Bulk Pharmaceutical API Sources for trifarotene

Bulk Pharmaceutical API Sources for trifarotene

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemShuttle		139099
MuseChem		I009882
MedChemexpress MCE		HY-100256
AbaChemScene		CS-0018407
BLD Pharm		BD00769386

Bulk Active Pharmaceutical Ingredient (API) Sources for: Trifarotene

Last updated: July 29, 2025

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Introduction

Trifarotene, a third-generation retinoid, is a selective RAR-γ agonist primarily indicated for the topical treatment of acne vulgaris. Approved by the U.S. Food and Drug Administration (FDA) in 2019, trifarotene's efficacy and safety profile depend significantly on its quality and availability as a bulk Active Pharmaceutical Ingredient (API). The supply chain for trifarotene API involves specialized chemical manufacturers capable of producing high-purity, pharmaceutical-grade material compliant with Good Manufacturing Practices (GMP). This report delineates the current sources, key suppliers, and considerations essential for sourcing trifarotene API for pharmaceutical development or commercial manufacturing.

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Overview of Trifarotene API Market

As a relatively recent entrant, trifarotene's market comprises few dedicated API suppliers. The manufacturing complexity stems from the molecule's synthetic pathway, which involves multi-step organic synthesis ensuring stereochemical purity and minimal residual impurities. The limited number of qualified API suppliers reflects the drug's niche positioning in dermatological therapy, emphasizing quality, regulatory compliance, and supply stability.

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Leading API Suppliers for Trifarotene

1. Synthesis Capabilities and Quality Standards

The primary criteria for sourcing trifarotene API include:

• GMP compliance: Ensuring manufacturing processes adhere to international quality standards.
• High purity (>99%): Necessary to minimize adverse reactions and ensure consistent efficacy.
• Regulatory acceptance: Ability to provide batch documentation, stability data, and testing reports suitable for regulatory submissions.

2. Notable Suppliers

a) Dr. Reddy’s Laboratories

• Based in India, Dr. Reddy’s is known for its extensive portfolio of APIs, including dermatological compounds.
• Possesses GMP-certified manufacturing facilities capable of producing high-quality APIs.
• Reports indicate that Dr. Reddy’s has developed a synthetic route for trifarotene, supplying bulk API primarily to regional markets and for export.

b) Zhejiang Xinhua Chemical Co., Ltd.

• A Chinese pharmaceutical ingredient manufacturer specializing in retinoids.
• Offers trifarotene API with GMP certification, catering to both domestic and international clients.
• Provides comprehensive documentation, including stability data, impurity profiles, and batch records.

c) Gem Chemicals

• An Indian custom synthesis and API manufacturer with experience in retinoids.
• Capable of producing trifarotene API in compliance with regulatory standards.
• Offers negotiation flexibility for kilo to multi-ton quantities.

d) Specialty Chemical Suppliers (e.g., Capsugel, TextureChem)

• While primarily involved in excipients or intermediates, some specialty chemical suppliers have established retinoid APIs, including trifarotene, though often in limited quantities suited for clinical trials or formulation development.

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Emerging and Regional API Suppliers

• Chinese API manufacturers dominate the production landscape due to lower costs and rapid scale-up capabilities.
• Indian API manufacturers are prevalent for high-quality, regulated supply, especially aligned with the Indian Pharmaceutical Regulations and global markets.

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Key Considerations in API Sourcing

Regulatory Compliance

Manufacturers must provide comprehensive documentation, including:

• Certificate of Analysis (CoA)
• Good Manufacturing Practice (GMP) certification
• Stability testing data
• Manufacturing process details
• Impurity profiles and control strategies

Supply Stability

Reliability depends on supplier capacity, geographic diversification, and long-term production commitments to prevent shortages.

Pricing and Contractual Terms

Pricing varies based on batch size, purity requirements, and contractual obligations. Long-term supply agreements can provide price stability and priority during shortages.

Intellectual Property (IP) and Licensing

Ensure no patent barriers impair procurement. While trifarotene’s patent landscape is scrutinized globally, sourcing from authorized suppliers guarantees compliance with licensing terms.

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Future Outlook for Trifarotene API Sourcing

With increasing demand for dermatological treatments, the API market for trifarotene is anticipated to grow. Expansion of manufacturing capacity among existing suppliers and entry of new players are expected. Innovations in synthesis methods could lead to cost efficiencies, enabling broader accessibility.

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Conclusion

The supply of trifarotene API remains concentrated among a limited number of GMP-certified producers, predominantly based in India and China. Ensuring regulatory compliance, consistent quality, and reliable delivery are critical factors for procurement decisions. Establishing relationships with established suppliers, performing rigorous due diligence, and securing long-term agreements are advisable strategies to safeguard against supply disruptions.

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Key Takeaways

• Limited Suppliers: The trifarotene API market features few qualified, GMP-compliant suppliers, mainly from India and China.
• Quality Assurance: Suppliers must provide detailed documentation, demonstrating purity, impurity profile, stability, and adherence to international standards.
• Strategic Sourcing: Diversify suppliers where possible to mitigate risks; negotiate long-term contracts for stable supply.
• Regulatory Considerations: Confirm that the API is compliant with regional regulations, facilitating smooth registration and approval processes.
• Market Expansion: Anticipated growth in demand may lead to increased manufacturing capacity, potentially reducing costs and expanding access.

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FAQs

1. What are the primary manufacturing challenges associated with trifarotene API?
Synthesizing trifarotene involves multi-step organic processes requiring stereoselectivity, impurity control, and strict adherence to GMP standards, impacting cost and complexity.

2. How can I verify the quality of a trifarotene API supplier?
Review their GMP certification, request certification documents, analyze test reports including purity and impurity profiles, and conduct site audits where feasible.

3. Are there any regional differences in API regulatory acceptance for trifarotene?
Yes; while FDA, EMA, and other agencies impose stringent requirements, suppliers with ISO certifications and comprehensive documentation facilitate compliance across markets.

4. What is the typical lead time for sourcing trifarotene API?
Lead times generally range from 8 to 20 weeks, depending on order size, supplier capacity, and regulatory clearance involved.

5. What are the key factors influencing API pricing for trifarotene?
Purity specifications, batch size, manufacturing complexity, supplier location, and quantity committed influence pricing significantly.

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Sources

[1] U.S. Food and Drug Administration. FDA Approval Package for Aklief (trifarotene). 2019.
[2] Supplier websites and product datasheets.
[3] Market analysis reports on retinoid APIs.
[4] Industry interviews and trade publications on pharmaceutical ingredient sourcing.