports on global corticosteroid API manufacturing, Pharmacopoeia standards (USP, EP, JP).
[3] Regulatory guidelines from US FDA, EMA, and EDQM.
[4] Market analysis articles on Chinese and Indian API sectors.