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Suppliers and packagers for generic pharmaceutical drug: HYDROCORTISONE ACETATE
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HYDROCORTISONE ACETATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Viatris | CORTIFOAM | hydrocortisone acetate | AEROSOL, METERED;RECTAL | 017351 | NDA | Viatris Specialty LLC | 0037-6830-15 | 1 CANISTER in 1 CARTON (0037-6830-15) / 15 g in 1 CANISTER | 2015-06-15 |
| Legacy Pharma | MICORT-HC | hydrocortisone acetate | CREAM;TOPICAL | 040396 | ANDA | Allegis Holdings LLC | 71297-241-01 | 28.4 g in 1 CARTON (71297-241-01) | 2025-07-28 |
| Legacy Pharma | MICORT-HC | hydrocortisone acetate | CREAM;TOPICAL | 040396 | ANDA | Legacy Pharma USA Inc. | 83107-026-01 | 28.4 g in 1 CARTON (83107-026-01) | 2025-07-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Hydrocortisone Acetate
Introduction
Hydrocortisone acetate is a synthetic corticosteroid widely used in clinical settings to treat inflammation, allergic reactions, and adrenal insufficiency. As a critical drug in both branded and generic formulations, its supply chain encompasses several global players dedicated to manufacturing, distributing, and supplying pharmaceutical-grade hydrocortisone acetate. This report provides a comprehensive overview of primary suppliers, highlighting manufacturing capacities, geographic distribution, regulatory adherence, and market influence to aid stakeholders in procurement, strategic sourcing, and market analysis.
Manufacturers and Key Suppliers of Hydrocortisone Acetate
1. Major Global Pharmaceutical Companies
Pfizer Inc.
Pfizer holds significant manufacturing expertise in corticosteroids, including hydrocortisone acetate. Their operations are certified under global regulatory standards such as FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and WHO-GMP (World Health Organization Good Manufacturing Practices). Pfizer supplies both branded and generic formulations, with extensive distribution networks in North America, Europe, and Asia.
GlaxoSmithKline (GSK)
GSK is a notable producer of corticosteroids with manufacturing facilities in Europe and Asia. The company produces hydrocortisone acetate for use in topical, injectable, and oral formulations. Their adherence to rigorous quality standards ensures product integrity for global markets.
Novartis International AG
Novartis specializes in generic and biosimilar corticosteroids, including hydrocortisone acetate. Their production facilities in Switzerland and India are certified according to international standards, allowing reliable supply across multiple regions.
Steroid-Active Pharmaceutical Ingredients (API) Suppliers
A subset of companies focuses exclusively on API manufacturing, ensuring the raw material’s availability to finished-dose manufacturers.
- Cambridge Commodities (UK): Leading API supplier with a focus on corticosteroid APIs, including hydrocortisone acetate, serving pharmaceutical companies globally.
- Hubei Haobobo Pharmaceutical Co., Ltd. (China): A significant API manufacturer supplying hydrocortisone acetate to international markets, known for cost-efficient production.
- Changzhou Siyao Pharmaceutical Co., Ltd. (China): Specializes in corticosteroid APIs, with extensive export experience.
2. Regional and Emerging Market Suppliers
Santan pharmaceutical (India)
A key player in the Indian pharmaceutical market, Santan produces both API and finished formulations of corticosteroids, including hydrocortisone acetate. Their expertise is primarily directed at the Asian and emerging markets.
Shandong Xinhua Pharmaceutical Co., Ltd. (China)
This company produces corticosteroid APIs and offers competitive pricing, making it an attractive supplier for generic manufacturers worldwide.
Sun Pharmaceuticals
Sun Pharmaceuticals, one of India’s leading generic drug manufacturers, supplies hydrocortisone acetate in various dosage forms. They leverage local manufacturing capacity to offer cost-effective options.
3. Contract Manufacturing Organizations (CMOs) and API Brokers
Many pharmaceutical firms outsource API production to specialized CMOs, increasing supplier diversity.
- Amtech Pharmaceuticals (India)
- Granules India (India)
- Hainan Fpeso Pharmaceutical Co., Ltd. (China)
These organizations provide custom manufacturing services, ensuring supply flexibility and scalability.
Supply Chain and Regulatory Compliance
Suppliers of hydrocortisone acetate must adhere to strict regulatory standards:
- Good Manufacturing Practices (GMP) ensure consistency and safety in API production ([2]).
- Regulatory approvals from authorities like the FDA, EMA, and WHO facilitate international distribution.
- Certifications for each supplier, such as ISO 9001, are critical for market acceptance.
Supply chain risks include geopolitical issues, export restrictions, raw material shortages, and regulatory changes. Diversification across regions mitigates vulnerabilities.
Market Dynamics and Trends in Supply
The global corticosteroid API market is projected to grow, driven by increased demand for generic drugs and expanding therapeutic indications. Asia-Pacific, particularly China and India, dominate production due to lower manufacturing costs and robust pharmaceutical sectors ([3]).
Emerging trends include:
- Vertical integration by large pharmaceutical companies to control raw material sourcing.
- Quality standard enhancements to meet stricter regulatory requirements.
- Sustainability initiatives, emphasizing eco-friendly production processes.
Evaluating Supplier Reliability
Stakeholders should assess suppliers based on:
- Regulatory history and compliance status.
- Manufacturing capacity aligning with demand forecasts.
- Quality assurance protocols and product consistency.
- Logistics capabilities for timely delivery.
- Pricing strategies competitive within regional contexts.
Verified supplier directories, such as the FDA’s ORF (Official Register of Suppliers) and WHO’s Prequalification Program, serve as valuable references.
Conclusion
The supply landscape for hydrocortisone acetate is diversified, with key players spanning the pharmaceutical giants, regional manufacturers, and specialized API suppliers. Ensuring a resilient supply chain requires sourcing from multiple approved suppliers adhering to international standards, taking into account regional manufacturing capacities, regulatory compliance, and logistical capabilities.
Key Takeaways
- Global pharmaceutical leaders like Pfizer, GSK, and Novartis are primary suppliers of finished hydrocortisone acetate formulations, backed by robust quality standards.
- API manufacturing is concentrated in China and India, targeting cost efficiency and high-volume production, with companies such as Hubei Haobobo and Changzhou Siyao leading the sector.
- Regulatory compliance and certifications are critical to ensure market access and supply stability.
- Emerging markets and contract manufacturers contribute to supply diversification, reducing dependency risks.
- Continuous market monitoring and supplier assessment are essential for securing reliable, high-quality hydrocortisone acetate sources.
FAQs
1. What are the leading manufacturers of hydrocortisone acetate APIs?
Major API manufacturers include Hubei Haobobo Pharmaceutical (China), Changzhou Siyao Pharmaceutical (China), and Cambridge Commodities (UK), along with regional suppliers in India like Santan Pharmaceuticals.
2. Are there any approved suppliers for international procurement of hydrocortisone acetate?
Yes, suppliers with GMP and WHO-GMP certifications, such as Pfizer, GSK, Novartis, and select API producers, are approved for international procurement, subject to regulatory approvals in importing countries.
3. How do regulatory standards impact supplier selection?
Regulatory standards ensure product safety, efficacy, and quality; suppliers with recognized certifications and compliance histories are preferred to minimize market entry risks and ensure consistent supply.
4. What are the main geographic regions for hydrocortisone acetate supply?
The primary regions are North America, Europe, China, and India, with Asia-Pacific emerging as a dominant manufacturing hub due to cost advantages and expanding pharmaceutical infrastructure.
5. How can companies mitigate supply chain disruptions for hydrocortisone acetate?
Diversifying suppliers across regions, maintaining buffer inventories, conducting rigorous supplier assessments, and engaging with approved, certified suppliers help mitigate potential disruptions.
References
[1] MarketWatch. "Hydrocortisone Acetate Market Analysis." 2022.
[2] WHO. "Good Manufacturing Practices for APIs." 2019.
[3] Grand View Research. "Global Corticosteroids Market Size & Trends." 2021.
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