SKLICE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Arbor Pharms Llc	SKLICE	ivermectin	LOTION;TOPICAL	202736	NDA	Azurity Pharmaceuticals	24338-185-04	1 TUBE in 1 CARTON (24338-185-04) / 117 g in 1 TUBE	2022-08-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Sklice (ivermectin lotion 0.5%) is a topical pharmaceutical product primarily used for the treatment of head lice infestation (pediculosis) in patients aged six months and older. Approved by the U.S. Food and Drug Administration (FDA) in 2012, Sklice is manufactured by Valeant Pharmaceuticals (now part of Bausch Health Companies Inc.) and has established a niche in the pediculicide market due to its unique formulation and mode of action. Understanding the supplier landscape for Sklice is crucial for pharmaceutical stakeholders, clinicians, and supply chain managers aiming to ensure consistent and reliable access to this medication.

Manufacturing and Key Suppliers of Sklice

1. Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals)

The primary manufacturer of Sklice is Bausch Health, which acquired the rights to the drug from Valeant Pharmaceuticals. Bausch Health oversees the entire supply chain, including R&D, manufacturing, distribution, and marketing of Sklice. The manufacturing process involves specialized formulation technologies designed to produce a stable, effective ivermectin lotion suited to a topical application.

Key aspects:

Manufacturing Facilities: Bausch Health operates manufacturing sites equipped with facilities compliant with Good Manufacturing Practices (GMP), ensuring quality control and regulatory adherence.
Raw Material Sourcing: Bausch procures raw ivermectin, the active pharmaceutical ingredient (API), from selected global suppliers with rigorous quality standards.

2. Sourcing of Ivermectin API

The core component of Sklice, ivermectin, is sourced globally from multiple API producers. Some of the notable suppliers include:

Mitsubishi Tanabe Pharma Corporation: A leading Japanese pharmaceutical company, Mitsubishi Tanabe produces ivermectin APIs for various formulations worldwide.
Korea United Pharm Inc.: Based in South Korea, this company supplies high-quality ivermectin APIs to several pharmaceutical firms.
Mikrogen (Germany): Specializes in producing pharmaceutical-grade APIs, including ivermectin, for global distribution.

Other API sources include generic manufacturers from India and China, which supply bulk ivermectin for topical formulations, often at competitive prices but with varying quality controls.

3. Contract Manufacturing Organizations (CMOs)

Bausch Health may employ CMOs for formulation, packaging, and distribution processes to meet production demands. Notable CMOs include:

Sandoz (Novartis): Known for their expertise in sterile and topical formulations, Sandoz may be involved in large-scale manufacturing or distribution.
Liangsu Hengrui Medicinal: Chinese CMO capable of GMP manufacturing for APIs and finished dosage forms.

As per regulatory disclosures, specific CMO partnerships are often confidential, but these organizations play a vital role in increasing manufacturing capacity and ensuring supply chain resilience.

Supply Chain Considerations and Challenges

1. Raw Material Availability

The sourcing of ivermectin API from multiple global suppliers helps mitigate supply disruptions. However, the COVID-19 pandemic caused shortages of certain raw materials, highlighting vulnerabilities in the supply chain. Regulatory agencies have urged diversified sourcing strategies.

2. Regulatory Compliance

Manufacturers and suppliers must adhere to strict GMP standards enforced by the FDA, EMA, and other regulatory bodies. Any deviation can delay or halt supply.

3. Geopolitical Factors

Trade restrictions, tariffs, and geopolitical tensions involving China, India, and South Korea can influence API availability and pricing.

4. Market Demand and Production Capacity

A surge in lice infestations or increased awareness can lead to higher demand, requiring scaling manufacturing capabilities. Bausch Health’s global production facilities are reinforced to meet such fluctuations.

Emerging Suppliers and Market Dynamics

While Bausch Health remains the sole marketer and primary manufacturer of Sklice, the broader ivermectin market features numerous generic manufacturers, primarily in India and China, producing API and finished formulations. These suppliers focus on off-label uses or similar antiparasitic products, but Sklice’s proprietary formulation and regulatory approval limit direct competition.

The potential for new entrants hinges on:

Regulatory approval processes for generic versions of Sklice.
Patent protections that Bausch Health maintains over the formulation.
Manufacturing capacity expansion aligned with market demand.

Conclusion

The supply landscape for Sklice is predominantly controlled by Bausch Health, with raw ivermectin API supplied by various international entities, including Mitsubishi Tanabe Pharma, Korean and Chinese API producers, and European AP providers. The complex global supply chain necessitates vigilant management to avoid disruptions caused by raw material shortages, regulatory bottlenecks, or geopolitical influences. As the demand for effective pediculicides persists, ongoing diversification of API sources and manufacturing partnerships will be critical to ensuring steady availability of Sklice.

Key Takeaways

Primary manufacturer: Bausch Health, overseeing the production, formulation, and distribution of Sklice.
API sourcing: Multiple global suppliers (Japan, South Korea, Europe, India, China) provide ivermectin APIs, ensuring supply flexibility.
Supply chain risks: Raw material shortages, regulatory compliance, and geopolitical factors can impact supply reliability.
Market outlook: Potential for generic development and manufacturing capacity expansion to meet rising demand.
Strategic importance: Consistent, high-quality supplier relationships are essential for supply chain resilience and market competitiveness.

FAQs

1. Who are the main suppliers of ivermectin active pharmaceutical ingredient (API) for Sklice?
Major API suppliers include Mitsubishi Tanabe Pharma (Japan), Korea United Pharm Inc. (South Korea), and various Indian and Chinese manufacturers, all adhering to GMP standards for pharmaceutical quality.

2. Can other companies produce generic versions of Sklice?
While the active ingredient ivermectin is available from various generic manufacturers, Sklice’s proprietary topical formulation and patent protections currently limit the approval and commercialization of generic versions.

3. How does Bausch Health ensure supply chain resilience?
By diversifying API sources, utilizing multiple manufacturing facilities, and maintaining regulatory compliance, Bausch Health mitigates risks of supply disruptions.

4. Are there geopolitical risks affecting Sklice's supply?
Yes; trade tensions involving China, India, and South Korea can influence API availability and prices, making supply diversification vital.

5. What factors influence the pricing of Sklice?
Pricing depends on raw material costs, manufacturing capacity, regulatory compliance costs, market demand, and competition from generic alternatives.

Sources

U.S. Food and Drug Administration (FDA). Sklice (ivermectin lotion) approval documentation. https://www.accessdata.fda.gov
Bausch Health Annual Reports. Corporate disclosures on manufacturing and supply chain details.
Mitsubishi Tanabe Pharma Corporation. Product and API supply information.
Market analysis reports on global ivermectin supply chain (published 2022–2023).
World Health Organization (WHO). Guide to pharmaceutical API manufacturing standards.

Suppliers and packagers for SKLICE

SKLICE

Suppliers for the Pharmaceutical Drug: Sklice (Ivermectin Lotion)