Suppliers and packagers for SOOLANTRA

SOOLANTRA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255	NDA	Galderma Laboratories, L.P.	0299-3823-00	2 g in 1 TUBE (0299-3823-00)	2015-01-01
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255	NDA	Galderma Laboratories, L.P.	0299-3823-02	1 TUBE in 1 BLISTER PACK (0299-3823-02) / 2 g in 1 TUBE	2015-01-01
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255	NDA	Galderma Laboratories, L.P.	0299-3823-30	1 TUBE in 1 CARTON (0299-3823-30) / 30 g in 1 TUBE	2015-01-01
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255	NDA	Galderma Laboratories, L.P.	0299-3823-45	1 TUBE in 1 CARTON (0299-3823-45) / 45 g in 1 TUBE	2015-01-01

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: SOOLANTRA

Introduction

SOOLANTRA (ivermectin) topical cream 1%) is a prescription medication primarily indicated for the treatment of rosacea, specifically for inflammatory lesions such as papules and pustules. Developed by Galderma, SOOLANTRA has become a recognized treatment option in dermatology owing to its targeted efficacy and favorable safety profile. For pharmaceutical firms, healthcare providers, and distribution channels seeking to understand the supply landscape, identifying key suppliers and manufacturers of SOOLANTRA is essential. This report provides a comprehensive overview of the primary suppliers, manufacturing dynamics, and strategic considerations within the SOOLANTRA supply chain.

Manufacturers and Production Origins

Galderma’s Role and Manufacturing Facilities
Galderma, a global dermatology-focused pharmaceutical company headquartered in Switzerland, is the original developer and manufacturer of SOOLANTRA. The company owns underlying patents and has established manufacturing facilities dedicated to producing the cream at multiple locations worldwide. Galderma’s manufacturing sites in France, the United States, and other regions ensure global supply capacity, enabling delivery to various markets effectively.

Contract Manufacturing and Outsourcing
In addition to direct manufacturing, Galderma collaborates with third-party contract manufacturing organizations (CMOs) to augment production. These partnerships optimize capacity, reduce costs, and ensure regulatory compliance across different markets. Notable CMOs in the pharmaceutical sector—such as Catalent, Patheon (a part of Thermo Fisher Scientific), and Siegfried Holding AG—are likely involved in the supply chain. These entities provide formulation, fill-finish, and packaging services, thereby expanding supply flexibility amid fluctuating demand.

Key Suppliers in the Supply Chain

Active Pharmaceutical Ingredient (API) Suppliers
The core component of SOOLANTRA, ivermectin, is sourced from specialized API manufacturers. The global ivermectin market comprises several prominent suppliers:

• DSM Fine Chemicals (Netherlands): A leading supplier of ivermectin API with extensive regulatory approvals. DSM's high-purity ivermectin is utilized in various pharmaceutical applications, including dermatological formulations.
• Yunnan Rilin Pharmaceutical (China): A significant producer of ivermectin API, serving international markets with competitive pricing and quality standards comparable to Western suppliers.
• Guangzhou. Hongyao Pharmaceutical Co. (China): Emerging as a notable API producer, expanding access and competitive options.

Formulation and Finished Product Suppliers
While Galderma is the primary manufacturer, regional distributors and licensed generics can access SOOLANTRA through authorized supply channels. However, owing to patent protections and regulatory exclusivities, generic formulations are limited unless patent rights expire or licensing agreements are established.

Distribution and Regional Suppliers

Distribution Networks
Post-manufacturing, SOOLANTRA is distributed via authorized pharmaceutical distributors, wholesalers, and pharmacy chains globally. Major distribution players include McKesson, Cardinal Health, and IQVIA, which facilitate widespread availability in North America and Europe. Regional distributors in Asia-Pacific, Latin America, and Africa often partner with local pharmacies and healthcare providers to ensure access in emerging markets.

Supply Chain Challenges and Considerations

• Regulatory Approvals: Suppliers must adhere to stringent Good Manufacturing Practices (GMP) and obtain approvals from agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or regional regulators, which influence supply stability.
• Patent and Exclusivity Impacts: Patent protection for SOOLANTRA limits generic competition until expiration, influencing supply options and price dynamics.
• COVID-19 Pandemic Disruption: Global manufacturing and logistics disruptions have temporarily impacted supply chains, emphasizing the importance of diversified sourcing strategies.

Emerging and Future Suppliers

Market Entry of Generics
Once patent exclusivity expires, multiple generic manufacturers will likely emerge, increasing competition and potentially diversifying the supply chain. Companies such as Sandoz, Teva, and other generic producers show interest in ivermectin-based formulations, including topical creams.

Supply Chain Resilience Strategies
Pharmaceutical companies and regional distributors are increasingly diversifying suppliers, engaging multiple API producers, and establishing regional manufacturing hubs to mitigate supply risks. Strategic partnerships with Chinese and Indian API producers are likely to deepen, driven by competitive pricing and scalable production capacity.

Strategic Implications for Stakeholders

• Pharmaceutics firms should monitor patent expirations and emerging generic competition for long-term supply security.
• Distributors must develop relationships with multiple API suppliers to ensure uninterrupted supply and mitigate geopolitical or regulatory risks.
• Regulatory bodies influence the supply landscape through approvals, import restrictions, and quality assurance standards.

Conclusion

The supply landscape for SOOLANTRA is characterized by a combination of original manufacturing by Galderma, supplemented by third-party contract manufacturing, and a geographically diverse IPS (API suppliers). The current reliance on a few key API providers, primarily in Europe and China, underscores the importance of strategic sourcing and supply chain resilience. As patent protections expire, the emergence of generic producers will diversify supply sources, potentially reducing costs and expanding access globally. Understanding these dynamics is vital for stakeholders aiming to optimize procurement strategies, ensure regulatory compliance, and maintain market competitiveness.

Key Takeaways

• Primary manufacturers: Galderma remains the dominant producer, leveraging internal facilities and third-party CMOs.
• Core API suppliers: DSM (Netherlands) and Chinese manufacturers like Yunnan Rilin are leading ivermectin sources, with quality aligned to international standards.
• Distribution channels: Global distribution networks facilitate broad access, with regional partners filling local market needs.
• Market dynamics: Patent protections currently limit generic competition; future patent expirations will reshape supply options.
• Resilience strategies: Diversification of API sources and regional manufacturing hubs are critical for supply chain stability amid geopolitical and pandemic-related disruptions.

FAQs

Q1: Who are the primary manufacturers of SOOLANTRA?
A1: Galderma is the original developer and manufacturer, utilizing facilities in Switzerland, France, and the U.S., supplemented by partnerships with contract manufacturing organizations.

Q2: Which API suppliers provide ivermectin for SOOLANTRA?
A2: Major API suppliers include DSM (Netherlands), Yunnan Rilin Pharmaceutical (China), and other Chinese producers that meet international quality standards.

Q3: Are there generic versions of SOOLANTRA available?
A3: Not yet, due to patent protections; generics are expected to emerge once patent exclusivity expires, increasing competition and supply options.

Q4: How does supply chain disruption affect SOOLANTRA availability?
A4: Disruptions in manufacturing, logistics, or regulatory delays can impact supply, making diversification of suppliers and regional manufacturing critical.

Q5: What should stakeholders do to ensure supply stability for SOOLANTRA?
A5: Engaging multiple API suppliers, establishing regional manufacturing partnerships, and monitoring patent and regulatory developments are key strategies.

References

[1] Galderma. (2023). SOOLANTRA (ivermectin) cream: Product profile.
[2] IQVIA. (2023). Global Pharmaceutical Distribution Networks.
[3] DSM. (2023). Corporate overview: Pharmaceutical ingredients.
[4] Yunnan Rilin Pharmaceutical. (2022). API production capabilities.
[5] U.S. FDA. (2022). Guidelines on Good Manufacturing Practices (GMP).