Suppliers and packagers for generic pharmaceutical drug: TRIFAROTENE

TRIFAROTENE

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	AKLIEF	trifarotene	CREAM;TOPICAL	211527	NDA	Galderma Laboratories, L.P.	0299-5935-02	1 TUBE in 1 BLISTER PACK (0299-5935-02) / 2 g in 1 TUBE	2019-10-04
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527	NDA	Galderma Laboratories, L.P.	0299-5935-45	1 BOTTLE, PUMP in 1 CARTON (0299-5935-45) / 45 g in 1 BOTTLE, PUMP	2019-10-04

Suppliers for the Pharmaceutical Drug: Trifarotene

Last updated: July 29, 2025

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Introduction

Trifarotene is a topical retinoid primarily indicated for the treatment of acne vulgaris. As a selective retinoic acid receptor gamma (RARγ) agonist, it offers targeted therapy with an improved safety profile compared to earlier-generation retinoids. Its unique mechanism and clinical efficacy have increased global demand, prompting a diverse array of suppliers spanning gene pharmaceuticals, generics manufacturers, and specialty chemical companies. This article consolidates existing supplier landscape information, emphasizing manufacturing sources, licensing agreements, and regional distribution channels critical for stakeholders.

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Manufacturing Landscape for Trifarotene

1. Original Developer and Patent Holders

The initial development and commercialisation of trifarotene were led by Galderma, a global dermatology-focused pharmaceutical firm [1]. Galderma's proprietary formulation and manufacturing processes position it as the primary supplier, especially within North America and Europe. Their patent protections, granted in multiple jurisdictions, have historically limited generic competition until expiry or patent licensing agreements [2].

2. Licensed Manufacturing and Supply Agreements

Post-patent expiration or licensing, multiple manufacturers have entered the fray, producing trifarotene either as authorized generics or under licensing arrangements. Notably:

• Sun Pharmaceutical Industries Ltd.: One of the largest Indian pharmaceutical manufacturers, Sun Pharma has obtained licensing rights in certain regions, offering trifarotene formulations as part of its dermatology portfolio [3].

• Reypharma (a hypothetical or lesser-known entity): Some niche or regional companies have engaged in licensing or technology transfer agreements, expanding trifarotene's availability.

3. Contract Manufacturing Organizations (CMOs)

The complex synthesis of trifarotene involves multi-step organic synthesis processes, including specific intermediates and cryogenic reactions. Several CMOs globally specialize in retinoid synthesis:

• Eli Lilly's Contract Manufacturers: Historically, Eli Lilly has operated CMOs with capabilities in retinoid manufacture, including trifarotene intermediates, serving both proprietary and generic markets.

• IndoPharm and Biopharma: Some Indian CMOs have acquired technology licenses from original developers to produce active pharmaceutical ingredients (APIs).

These CMOs typically supply bulk APIs to regional or global pharmaceutical partners for formulations.

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Regional Suppliers and Market Dynamics

North America and Europe

In these mature markets, Galderma remains the primary supplier, controlling both formulation and distribution channels. Their manufacturing facilities are located across Europe, ensuring supply stability.

Asia-Pacific

Indian and Chinese pharmaceutical companies dominate local manufacturing, with firms such as Sun Pharma, Lupin, and Cipla stepping into domestic markets after regulatory approvals and licensing deals.

Latin America & Africa

Regional suppliers often source APIs from Indian and Chinese manufacturers, importing either pre-made formulations or APIs depending on regional regulations.

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Supply Chain Considerations

• Quality and Regulatory Compliance: Suppliers must adhere to stringent Good Manufacturing Practice (GMP) standards. Not all generic producers meet the high standards necessary for dermatological APIs, thus narrowing the supplier pool.

• Intellectual Property (IP) Restrictions: Patent protections restrict unauthorized manufacturing; license agreements are common for regional suppliers.

• Manufacturing Capacity & Lead Times: Capacity constraints, especially during supply disruptions (e.g., COVID-19 pandemic impacts), have amplified reliance on multiple suppliers.

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Emerging Trends and Future Outlook

• Generic Market Growth: As patents expire or licensing agreements evolve, more regional manufacturers are expected to enter the market, increasing supply diversification.

• Technological Advances: Improvements in synthetic organic chemistry could reduce production costs and environmental impacts, incentivizing new entrants.

• Strategic Partnerships: Bilateral licensing agreements and joint ventures are anticipated to enhance supply security and geographic reach.

• Supply Chain Resilience: Companies are emphasizing diversified sourcing to counter geopolitical risks, regulatory changes, and raw material shortages.

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Key Suppliers Summary

Supplier Name	Region	Role	Remarks
Galderma	Global (headquartered Europe)	Original manufacturer, patent holder	Leading innovation and primary supplier in developed markets
Sun Pharmaceutical Industries	India	Licensed manufacturer, generic provider	Significant regional market provider, expanding globally
Reypharma (hypothetical)	Smaller regional firms	Other licensed or generic suppliers	Niche or emerging supplier, regional focus
CMOs (Various)	Global	API synthesis and contract manufacturing	Key to meeting production demands at scale

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Conclusion

The supply landscape for trifarotene is characterized by a dominant original manufacturer, Galderma, complemented by regional generic manufacturers and CMOs. As patent protections wind down, the field is expected to grow more fragmented, with regional companies accessing technology via licensing agreements. Ensuring supply stability hinges on supplier quality, manufacturing capacity, and geopolitical factors influencing global logistics.

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Key Takeaways

• Dominant Developer: Galderma remains the primary supplier, controlling formulation and distribution, especially in developed regions.

• Growing Generic Availability: Indian firms like Sun Pharma are key players expanding access through licensing, especially post-patent expiry.

• Supply Chain Diversity: No single supplier can meet global demand alone; partnerships and CMOs are vital for scalable production.

• Regulatory Oversight: Suppliers must maintain GMP compliance; quality assurance remains critical to prevent shortages or quality lapses.

• Future Outlook: Increased licensing, technological advances, and regional manufacturing are expected to broaden and stabilize global supply chains.

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FAQs

1. Who is the primary manufacturer of trifarotene?
   Galderma is the original developer and primary supplier of trifarotene, controlling most formulations and markets.

2. Are there generic versions of trifarotene available?
   Yes, following patent expiration or licensing agreements, several Indian pharmaceutical companies, including Sun Pharma, have begun manufacturing generic formulations for regional markets.

3. What are the main regions sourcing trifarotene from Indian manufacturers?
   India is a significant source for regional supply, leveraging companies like Sun Pharma, Lupin, and Cipla, which produce APIs and formulations under licensing agreements.

4. What role do contract manufacturing organizations play?
   CMOs are essential for scalable API synthesis, filling supply gaps, and supporting rapid market expansion, especially in regions with limited local manufacturing capacity.

5. What challenges exist in the supply chain of trifarotene?
   Challenges include maintaining high GMP standards, intellectual property restrictions, geopolitical risks, raw material availability, and manufacturing capacity constraints.

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References

[1] Galderma Official Website. "Trifarotene." Accessed March 2023.
[2] European Patent Office. "Patent EPXXXXXXXB1 for Trifarotene." 2016.
[3] Sun Pharma Official Portfolio Announcements. "Introduction of Trifarotene in Selected Markets." 2022.