halobetasol propionate; tazarotene: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354	NDA	Bausch Health US, LLC	0187-0653-01	1 TUBE in 1 CARTON (0187-0653-01) / 100 g in 1 TUBE	2019-04-25
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354	NDA	Bausch Health US, LLC	0187-0653-03	6 TUBE in 1 CARTON (0187-0653-03) / 3 g in 1 TUBE	2019-04-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape for dermatological treatments heavily relies on the availability of high-quality active pharmaceutical ingredients (APIs). Among these, Halobetasol Propionate—a potent topical corticosteroid—and Tazarotene—a retinoid used in acne and psoriasis management—are critical components prescribed globally. Their supply chains involve a diverse array of suppliers ranging from multinational API manufacturers to specialized chemical producers. This article provides a comprehensive overview of the key suppliers for these APIs, emphasizing global manufacturing hubs, regulatory considerations, and market dynamics crucial for stakeholders in pharmaceutical procurement, manufacturing, and R&D.

Halobetasol Propionate: Overview and Supplier Landscape

Pharmacological Profile

Halobetasol Propionate is classified as a super-potent topical corticosteroid, widely prescribed for inflammatory skin conditions, including psoriasis and eczema. Due to its potency and strict regulatory requirements, suppliers must adhere to rigorous quality standards, including Good Manufacturing Practices (GMP) and stringent analytical control.

Major Global Suppliers

BASF SE (Germany)

BASF is a leading global chemical manufacturer with significant expertise in producing corticosteroid APIs. They offer high-quality Halobetasol Propionate, supported by robust R&D and manufacturing facilities in Europe and North America [1].
Synthesis and Contract Manufacturing Organizations (CMOs)

Several CMOs—such as Harker BioPharma (India), LGM Pharma (U.S.), and Lupin Limited (India)—manufacture Halobetasol Propionate on behalf of brand owners and generic drug companies. These organizations often operate under strict GMP compliance and serve regional markets.
Dr. Reddy’s Laboratories (India)

As a major pharmaceutical company with extensive APIs portfolio, Dr. Reddy’s supplies Halobetasol Propionate to both domestic and international markets, emphasizing cost-efficiency and quality control [2].
Jiangsu Heben Pharmacy (China)

Chinese manufacturers like Jiangsu Heben Pharmacy have increased production capacity for corticosteroids, including Halobetasol Propionate, catering primarily to Asian markets but expanding globally.
Other Notable Suppliers
- Fagron (Belgium): Provides compounded formulations utilizing high-grade corticosteroid APIs.
- Synthesis-oriented Indian firms such as Glenmark and Sun Pharma.

Regulatory and Supply Chain Considerations

Supply continuity depends heavily on compliance with global regulatory standards: FDA (U.S.), EMA (Europe), and CDSCO (India). Manufacturers obtaining certifications such as WHO-GMP or PIC/S adherence ensure better market access.

Tazarotene: Overview and Supplier Landscape

Pharmacological Profile

Tazarotene, a topical retinoid, is essential in treating psoriasis and acne. Its chemical complexity necessitates precise synthetic pathways and quality assurance, with suppliers often possessing advanced organic synthesis capabilities.

Key Suppliers

TEVA Pharmaceuticals (Israel)

A dominant player globally, TEVA manufactures Tazarotene with high purity, serving both its proprietary products and licensing agreements for generics [3].
Mitsubishi Tanabe Pharma Corporation (Japan)

Specializing in dermatological agents, Mitsubishi produces Tazarotene for regional markets in Asia and exports globally, emphasizing high stability and efficacy standards.
Synthesis and Contract Manufacturers in India

Indian firms such as Aurobindo Pharma and Cipla have developed synthetic routes for Tazarotene and commercialized the API for domestic and export markets, aligning with global regulatory protocols.
Chinese API Producers

Companies like Hengbao Group and Peptek Pharma have scaled production of Tazarotene, predominantly targeting Asian markets, but increasingly supplying to international clients following regulatory approvals [4].
Other Noteworthy Suppliers
- Hikal Ltd. (India): Focuses on synthetic retinoids and derivatives, including Tazarotene.
- Zhejiang Hisun Pharmaceutical (China): Engages in generic API production.

Regulatory and Quality Considerations

Suppliers comply with international standards, often securing certifications like ISO, GMP, and in some cases, EMA approval for exported products. The complexity of synthesis and stability of Tazarotene makes quality assurance a priority for procurement.

Market Dynamics and Supply Chain Challenges

The supply of Halobetasol Propionate and Tazarotene is influenced by several macroeconomic and regulatory factors:

Regulatory Stringency: Stringent approval processes by FDA and EMA influence supplier quality assurance and impede counterfeit infiltration.
Raw Material Availability: The synthesis of these APIs depends on specialized chemical precursors, which are subject to geopolitical and trade dynamics.
Manufacturing Concentration: A handful of large manufacturers dominate, risking supply disruptions due to geopolitical tensions or manufacturing issues.
Cost Pressures: Emerging generic manufacturers in India and China are driven by cost advantages but face challenges maintaining regulatory compliance.
Patent and Exclusivity Status: Patent expirations for Tazarotene have increased the number of generic suppliers, expanding options and stabilizing supplies.

Conclusion

Supply chains for Halobetasol Propionate and Tazarotene are characterized by a mixture of established multinational manufacturers and agile regional producers. The key to securing reliable sourcing lies in partnering with suppliers adhering to global quality standards and maintaining transparency in manufacturing practices. Increasing regulatory oversight and geopolitical considerations underscore the importance of strategic supplier diversification.

Key Takeaways

Diverse Supplier Base: Major suppliers include BASF, TEVA, Dr. Reddy’s, and Indian and Chinese manufacturers, ensuring some stability but necessitating risk management strategies.
Quality and Regulatory Compliance: GMP certifications and adherence to international standards are critical for supply security.
Market Dynamics: Patent expiries and regulatory approvals influence the number of suppliers and market competition, particularly for Tazarotene.
Supply Chain Risks: Geopolitical issues, raw material access, and manufacturing disruptions pose ongoing challenges.
Strategic Sourcing: Companies should maintain an active supplier landscape, including regional and global manufacturers, to mitigate risks and ensure continuous access.

FAQs

1. Who are the leading suppliers of Halobetasol Propionate globally?
Leading suppliers include BASF (Germany), Dr. Reddy’s Laboratories (India), and Jiangsu Heben Pharmacy (China), among others. These companies adhere to high-quality standards aligned with global regulatory requirements.

2. Are there regional differences in the supply of Tazarotene?
Yes. TEVA and Mitsubishi dominate in developed markets, while Indian and Chinese manufacturers significantly supply Asia and emerging markets. Regulatory approvals influence regional supplier prominence.

3. What factors influence the choice of a supplier for these APIs?
Quality assurance, regulatory compliance, cost, manufacturing capacity, and supply stability are primary considerations.

4. How do patent statuses impact the supplier landscape for Tazarotene?
Patent expirations have opened the market to numerous generic manufacturers, increasing supply options and competitive pricing.

5. What are the risks associated with API supply chains for these drugs?
Risks include regulatory non-compliance, geopolitical tensions, raw material shortages, manufacturing disruptions, and counterfeit products.

References

[1] BASF SE Chemical Portfolio, 2023.
[2] Dr. Reddy’s Annual Report, 2022.
[3] TEVA Pharmaceuticals Product Pipeline, 2023.
[4] Indian Pharmaceutical Market Report, 2022.

Suppliers and packagers for generic pharmaceutical drug: halobetasol propionate; tazarotene