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Suppliers and packagers for generic pharmaceutical drug: TAPINAROF
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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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Tapinarof
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.
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.
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).
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