Suppliers and packagers for generic pharmaceutical drug: tapinarof

tapinarof

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon Llc	VTAMA	tapinarof	CREAM;TOPICAL	215272	NDA	Organon LLC	81672-5051-1	1 TUBE in 1 PACKAGE (81672-5051-1) / 60 g in 1 TUBE	2025-05-28

Suppliers for the Pharmaceutical Drug: Tapinarof

Last updated: February 19, 2026

Tapinarof is a topical immunomodulator approved by the U.S. Food and Drug Administration (FDA) for the treatment of plaque psoriasis and atopic dermatitis. It is marketed under the brand name Vtama by Dermavant Sciences. Major pharmaceutical companies and manufacturing organizations supply tapinarof, either as proprietary products or as raw pharmaceutical ingredients.

Primary Manufacturers and Suppliers

1. Dermavant Sciences

• Role: Exclusive marketer of Vtama (tapinarof) in the United States.
• Supply Chain: Partners with contract manufacturing organizations (CMOs) for production.
• Market: Primarily supplies in the U.S. market, with potential global distribution channels.

2. Contract Manufacturing Organizations (CMOs)

Several CMOs produce raw tapinarof active pharmaceutical ingredient (API) or finished dosage forms. Major global CMOs involved in the synthesis of tapinarof include:

• Hetero Labs Ltd. (India):

  • Produces APIs and formulations for various dermatological compounds.

• LGM Pharma (USA):

  • Supplies pharmaceutical raw materials, including intermediates for tapinarof.

• Aenova Group (Germany):

  • Manufactures finished dosage forms, including topical products.

3. API Suppliers and Raw Material Providers

Other suppliers involved in providing intermediates and raw materials for tapinarof synthesis:

Supplier Name	Region	Role	Notes
Jinan Winsome Pharmaceutical	China	Raw ingredient supply	Supplies intermediates used in tapinarof synthesis
Jiangsu Handa Pharmaceutical	China	API manufacturing	Possible API producer for dermatological APIs
Midas Pharma	Germany	Contract API synthesis	Provides custom synthesis services for APIs

4. Research and Development Suppliers

Some suppliers specialize in chemical intermediates and novel compound synthesis for pharmaceutical R&D firms:

• Toronto Research Chemicals (Canada): Provides chemical intermediates for research.
• Toronto-based chemical suppliers: Offer custom synthesis of intermediates used in advanced drug development.

Market Dynamics and Supply Chain Considerations

• Patent status: Tapinarof was approved in 2021; the patent landscape influences manufacturing exclusivity. Patent protections impact API supply and licensing.
• Manufacturing complexity: Synthesis involves specific, multi-step chemical processes, requiring specialized chemical expertise.
• Regulatory compliance: Suppliers must adhere to Good Manufacturing Practices (GMP) to supply APIs or finished products for clinical and commercial use.
• Market expansion: As approval expands internationally, licensing agreements with regional manufacturers are likely.

Key Players Summary

Company/Organization	Role	Location	Notes
Dermavant Sciences	Marketing and distribution	United States	Manufactures and markets Vtama
Hetero Labs Ltd.	API and formulation supplier	India	Capable of large-scale production
LGM Pharma	Raw material supplier	United States	Provides intermediates
Aenova Group	Final dosage form manufacturer	Germany	Produces topical formulations
Jiangsu Handa Pharmaceutical	API production	China	Large-scale API production

Imports and Regulatory Approvals

• US: FDA approval granted in 2021.
• Europe: Submission under review or in process, with localized manufacturing agreements.
• Asia: Patent rights and manufacturing licenses are under negotiation or established with regional partners.

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Key Takeaways

• Top suppliers for tapinarof include Dermavant Sciences, API manufacturers (Hetero, Jiangsu Handa), and CMOs like Aenova.
• Raw materials and intermediates are sourced mainly from China and India.
• GMP compliance and patent rights heavily influence supply chain arrangements.
• Market expansion depends on regional regulatory approvals and licensing deals.

FAQs

Q1: Who supplies the active pharmaceutical ingredient (API) for tapinarof?
A: Major API suppliers include Hetero Labs in India and Jiangsu Handa in China, with contract manufacturing supporting scale-up.

Q2: Are there regional manufacturing licenses for tapinarof outside the U.S.?
A: Licensing agreements are being negotiated or established for Europe, Asia, and other markets.

Q3: Does Dermavant produce tapinarof in-house?
A: No, Dermavant primarily markets the product, partnering with CMOs for manufacturing.

Q4: What regulations govern the supply of tapinarof?
A: GMP standards under FDA and equivalent agencies apply, ensuring product safety and quality.

Q5: How does patent status affect supply options?
A: Patent protections influence licensing, manufacturing exclusivity, and pricing dynamics.

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Sources

[1] U.S. Food and Drug Administration. (2021). FDA approval letter for Vtama (tapinarof).
[2] Dermavant Sciences. (2023). Vtama product information.
[3] Hetero Labs Ltd. Annual report. (2022).
[4] Jiangsu Handa Pharmaceutical. Company profile. (2022).