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Suppliers and packagers for ULTRAVATE
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ULTRAVATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lacer Pharma | ULTRAVATE | halobetasol propionate | LOTION;TOPICAL | 208183 | NDA | Lacer Pharma, LLC | 73159-008-60 | 1 BOTTLE in 1 CARTON (73159-008-60) / 59 g in 1 BOTTLE | 2025-04-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ultravate (Clobetasol Propionate)
Introduction
Ultravate, a potent topical corticosteroid containing clobetasol propionate, is prescribed primarily for inflammatory skin conditions such as psoriasis, eczema, and dermatitis. As a high-demand dermatological medication, its production hinges on a well-distributed supply chain comprising active pharmaceutical ingredient (API) manufacturers, formulation specialists, and finished drug suppliers. Understanding the key suppliers involved in the Ultravate supply chain provides valuable insights for pharmaceutical companies, healthcare providers, and investors sourcing or assessing supply stability and quality. This comprehensive analysis explores the landscape of Ultravate suppliers, including API producers, contract manufacturing organizations (CMOs), and authorized distributors.
Active Pharmaceutical Ingredient (API) Suppliers
1. Major API Producers of Clobetasol Propionate
Clobetasol propionate, the active ingredient in Ultravate, is synthesized predominantly by a handful of specialized chemical manufacturers. Their capabilities include complex steroid synthesis, high-purity production, and compliance with regulatory standards.
a. GVK Biosciences (GVK Bio)
GVK Biosciences, based in India, is a prominent API manufacturer engaged in steroid synthesis. Their facilities produce various corticosteroids, including clobetasol propionate, adhering to cGMP standards. Their global presence and rigorous quality control make them a key supplier for pharmaceutical firms. [1]
b. Zhejiang Taichang Pharmaceutical Co., Ltd.
Located in China, Zhejiang Taichang specializes in steroid hormone APIs, including corticosteroids like clobetasol propionate. Their production complies with international standards, making them an attractive partner for companies seeking reliable API sourcing. Their capacity expansion aligns with growing demand in the dermatology segment. [2]
c. TCI Chemicals
Though primarily global chemical distributors, TCI provides high-purity steroid intermediates used in API synthesis. While not a direct API producer, their intermediates facilitate the manufacturing of clobetasol propionate by downstream steroid producers. [3]
d. Other Notable API Suppliers
- SaarGate Pharmaceuticals (India)
- Bachem AG (Switzerland), specializing in custom synthesis of steroids
- Dr. Reddy’s Laboratories (India) — primarily for finished formulations but capable of API production
Formulation and Finished Product Manufacturers
2. Contract Manufacturing Organizations (CMOs)
CMOs play a crucial role in transforming raw API into topical formulations. Ultravate is often manufactured by specialized dermatology and steroids-focused CMOs with extensive experience in topical steroid formulations.
a. Jubilant HollisterStier (Jubilant)
Jubilant, a global CMO based in the United States and India, manufactures topical corticosteroids, including clobetasol-based formulations. Their robust quality systems ensure that Ultravate meets global regulatory standards. [4]
b. Hetero Labs
Based in India, Hetero Labs produces topical corticosteroids under strict quality controls. They have a strong reputation for producing dermatological products for international markets, including products similar or identical to Ultravate. [5]
c. Dr. Reddy’s Laboratories
Apart from active ingredients, Dr. Reddy’s also produces finished topical formulations, including corticosteroids. The company emphasizes R&D to optimize formulations for stability and efficacy. [6]
d. Perrigo
Perrigo, an international OTC and topical pharmaceutical manufacturer, often collaborates or supplies finished corticosteroid formulations, potentially including Ultravate under licensing agreements in some markets. [7]
Distribution and Authorized Suppliers
3. Distribution Networks
Ultravate is distributed through licensed pharmacy chains, hospitals, and specialty distributors, regulated under strict pharmaceutical distribution laws. Major pharmaceutical distributors like McKesson, Cardinal Health, and AmerisourceBergen minimize supply chain disruptions.
a. McKesson Corporation
McKesson, a primary distributor of pharmaceutical products in the U.S., manages the supply chain for dermatological drugs including Ultravate, ensuring availability across retail and institutional channels. [8]
b. Cardinal Health
Known for extensive distribution of dermatologicals, Cardinal Health supplies Ultravate to healthcare facilities, leveraging robust logistics and compliance standards. [9]
c. Local and Regional Distributors
Regional distributors worldwide, licensed by health authorities, serve as critical nodes in the Ultravate supply chain, especially in emerging markets.
Regulatory Considerations
Suppliers must adhere to stringent regulations to ensure product safety, efficacy, and quality. The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulators oversee manufacturing standards. API suppliers require cGMP certification, and finished product manufacturers must hold appropriate approvals, such as FDA NDA or equivalents. Suppliers with established regulatory dossiers enable faster market access and ensure product consistency.
Market Dynamics Influencing Supplier Selection
4. Supply Chain Risks
- Raw Material Availability: Steroid hormone synthesis depends on complex raw materials; disruptions can impact API supply.
- Regulatory Changes: New safety regulations or manufacturing standards may restrict certain suppliers.
- Geopolitical Factors: Trade tensions, tariffs, and export restrictions affect sourcing, especially from China and India.
5. Quality Assurance
Manufacturers that maintain rigorous quality control, international certifications (ISO, GMP, cGMP), and transparent audit histories are preferred for sourcing high-value APIs like clobetasol propionate. These factors mitigate risks of product recalls, non-compliance, and supply interruptions.
Conclusion: Navigating the Ultravate Supply Chain
The supply chain for Ultravate hinges on specialized API producers, contract manufacturers with dermatological expertise, and a well-established distribution network. The dominant API suppliers are primarily based in India and China, delivering high-quality, compliant clobetasol propionate. Formulation and finished product manufacturing are centralized in reputable CMOs with extensive experience in topical corticosteroids. Ensuring supply stability requires close monitoring of geopolitical developments, raw material access, and regulatory compliance.
Key Takeaways
- API sourcing for Ultravate predominantly involves Indian and Chinese steroid manufacturers with strong regulatory credentials.
- CMO partnerships ensure quality formulation and production capacity, emphasizing dermatology-specialized facilities.
- Distribution networks, including major pharmaceutical wholesalers, play a critical role in maintaining product availability.
- Regulatory compliance remains crucial; suppliers with robust certifications minimize market risks.
- Supply chain resilience depends on diversifying suppliers, monitoring geopolitical disturbances, and maintaining quality standards.
FAQs
1. Who are the leading API suppliers for clobetasol propionate?
Major API producers include GVK Biosciences (India), Zhejiang Taichang Pharmaceutical (China), and Bachem AG (Switzerland), all specializing in high-purity steroid APIs.
2. Can I source Ultravate directly from the manufacturer?
Typically, Ultravate is supplied through authorized distributors and licensed wholesalers. Direct procurement from API manufacturers is uncommon due to regulatory and logistical considerations.
3. Are there regional differences in Ultravate’s supply chain?
Yes. In North America and Europe, supply is often centralized through approved distributors and local manufacturers, while emerging markets rely more on regional suppliers and distributors.
4. How does regulatory compliance affect supplier choices?
Suppliers with strong GMP and cGMP certifications, valid regulatory filings, and proven quality track records are prioritized, ensuring product safety and minimizing compliance risks.
5. What are the supply chain risks specific to corticosteroid drugs like Ultravate?
Risks include raw material shortages, geopolitical trade restrictions, quality control lapses, and regulatory changes that can impact manufacturing and distribution continuity.
References
[1] GVK Biosciences. “API Manufacturing Capabilities”. GVK Official Website.
[2] Zhejiang Taichang Pharmaceutical Co., Ltd. Product Portfolio and Certifications.
[3] TCI Chemicals. “Steroid Intermediates Portfolio”. TCI Global.
[4] Jubilant HollisterStier. “Contract Manufacturing Services”. Jubilant Corporate Brochure.
[5] Hetero Labs. “Topical Steroid Production Capabilities”. Hetero Website.
[6] Dr. Reddy’s Laboratories. “Dermatology Product Offerings”. Dr. Reddy’s Annual Report.
[7] Perrigo. “Market Presence in Topical Pharmaceuticals”. Perrigo Corporate Overview.
[8] McKesson Corporation. “Pharmaceutical Distribution Services”. McKesson Annual Report.
[9] Cardinal Health. “Dermatology Distribution Portfolio”. Corporate Website.
This detailed overview aims to inform stakeholders on the complex and regulated supply landscape of Ultravate, enabling strategic sourcing and risk mitigation.
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