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Suppliers and packagers for HYDROCORTISONE BUTYRATE
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HYDROCORTISONE BUTYRATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Taro Pharm Inds | HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | CREAM;TOPICAL | 076654 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4074-1 | 1 TUBE in 1 CARTON (51672-4074-1) / 15 g in 1 TUBE | 2005-08-04 |
| Taro Pharm Inds | HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | CREAM;TOPICAL | 076654 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4074-2 | 1 TUBE in 1 CARTON (51672-4074-2) / 30 g in 1 TUBE | 2005-08-04 |
| Taro Pharm Inds | HYDROCORTISONE BUTYRATE | hydrocortisone butyrate | CREAM;TOPICAL | 076654 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4074-5 | 5 g in 1 TUBE (51672-4074-5) | 2005-08-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Hydrocortisone Butyrate
Introduction
Hydrocortisone Butyrate, a potent topical corticosteroid, plays a significant role in managing inflammatory and allergic skin conditions. Its efficacy hinges on high-quality sourcing, which underscores the importance of understanding the landscape of suppliers capable of producing pharmaceutical-grade hydrocortisone butyrate. This article offers a comprehensive analysis of the primary suppliers, their geographic distribution, regulatory compliance, and strategic considerations vital for pharmaceutical companies’ sourcing decisions.
Overview of Hydrocortisone Butyrate
Hydrocortisone Butyrate (CAS No. 1874-84-6) belongs to the class of corticosteroids with anti-inflammatory, antipruritic, and vasoconstrictive properties. Due to its topical application specificity, manufacturers require suppliers that adhere to stringent pharmaceutical standards, including Good Manufacturing Practices (GMP). The global demand stems from dermatology, allergy treatment, and cosmetic sectors, amplifying the necessity for supply chain robustness.
Leading Suppliers of Hydrocortisone Butyrate
1. GlaxoSmithKline (GSK) and Patheon (Thermo Fisher Scientific)
While primarily recognized as pharmaceutical developers and contract manufacturing organizations (CMOs), GSK’s legacy manufacturing facilities and Thermo Fisher's contract services offer hydrocortisone derivatives, including butyrate forms. GSK’s extensive R&D and manufacturing infrastructure ensure high-quality standards, making them reliable partners for bulk production and custom synthesis.
2. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
Zhejiang Hisun Pharmaceutical, a major Chinese pharmaceutical manufacturer, produces a broad portfolio of corticosteroids, including hydrocortisone butyrate. Their facilities operate under GMP regulations, ensuring compliance with international standards, with supply agreements targeting both domestic and export markets.
3. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
This Chinese firm specializes in active pharmaceutical ingredients (APIs) and intermediates. Their hydrocortisone butyrate production line maintains certification aligned with European and US GMP standards, positioning them as key global suppliers, especially for Asian markets.
4. Hangzhou Minsheng Pharmaceutical Co., Ltd. (China)
Minsheng Pharmaceutical offers hydrocortisone butyrate with a focus on export-quality APIs. They have obtained international GMP certifications and supply to major generic pharmaceutical companies worldwide.
5. HEZUO PHARMACEUTICAL (China)
Specializing in corticosteroids, HEZUO produces high-purity hydrocortisone derivatives, including butyrate salts, exporting chiefly to North America and Europe.
Emerging and Notable European and North American Suppliers
While Chinese manufacturers dominate the bulk API market, European and North American firms have begun ramping up supply of hydrocortisone derivatives due to stricter regulatory environments and quality demands.
6. Mylan/Viatris (USA & India)
Viatris, formed from Mylan’s merger, produces corticosteroid APIs under rigorous GMP standards, including hydrocortisone butyrate, mainly for U.S. and European markets.
7. EuroAPI (France)
EuroAPI focuses on high-quality APIs for dermatological and corticosteroid drugs, offering hydrocortisone butyrate produced under \textbf{EU GMP} standards, suitable for pharmaceutical formulations requiring strict compliance.
8. Sandoz (Switzerland)
A Novartis division, Sandoz supplies corticosteroid APIs, including hydrocortisone derivatives, with a focus on biopharmaceutical-grade quality.
Supply Chain and Regulatory Considerations
The choice of supplier for hydrocortisone butyrate depends on multiple factors, including:
- Regulatory Compliance: Suppliers must demonstrate adherence to GMP for API production, with certifications from agencies such as the FDA, EMA, or corresponding authorities (e.g., China GMP, EU GMP).
- Quality Assurance: High purity, consistency, and reproducibility are non-negotiable for pharmaceutical use. Lot-to-lot consistency and detailed documentation are vital.
- Production Capacity: Suppliers must meet current and projected demand, especially considering global shortages or supply chain disruptions.
- Cost and Lead Time: Competitive pricing and reliable delivery schedules are key for maintaining profitability and minimizing stockouts.
- Traceability and Transparency: Proven supply chain traceability ensures authenticity and compliance with regulatory audits.
Strategic Recommendations for Buyers
For pharmaceutical companies sourcing hydrocortisone butyrate, establishing multi-source procurement strategies mitigates supply chain risks. Engaging with certified suppliers featuring robust quality management systems reduces compliance issues. Establishing long-term agreements may ensure priority access and better pricing. Additionally, performing due diligence, including site audits and review of regulatory records, enhances procurement security.
Future Market Trends
The demand for topical corticosteroids remains steady, bolstered by an aging global population and increased skin allergy awareness. Consequently, suppliers investing in capacity expansion, process innovation, and regulatory alignment will likely dominate the landscape. There is also an anticipated shift toward sourcing from manufacturers with proven compliance in the EU and North America, driven by stricter regulatory enforcement and quality expectations.
Key Takeaways
- The Chinese API manufacturing sector dominates the supply landscape for hydrocortisone butyrate due to large-scale capacity and cost advantages.
- European and North American suppliers, although limited, are preferred for formulations requiring high regulatory scrutiny, offering GMP and EU-GMP certified APIs.
- Strategic diversification of suppliers mitigates risks from geopolitical, regulatory, and supply chain disruptions.
- Thorough due diligence—covering certifications, quality records, and capacity—remains essential before engagement.
- As demand persists, suppliers investing in high-quality, compliant manufacturing will command a premium position, offering longer-term partnership opportunities.
FAQs
1. What are the primary factors to consider when selecting a hydrocortisone butyrate supplier?
Quality assurance (GMP compliance), regulatory certifications, capacity, price, lead times, and supply chain transparency are critical.
2. Are Chinese suppliers reliable for pharmaceutical-grade hydrocortisone butyrate?
Many Chinese manufacturers comply with international GMP standards, making them reliable sources when thoroughly vetted and certified. However, due diligence and qualification audits are advised.
3. How does regulatory compliance impact supplier choice?
Regulatory compliance ensures product safety, efficacy, and legal marketability. Suppliers with recognized GMP certifications and regulatory approvals reduce validation risks and streamline approval processes.
4. Is there a significant market difference between domestic and export-grade hydrocortisone butyrate?
Yes. Domestic-grade products may not meet international pharmaceutical standards, whereas suppliers with international GMP certifications serve global markets needing strict compliance.
5. What future developments could influence the hydrocortisone butyrate supply landscape?
Regulatory tightening, capacity investments, and emerging markets’ growth will influence supply chain dynamics, favoring suppliers who proactively adapt to evolving standards.
References
[1] International Agency for Research on Cancer. (2021). "Chemical Safety Data Sheets" for corticosteroids.
[2] MarketWatch. (2022). "Global Corticosteroid API Market Analysis and Industry Forecast."
[3] US Food and Drug Administration. (2022). "Guidelines for API Manufacturing."
[4] European Medicines Agency. (2022). "GMP Certification Guidelines."
[5] Chinese Pharmacopoeia. (2020). "Standards for Corticosteroid APIs."
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