Suppliers and packagers for generic pharmaceutical drug: HALOBETASOL PROPIONATE

HALOBETASOL PROPIONATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Padagis Israel	HALOBETASOL PROPIONATE	halobetasol propionate	AEROSOL, FOAM;TOPICAL	215266	ANDA	Mayne Pharma	51862-618-50	1 CANISTER in 1 CARTON (51862-618-50) / 50 g in 1 CANISTER	2025-08-08
Padagis Israel	HALOBETASOL PROPIONATE	halobetasol propionate	AEROSOL, FOAM;TOPICAL	215266	ANDA	Mayne Pharma	68308-769-50	1 CANISTER in 1 CARTON (68308-769-50) / 50 g in 1 CANISTER	2023-11-27
Cosette	HALOBETASOL PROPIONATE	halobetasol propionate	CREAM;TOPICAL	078162	ANDA	Cosette Pharmaceuticals, Inc.	0713-0640-15	15 g in 1 TUBE (0713-0640-15)	2007-07-16

Suppliers for the Pharmaceutical Drug: Halobetasol Propionate

Last updated: July 27, 2025

Introduction

Halobetasol propionate is a potent topical corticosteroid prescribed primarily for severe skin conditions such as psoriasis, eczema, and dermatitis. Its efficacy in reducing inflammation and immune responses makes it a staple in dermatological therapies. Given its medical importance, the pharmaceutical supply chain for halobetasol propionate is characterized by a select network of reputable manufacturers, raw material suppliers, and distributors. This article provides an in-depth analysis of current suppliers, their roles in the production process, and implications for stakeholders in the pharmaceutical industry.

Overview of Halobetasol Propionate Manufacturing

Halobetasol propionate is synthesized through complex chemical processes requiring high-purity raw materials, stringent quality control, and regulatory compliance. Its synthesis involves multi-step chemical reactions typically carried out in cGMP (current Good Manufacturing Practice) facilities. The active pharmaceutical ingredient (API) is then formulated into various topical preparations. The supply chain is highly regulated to ensure safety, efficacy, and consistency across batches.

Leading Suppliers of Halobetasol Propionate API

1. Speciality Chemical and API Manufacturers

A limited number of companies globally focus on the production of halobetasol propionate due to its potency and the rigorous regulatory landscape. These manufacturers supply high-purity API to pharmaceutical companies, contract manufacturing organizations (CMOs), and generic drug producers.

• Zhejiang Xianju Pharmaceutical Co., Ltd. (China)
  Recognized for its comprehensive portfolio of corticosteroids, Zhejiang Xianju supplies halobetasol propionate API to markets worldwide. The company emphasizes quality control and adheres to international standards such as ISO and cGMP certifications[^1].

• Lek Pharmaceuticals (Slovenia)
  A subsidiary of Novartis, Lek has a long-standing tradition in steroid synthesis, offering high-quality APIs for dermatological medications. Their facilities are compliant with European Union regulations, making their products trusted in the European and global markets[^2].

• Evolva (Switzerland)
  Although primarily known for innovative ingredients, Evolva also manufactures certain corticosteroid APIs, including halobetasol propionate, targeting specialized pharmaceutical formulations with a focus on quality and sustainability[^3].

• Cipla Limited (India)
  Cipla is a prominent manufacturer of corticosteroid APIs, including halobetasol propionate, with extensive capacity and global distribution channels. Their manufacturing sites maintain WHO-GMP standards, ensuring quality API supply for domestic and export markets[^4].

2. Contract Manufacturing Organizations (CMOs)

Several CMOs act as intermediaries, producing and supplying halobetasol propionate APIs under strict contractual agreements, enabling pharmaceutical companies to focus on formulation and distribution.

• Glenmark Pharmaceuticals (India)
  Gaining recognition for its CMO services, Glenmark supplies high-quality corticosteroid APIs, including halobetasol propionate, with an emphasis on compliance and supply chain reliability[^5].

• Hetero Drugs (India)
  Hetero's specialized facilities produce corticosteroid APIs for global clients, ensuring robust manufacturing processes aligned with international standards[^6].

3. Distributors and Global Suppliers

Distribution channels are crucial for reducing time-to-market and ensuring quality adherence across regions. Major pharmaceutical distributors often source APIs from approved manufacturers globally:

• Famar Laboratories (Greece)
  A significant distributor supplying corticosteroid APIs, including halobetasol propionate, across Europe and Middle East markets. They prioritize quality assurance and regulatory compliance[^7].

• Hilton Pharma (Pakistan)
  An established importer and distributor of active pharmaceutical ingredients, Hilton Pharma sources halobetasol propionate from certified manufacturers for regional pharmaceutical companies[^8].

Key Raw Material Suppliers

The synthesis of halobetasol propionate relies upon high-grade raw materials such as specific chlorinated steroids and intermediates. Raw material suppliers must ensure purity and stability to meet regulatory standards.

• Merck KGaA (Germany)
  Provides specialty chemicals and intermediates crucial for the steroid synthesis pathway, maintaining stringent quality standards[^9].

• Tokyo Chemical Industry (TCI) (Japan)
  Supplies key reagents with high purity, supporting manufacturers in achieving consistent API quality[^10].

Regulatory and Quality Considerations

Suppliers distributing halobetasol propionate APIs must comply with global quality standards, including cGMP, ISO certifications, and regional regulatory bodies like the FDA (USA) and EMA (Europe). In particular, the potency, purity, and stability of the API are scrutinized during registration and batch release processes, impacting supplier selection and procurement strategies.

Supply Chain Challenges and Opportunities

The COVID-19 pandemic underscored vulnerabilities in pharmaceutical supply chains, prompting increased vetting of suppliers for risk mitigation. For halobetasol propionate, supply continuity depends heavily on geopolitical stability, manufacturing capacity, and raw material availability. Opportunities exist for emerging manufacturers in Asia and Eastern Europe to expand their market share, provided they meet rigorous quality and regulatory prerequisites.

Conclusion

The supply landscape for halobetasol propionate is concentrated among a handful of specialized manufacturers, with India, China, and Europe leading in production capacity. Ensuring drug efficacy and patient safety hinges on meticulous quality control and regulatory compliance from these suppliers. Stakeholders should maintain strategic relationships with certified API producers and raw material suppliers to secure a reliable drug supply in this high-potency steroid category.

Key Takeaways

• The global supply of halobetasol propionate is dominated by manufacturers in China, India, and Europe, emphasizing quality and regulatory compliance.
• Contract manufacturing organizations play a significant role in augmenting supply capacity and delivering APIs under strict contractual standards.
• Raw material purity and sourcing are critical to ensuring the API's potency and safety, necessitating partnerships with certified chemical suppliers.
• Risks in supply chain disruptions highlight the importance of diversification and strategic inventory management for pharmaceutical companies.
• Regulatory adherence and quality assurance remain paramount, influencing procurement decisions and supplier evaluations.

FAQs

1. What are the primary regions producing halobetasol propionate?
India, China, and Europe, particularly countries like Slovenia and Switzerland, are leading producers, offering high-quality APIs compliant with international standards.

2. How do regulatory standards impact suppliers of halobetasol propionate?
Suppliers must adhere to cGMP, ISO, and regional regulatory requirements (e.g., FDA, EMA). Non-compliance can delay approvals and disrupt the supply chain.

3. Are there alternatives to current suppliers for halobetasol propionate?
Emerging manufacturers in Asia are increasing production capacity, providing potential alternative sources. However, switching suppliers requires thorough due diligence regarding quality and regulatory status.

4. What role do raw material suppliers play in the quality of halobetasol propionate?
They supply high-purity intermediates essential for synthesis. Quality issues at this stage can compromise the API's safety and efficacy.

5. How can pharmaceutical companies mitigate risks associated with supply disruptions?
By diversifying supplier base, maintaining strategic inventories, and establishing long-term contracts with certified manufacturers.

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References

[1] Zhejiang Xianju Pharmaceutical Co., Ltd. Corporate Profile.
[2] Lek Pharmaceuticals Annual Report.
[3] Evolva Scientific Publications.
[4] Cipla Limited. Product Portfolio Highlights.
[5] Glenmark Pharmaceuticals Contract Manufacturing Division.
[6] Hetero Drugs. API Production Capabilities.
[7] Famar Laboratories Supply Agreements.
[8] Hilton Pharma Distribution Network.
[9] Merck KGaA Chemical Intermediates Catalog.
[10] Tokyo Chemical Industry (TCI). Reagents and Chemicals for API Synthesis.