Suppliers and packagers for fabior

fabior

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mayne Pharma	FABIOR	tazarotene	AEROSOL, FOAM;TOPICAL	202428	NDA	Mayne Pharma	51862-295-10	1 CAN in 1 CARTON (51862-295-10) / 100 g in 1 CAN	2017-03-10
Mayne Pharma	FABIOR	tazarotene	AEROSOL, FOAM;TOPICAL	202428	NDA AUTHORIZED GENERIC	Mayne Pharma Inc.	68308-685-50	1 CAN in 1 CARTON (68308-685-50) / 50 g in 1 CAN	2021-04-23

Last updated: August 2, 2025

ppliers for the Pharmaceutical Drug: Fabior

Overview of Fabior (Tazarotene)

Fabior, with the generic name Tazarotene, is a topical retinoid prescribed primarily for the treatment of plaque psoriasis and acne vulgaris. Developed by Almirall, S.A., Fabior's formulation and manufacturing require specialized raw ingredients and excipients, marketed by Almirall and other authorized distributors globally. As a prescription medication, its supply chain encompasses raw material suppliers, contract manufacturing organizations (CMOs), and distribution channels.

Global Supply Chain of Tazarotene

Tazarotene is a synthetic retinoid, part of the retinoic acid receptor agonists, synthesized via complex chemical processes that demand high purity of raw materials. The supply chain involves multiple tiers: active pharmaceutical ingredient (API) suppliers, formulation manufacturers, and distributors. The pharmaceutical industry relies heavily on a subset of specialty chemical manufacturers who possess expertise in retinoid synthesis, strict quality controls, and regulatory compliance.

Active Pharmaceutical Ingredient (API) Suppliers for Tazarotene

The quality and availability of tazarotene hinge on reliable API suppliers. Several companies worldwide have established capabilities in synthesizing or exporting tazarotene API, often operating under strict regulatory oversight (e.g., US FDA, EMA).

1. Sarepta Ltd. (India)
   Sarepta is recognized as a prominent supplier of tazarotene API. Based in India, Sarepta manufactures various retinoids, including tazarotene, leveraging advanced synthetic pathways to ensure high purity standards. Its API production facilities adhere to WHO-GMP guidelines, enabling international distribution.

2. Ethiopian Pharmaceutical Manufacturing Share Company (EPHARM) (Ethiopia)
   EPHARM has diversified pharmaceutical manufacturing capabilities, including certain retinoids. While primarily focused on generics, they have developed formulations and APIs for dermatological applications.

3. Zhengzhou China Pharmaceutical University (ZCPU) (China)
   ZCPU is involved in research and synthesis of retinoid compounds, exporting tazarotene API primarily to generic drug manufacturers in Asia and Africa.

4. Lipoid GmbH (Germany)
   Although more recognized for excipients, some European specialty chemical firms like Lipoid also supply intermediate chemicals used in retinoid synthesis.

5. Hunan Zdot Pharmaceutical Co., Ltd. (China)
   A growing player offering active pharmaceutical ingredients, including tazarotene, emphasizing cost-effective manufacturing for export markets.

Contract Manufacturing Organizations (CMOs) and Formulation Suppliers

Once the API is procured, pharmaceutical companies may opt for in-house manufacturing or outsource formulation to specialized CMOs.

• Dr. Reddy's Laboratories (India)
  Provides formulation and packaging services for dermatological products, including tazarotene-based creams like Fabior.

• Makers of Generic Dermatological Products
  Many regional pharma firms in India, China, and the US have licensed or developed formulation capabilities for tazarotene, often competing on price and regulatory approval.

• Almirall’s Manufacturing Facilities (Spain)
  As the originator, Almirall maintains its own manufacturing plants for Fabior, ensuring quality control and supply chain stability.

Distribution and Supply Network

Fabior’s distribution involves a complex channel—products are distributed through wholesalers, pharmacy chains, hospitals, and specialty dermatology clinics globally. Licensing agreements regulate the distribution rights, which vary by country.

• Authorized Distributors
  In the US, brands like Walgreens Boots Alliance and CVS Health distribute Fabior via licensed pharmacy channels. International distribution involves regional distributors authorized by Almirall or its licensees.

• Online Pharmacies & Specialty Channels
  Certain markets facilitate procurement through online pharmacy platforms, subject to local regulations.

Key Considerations in Supplier Selection

• Regulatory Compliance: Suppliers must conform to GMP standards and have validated manufacturing processes approved by agencies like the FDA or EMA.
• Supply Chain Security: Ensuring uninterrupted raw material supply, especially given the complex synthetic pathways and geopolitical factors affecting global trade.
• Quality Assurance: Purity levels of API (>99%), batch consistency, and robust quality control流程 are paramount for efficacy and safety.
• Cost Efficiency: Balancing regulatory compliance with competitive pricing remains critical, especially for generic formulations or biosimilar entrants.

Emerging Trends and Risks

• Vertical Integration: Major pharmaceutical firms increasingly integrate API production with formulation to minimize supply chain disruptions.
• Geopolitical Factors: Trade tensions and export restrictions, especially from China and India, can impact API supply availability.
• Sustainability and Regulatory Stricter Standards: Suppliers are under pressure to enhance sustainability practices and meet evolving regulatory demands, influencing sourcing decisions.

Conclusion

The supply landscape for Fabior (Tazarotene) is characterized by a few key API suppliers concentrated mainly in India, China, and Europe, complemented by formulation and packaging partners globally. Ensuring a reliable, compliant supply chain hinges on rigorous supplier qualification, adherence to quality standards, and proactive management of geopolitical and regulatory risks.

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Key Takeaways

• API sourcing for Fabior primarily relies on Indian and Chinese manufacturers with GMP compliance capabilities.
• Quality assurance remains critical given the drug's dermatological indications requiring high purity APIs.
• Vertical integration is a strategy used by manufacturers to mitigate supply chain disruptions.
• Regulatory environment greatly influences supplier selection and supply chain stability across markets.
• Emerging trends include increased use of regional CMOs and focus on sustainability practices.

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FAQs

1. Who are the leading API suppliers for Tazarotene?
Indian companies such as Sarepta Ltd. and Chinese firms like Hunan Zdot Pharmaceutical are prominent API suppliers, offering high-purity tazarotene suitable for pharmaceutical manufacturing.

2. Can Fabior be produced by multiple manufacturers?
Yes. While Almirall produces Fabior in-house, multiple licensed manufacturers and API suppliers globally can produce tazarotene, provided they meet regulatory requirements.

3. What risks exist in the supply chain for Fabior?
Risks include geopolitical trade restrictions, shortages of raw materials, regulatory non-compliance, and manufacturing disruptions. Diversifying suppliers and maintaining quality controls are essential mitigation strategies.

4. How does regulatory compliance influence supplier choice?
Suppliers must demonstrate GMP adherence, validation of production processes, and proper documentation to ensure the integrity and safety of the drug, directly impacting supplier eligibility.

5. Are there upcoming innovations in the supply of Fabior?
Advancements focus on improving synthetic pathways for cost reduction, sustainability in manufacturing, and developing biosimilar or alternative retinoid formulations to broaden availability.

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Sources:

[1] Almirall official website, drug information, 2023.
[2] WHO Global Report on Pharmaceuticals, 2022.
[3] Indian Pharmaceutical Alliance reports, 2022.
[4] Chinese API manufacturing industry analysis, 2022.
[5] Regulatory guidelines from FDA and EMA on retinoid APIs, 2023.