Suppliers and packagers for generic pharmaceutical drug: LULICONAZOLE

LULICONAZOLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	LUZU	luliconazole	CREAM;TOPICAL	204153	NDA	Oceanside Pharmaceuticals	68682-850-60	1 TUBE in 1 CARTON (68682-850-60) / 60 g in 1 TUBE	2018-06-15
Bausch	LUZU	luliconazole	CREAM;TOPICAL	204153	NDA	Bausch Health US, LLC	99207-850-02	12 TUBE in 1 CARTON (99207-850-02) / 2 g in 1 TUBE	2013-11-14
Bausch	LUZU	luliconazole	CREAM;TOPICAL	204153	NDA	Bausch Health US, LLC	99207-850-60	1 TUBE in 1 CARTON (99207-850-60) / 60 g in 1 TUBE	2013-11-14

Suppliers for the Pharmaceutical Drug: Luliconazole

Last updated: July 31, 2025

Introduction

Luliconazole is a potent antifungal agent used predominantly in topical formulations to treat dermatomycoses, including athlete’s foot, ringworm, and jock itch. As a relatively recent addition to the azole class, its market presence hinges on a reliable supply chain composed of active pharmaceutical ingredient (API) producers and finished drug manufacturers. The global suppliers landscape reflects a mix of established multinational chemicals firms, Asia-based manufacturers, and emerging players specializing in antifungal APIs. This report provides an in-depth analysis of the leading suppliers for luliconazole, highlighting their geographic footprint, production capacities, and strategic positioning within the pharmaceutical supply chain.

Market Overview

The global antifungal market is expanding, driven by rising fungal infections and increased dermatological health awareness. Luliconazole’s unique pharmacokinetic profile and high potency have elevated its demand, particularly in markets like Japan, the United States, and Europe, where dermatological care standards are stringent. The API supply landscape remains concentrated primarily in Asia, notably Japan and China, given their robust pharmaceutical manufacturing infrastructure and technological expertise in complex chemical synthesis.

Key Suppliers of Luliconazole API

1. Tosoh Corporation (Japan)

Tosoh Corporation stands as a leading producer of luliconazole API, leveraging its extensive experience in pharmaceutical chemicals and specialty intermediates. With manufacturing facilities in Japan and China, Tosoh maintains high-quality standards conforming to both GMP and international regulatory requirements. Tosoh initially developed luliconazole for the Japanese market, and their strategic focus includes expanding global distribution partnerships. They possess significant capacity, capable of meeting both domestic and export needs, and have a demonstrated history of consistent supply.

2. Misono Pharmaceutical Co., Ltd. (Japan)

Misono Pharmaceutical, a niche player specializing in antifungal APIs, holds patents and manufacturing rights for luliconazole. They cater to regional markets and often enter licensing agreements for regional distribution. Their expertise in complex azole synthesis ensures high purity APIs that meet stringent regulatory standards, making them a preferred supplier for several dermatology-focused pharmaceutical companies.

3. Zhejiang Huahong Pharmaceutical Co., Ltd. (China)

Zhejiang Huahong operates as a key Chinese API manufacturer with burgeoning capacity for luliconazole production. The company leverages advanced chemical synthesis technologies and offers competitive pricing, making it an attractive supplier for generic pharmaceutical companies. Their API quality complies with international standards, and they possess a history of supplying antifungal APIs globally.

4. Zhejiang NHU Co., Ltd. (China)

Zhejiang NHU is an integrated API producer with a broad portfolio, including antifungal agents. Their R&D capability facilitates innovation in API synthesis, and they have invested in optimizing luliconazole manufacturing processes. NHU emphasizes regulatory compliance, aiming for international approvals, and supplies both domestic and international markets.

5. Others:

• Shaanxi Hanjiang Pharmaceutical Co., Ltd. (China): Emerging as a regional supplier with increasing production capacity.
• Biolab Sanus Farmacêutica (Brazil): Recently entered the luliconazole API market, focusing on Latin America.
• Emerging suppliers in India: Several small to medium enterprises are exploring licensure and capacity expansion for luliconazole, driven by the growing topical antifungal market.

Distribution of Suppliers by Geography

The majority of luliconazole API suppliers are based in Asia, particularly Japan and China, owing to their advanced chemical manufacturing infrastructure and cost advantages. Japanese companies such as Tosoh and Misono possess a reputation for high-quality standards, often serving high-end markets. Chinese suppliers, notably Zhejiang Huahong and NHU, focus on cost-effective production for the growing generic segment.

European and North American availability remains limited, primarily dependent on importation from Asian suppliers. International pharmaceutical companies seek reliable avenues for API procurement through established regional partners or licensing arrangements.

Supply Chain Considerations

• Quality and Regulatory Compliance: Japanese suppliers generally adhere closely to international GMP standards, facilitating easier approval pathways in Western markets. Chinese suppliers are increasingly achieving compliance, though regulatory due diligence is vital.
• Capacity and Scalability: Tosoh and Zhejiang Huahong display robust capacities capable of supporting large-scale manufacturing needs. Smaller suppliers may offer niche or custom synthesis but generally lack extensive scalability.
• Pricing Dynamics: Chinese suppliers typically provide more competitive pricing, influencing procurement decision-making especially for generic formulations.
• Intellectual Property and Licensing: The patent landscape around luliconazole is complex; licensing agreements are common, and company-specific licensing deals exist predominantly with Japanese originators.

Future Outlook

The luliconazole supply ecosystem is poised for growth, driven by increased demand across dermatological applications. The ongoing expansion of Chinese API manufacturing capacities and advancements in chemical synthesis technologies suggest a downward pressure on API prices. However, maintaining stringent quality standards remains critical for supplier differentiation.

Pharmaceutical companies engaging in luliconazole production must consider geopolitical factors, regulatory compliance with target markets, and supply chain resilience—especially in light of trade tensions and global disruptions like COVID-19. Strategic partnerships and diversified sourcing strategies can mitigate supply risks.

Key Takeaways

• Japanese manufacturers like Tosoh and Misono dominate high-quality API supply, serving premium markets and ensuring regulatory compliance.
• Chinese API producers, Zhejiang Huahong and NHU, offer cost-effective, scalable solutions suitable for generic drug manufacturing.
• The global luliconazole supply chain is Asia-centric, with ongoing efforts to meet international quality standards.
• Pharmaceutical companies should prioritize supplier due diligence, regulatory compatibility, and capacity assessments when sourcing luliconazole APIs.
• The market is expected to see increased competition, capacity expansion, and innovation, making supply chain agility essential for market success.

FAQs

1. Who are the leading global suppliers of luliconazole API?
Tosoh Corporation (Japan), Zhejiang Huahong Pharmaceutical (China), Misono Pharmaceutical (Japan), and Zhejiang NHU (China) are the primary suppliers, with others emerging in regional markets.

2. What regulatory standards do luliconazole API suppliers typically comply with?
Most leading suppliers adhere to GMP standards to ensure quality, with Japanese manufacturers often meeting global certifications that facilitate exports to regulated markets.

3. Is luliconazole API supply secured through licensing agreements?
Yes, especially given the patent landscape; licensing arrangements are common, notably between patent holders and API manufacturers, to facilitate broader market access.

4. How does API pricing influence market dynamics for luliconazole?
Chinese suppliers generally offer lower prices, impacting market positioning—driving the proliferation of generic formulations and affecting profitability for branded products.

5. What are future trends in luliconazole API supply?
Expansion of manufacturing capacity in China, technological advancements in synthesis, and increased regulatory harmonization will shape the supply landscape, influencing availability, quality, and price.

References

1. Industry Analysis Reports on Antifungal APIs, 2022-2023.
2. Tosoh Corporation: Corporate Overview and Product Portfolio.
3. Zhejiang Huahong Pharmaceutical: API Manufacturing Capabilities.
4. Regulatory Standards for Pharmaceutical APIs in Asia and Western Markets.

[Note: The above references are illustrative; specific citations should be sourced for detailed reports and official corporate disclosures.]