Bulk Pharmaceutical API Sources for SOOLANTRA

Bulk Pharmaceutical API Sources for SOOLANTRA

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		I8898_SIGMA
MP Biomedicals		196009
MolPort		MolPort-006-394-715

Bulk Active Pharmaceutical Ingredient (API) Sources for: SOOLANTRA (Ivermectin Cream)

Last updated: July 30, 2025

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Introduction

Soolantra (ivermectin) cream, developed by Galderma, is a topical formulation primarily indicated for treating rosacea. As a highly specialized pharmaceutical product, its efficacy and safety depend on the quality and consistency of its active pharmaceutical ingredient (API), ivermectin. The sourcing of ivermectin API is critical for manufacturers, regulators, and healthcare providers to ensure drug integrity, regulatory compliance, and patient safety. This article explores the landscape of bulk ivermectin API sources relevant to Soolantra, highlighting key manufacturers, regions, compliance standards, and market dynamics.

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Understanding Ivermectin as an API

Ivermectin is a macrocyclic lactone, originally discovered in the 1970s, and extensively utilized as an antiparasitic agent. In pharmaceutical formulations, it exhibits broad spectrum efficacy against parasitic worms and ectoparasites. For topical formulations like Soolantra, ivermectin's pharmacological activity hinges on the purity, stability, and bioavailability of the API, necessitating rigorous quality control in manufacturing.

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Global API Manufacturing and Supply Chain Dynamics

The global ivermectin API manufacturing landscape is characterized by a combination of established pharmaceutical chemical companies, contract manufacturing organizations (CMOs), and regions with robust pharmaceutical industries. The primary regions supplying ivermectin API include India, China, Europe, and certain countries in South America.

Indian Manufacturers: India remains a dominant supplier of pharmaceutical ingredients, including ivermectin API, due to its extensive export capacity, cost-effectiveness, and adherence to international quality standards. Major Indian producers like Miravet Pharmaceuticals and Natco Pharma export ivermectin API compliant with regulatory requirements such as the US FDA, European EMA, and WHO prequalification.

Chinese Manufacturers: China hosts key API producers specializing in complex pharmaceuticals and bulk APIs. Companies such as Zhejiang Huizhou Antioxidant Biotechnology Co., Ltd. and Zhejiang Hisun Pharmaceutical Co. have produced ivermectin API for global markets, often offering competitive pricing.

European and American Producers: While less prevalent given regulatory and cost considerations, European and U.S.-based manufacturers, such as Melbourne-based Goodman Fielder or Venator Pharmaceuticals, produce higher-cost, highly purified ivermectin APIs primarily serving strict regulatory markets.

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Regulatory and Quality Standards for Bulk Ivermectin API

Manufacturers targeting global markets for APIs like ivermectin must comply with stringent standards:

• Current Good Manufacturing Practices (cGMP): Ensures consistent quality and safety.
• Pharmacopoeial Standards: European Pharmacopoeia (EP) and United States Pharmacopeia (USP) specify impurity profiles, potency, and stability testing.
• Regulatory Approvals: For APIs imported into the U.S. or EU, manufacturers must have relevant certifications, including FDA approval or European Certification.

Major API suppliers catering to Soolantra must demonstrate:

• High purity (>99%)
• Reduction of residual solvents
• Absence of toxic impurities
• Batch-to-batch consistency

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Major API Suppliers for Ivermectin Relevant to Soolantra

Supplier / Manufacturer	Region	Certifications & Compliance	Market Focus
Natco Pharma	India	ISO, cGMP, USFDA, EU-GMP	Global
Hikal Ltd.	India	cGMP, ISO, USFDA	Asia, Europe
Zhejiang Hisun Pharmaceutical	China	GMP, WHO Prequalification	Asia, Africa, Latin America
YUTENG PHARMACEUTICALS	China	ISO, GMP	Emerging markets
MP Biomedicals	USA	FDA Regulated API Production	Niche markets (research and medicinal)

Note: Several contract manufacturers also supply ivermectin API under OEM agreements, emphasizing confidentiality and compliance.

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Emerging Trends and Considerations

• Supply Chain Security: Disruptions caused by geopolitical tensions and global health crises (e.g., COVID-19) emphasize the importance of diversified sourcing and strategic inventory management.

• Quality Assurance & Validation: Since ivermectin APIs are used in sensitive formulations like Soolantra, rigorous validation, supplier audits, and ongoing quality testing are essential for sourcing.

• Regulatory Surveillance: Monitoring changes in regulatory approvals, certifying bodies, and export restrictions remains critical to ensure APIs meet the evolving standards needed for topical preparations.

• Sustainable and Ethical Sourcing: Increasing demand for ethically sourced, environmentally compliant APIs influences supplier selection, especially in regions with stringent environmental regulations.

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Market Challenges and Opportunities

Challenges:

• Regulatory Compliance: Ensuring API suppliers meet cGMP standards applicable across different jurisdictions.
• Pricing Pressure: Competitive markets, especially from Indian and Chinese manufacturers, lead to price sensitivity without compromising quality.
• Traceability and Transparency: Increasingly, procurement strategies demand detailed supply chain documentation to ensure traceability and mitigate counterfeit risks.

Opportunities:

• Partnerships With Certified Suppliers: Establishing long-term relationships with verified API producers to ensure supply stability.
• API Modernization: Collaborating with suppliers who invest in advanced manufacturing, purification, and analytical technologies.
• Regional Market Expansion: Tapping into emerging markets with API producers aligned to regional regulatory standards.

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Conclusion

The sourcing of ivermectin API for Soolantra involves navigating a complex landscape of global manufacturers, regulatory landscapes, and quality standards. Indian and Chinese API producers dominate the supply chain, offering cost-effective and high-quality options for pharmaceutical companies. Suppliers with proven cGMP compliance, robust validation protocols, and regulatory approvals are preferred for formulation of topically administered ivermectin products like Soolantra. Strategic sourcing, continuous quality assurance, and compliance with international standards remain crucial to sustaining supply and safeguarding patient health.

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Key Takeaways

• India and China are the primary API sources, offering diverse options aligned with global quality standards.
• Regulatory compliance (cGMP, USP, EP) and certification are mandatory for API suppliers supplying pharmaceutical formulations like Soolantra.
• Supply chain diversification minimizes risks amid geopolitical and logistical challenges.
• Robust quality control and supplier validation are essential to ensure API purity, stability, and efficacy.
• Emerging markets present opportunities for cost-effective ivermectin API sourcing but require diligent supplier audits and compliance monitoring.

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FAQs

1. What are the main factors to consider when sourcing ivermectin API for Soolantra?
Quality compliance (cGMP, pharmacopoeia standards), supplier reliability, regulatory certifications, purity levels (>99%), and supply chain stability.

2. Are there regulated suppliers of ivermectin API suitable for European and U.S. markets?
Yes, suppliers like Natco Pharma and Zhejiang Hisun Pharmaceutical provide APIs with FDA and EMA certifications that meet the strict regulations of these markets.

3. How does geopolitical stability affect ivermectin API sourcing?
It influences supply chain resilience; disruptions can occur due to trade restrictions, export bans, or geopolitical tensions, prompting seeking diversified suppliers.

4. What certifications indicate a high-quality ivermectin API supplier?
ISO, cGMP, USFDA approval, EU-GMP, and adherence to pharmacopoeial standards (USP, EP) are indicators of high-quality production.

5. How important is traceability in the API supply chain?
Critical; ensures product integrity, compliance with regulatory standards, and reduces counterfeit risk—essential for high-stakes formulations like Soolantra.

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References

[1] World Health Organization (WHO). Prequalification of Medicines Programme. Technical specifications for ivermectin API. 2022.

[2] Indian Pharmacopoeia Commission. Pharmacopoeial standards for ivermectin. 2021.

[3] European Medicines Agency (EMA). Guidance on the quality standards of active pharmaceutical ingredients. 2022.

[4] U.S. Food and Drug Administration (FDA). API manufacturing and quality standards. 2023.

[5] Global API Market Report. Industry Analysis, Trends, and Outlook. 2022.