Suppliers and packagers for TAZORAC
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TAZORAC
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Almirall | TAZORAC | tazarotene | CREAM;TOPICAL | 021184 | NDA | Almirall, LLC | 16110-915-30 | 1 TUBE in 1 CARTON (16110-915-30) / 30 g in 1 TUBE | 2020-02-03 |
| Almirall | TAZORAC | tazarotene | CREAM;TOPICAL | 021184 | NDA | Almirall, LLC | 16110-915-60 | 1 TUBE in 1 CARTON (16110-915-60) / 60 g in 1 TUBE | 2020-02-03 |
| Almirall | TAZORAC | tazarotene | CREAM;TOPICAL | 021184 | NDA | Almirall, LLC | 16110-916-30 | 1 TUBE in 1 CARTON (16110-916-30) / 30 g in 1 TUBE | 2020-02-03 |
| Almirall | TAZORAC | tazarotene | CREAM;TOPICAL | 021184 | NDA | Almirall, LLC | 16110-916-60 | 1 TUBE in 1 CARTON (16110-916-60) / 60 g in 1 TUBE | 2020-02-03 |
| Almirall | TAZORAC | tazarotene | CREAM;TOPICAL | 021184 | NDA AUTHORIZED GENERIC | Pacific Pharma, Inc. | 60758-561-30 | 1 TUBE in 1 CARTON (60758-561-30) / 30 g in 1 TUBE | 2017-04-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Tazorac
Introduction
Tazorac, the brand name for tazarotene, is a topical retinoid primarily prescribed for the treatment of psoriasis, acne, and other dermatological conditions. Since its introduction, Tazorac has experienced significant market penetration, driven by its efficacy and unique mechanism of action. Understanding its supply chain, including major suppliers and manufacturing stakeholders, is critical for healthcare providers, distributors, and industry analysts seeking insights into market stability, sourcing reliability, and potential growth opportunities.
Manufacturers of Tazorac
The primary manufacturer of Tazorac is Eli Lilly and Company, a global pharmaceutical giant with extensive experience in dermatology. Eli Lilly owns the rights to Tazorac, overseeing its formulation, manufacturing, and distribution. The company's robust research and development infrastructure ensures a consistent supply chain backed by quality control protocols aligned with regulatory standards (FDA, EMA).
Eli Lilly's manufacturing facilities are strategically located in the United States, with additional distribution centers worldwide, enabling broad global availability. The company's vertically integrated supply chain covers raw material sourcing, formulation, packaging, and distribution, ensuring product integrity and adherence to regulatory compliance.
Key Raw Material Suppliers
The core ingredient in Tazorac, tazarotene, is a synthetic retinoid derivative. The production of tazarotene involves complex organic synthesis processes requiring high-purity starting materials, including specific aromatic and heterocyclic compounds. Suppliers of these raw materials are often specialized chemical manufacturers with globally dispersed facilities.
Major suppliers for the key chemicals involved in tazarotene synthesis include Sigma-Aldrich (Merck KGaA), Thermo Fisher Scientific, and Alfa Aesar. These companies provide pharmaceutical-grade reagents with strict quality certifications necessary for controlled drug synthesis. The supply of raw materials is subject to global chemical market conditions, raw material availability, and adherence to Good Manufacturing Practices (GMP).
Contract Manufacturing Organizations (CMOs)
While Eli Lilly maintains direct control over primary manufacturing, it also collaborates with Contract Manufacturing Organizations (CMOs) for capacity expansion and regional distribution. Notable CMOs involved historically in dermatological drug product manufacturing include Lonza and Catalent. These organizations provide cGMP-compliant facilities capable of handling complex formulations, ensuring product consistency, and scaling production as market demand warrants.
Distribution Channels and Global Suppliers
Once manufactured, Tazorac is distributed through a complex network spanning wholesalers, pharmacies, hospitals, and specialty clinics. Key pharmaceutical distributors such as McKesson, AmerisourceBergen, and Cardinal Health serve as critical nodes in ensuring the drug’s availability across the U.S. and international markets. These distributors source Tazorac directly from Eli Lilly or regional warehouses affiliated with the manufacturer.
In international markets, local subsidiaries, regional distributors, and pharmaceutical importers play vital roles in navigating regulatory approvals and market-specific supply chain nuances. Eli Lilly ensures compliance with these regional regulations through licensing partnerships and local manufacturing agreements where necessary.
Regulatory and Supply Chain Stability
Supply stability for Tazorac hinges on raw material procurement, manufacturing capacity, regulatory approval timelines, and geopolitical factors influencing chemical imports. Eli Lilly’s proactive approach involves maintaining strategic stockpiles, diversified sourcing for raw materials, and rigorous quality assurance practices. Any disruption, such as fluctuations in raw material availability or regulation changes, could impact supply consistency.
Additionally, recent shortages in high-purity chemicals worldwide have prompted Eli Lilly to diversify its supplier base and increase inventory buffers. The company’s engagement with multiple suppliers and inclusion of supplier audits improve resilience against commercial and geopolitical risks.
Market Dynamics and Future Supply Considerations
While Eli Lilly currently dominates Tazorac supply, evolving patent landscapes and potential biosimilar entries could influence the supply chain in the future. Although Tazorac’s patent expired in significant markets, its active ingredient’s synthesis complexity provides a degree of market exclusivity. The emergence of generic tazarotene formulations—produced by smaller regional or international pharmaceutical firms—may introduce alternative sources for the drug.
For stakeholders, monitoring regulatory approvals, patent statuses, and supplier innovations remains essential for assessing future supply stability and sourcing opportunities.
Conclusion
The supply of Tazorac is predominantly managed by Eli Lilly, supported by a global network of chemical suppliers, contract manufacturers, and distribution partners. Ensuring product quality and supply chain resilience relies on diversified sourcing, compliance with quality standards, and regional distribution strategies. As the dermatological market evolves, suppliers’ adaptability and strategic partnerships will be vital in maintaining an uninterrupted supply of Tazorac globally.
Key Takeaways
- Eli Lilly is the primary manufacturer and distributor of Tazorac, leveraging global facilities for supply stability.
- Raw materials for tazarotene synthesis are supplied by specialized chemical companies, with diversified sourcing to mitigate supply risks.
- Contract manufacturing organizations (CMOs) such as Lonza and Catalent facilitate large-scale production and regional distribution.
- Major pharmaceutical distributors ensure broad access to Tazorac in the U.S. and internationally, with logistics sensitive to raw material and geopolitical fluctuations.
- Future supply considerations include patent status, emerging generics, and geopolitical factors influencing raw material sourcing.
FAQs
1. Who are the main manufacturers of Tazorac?
Eli Lilly and Company is the exclusive patent holder and primary manufacturer of Tazorac, overseeing its production and distribution globally.
2. What raw materials are involved in Tazorac production?
Tazarotene, the active compound, is synthesized from high-purity chemical intermediates sourced from specialized chemical suppliers, including companies such as Sigma-Aldrich and Thermo Fisher Scientific.
3. Are there alternative suppliers for Tazorac?
Currently, Eli Lilly holds exclusive rights, but generic formulations of tazarotene may originate from regional pharmaceutical manufacturers, especially following patent expirations in certain jurisdictions.
4. How is the supply chain of Tazorac maintained during disruptions?
Eli Lilly mitigates supply risks through diversified supplier relationships, strategic inventory buffers, and regional manufacturing partnerships, ensuring continuous product availability.
5. What is the outlook for Tazorac supply in the future?
The future of Tazorac supply depends on patent status, regulatory pathways for generics, and the stability of chemical supply markets. Ongoing industry shifts could introduce new suppliers and manufacturing options.
References
[1] Eli Lilly and Company. Tazorac (tazarotene) prescribing information.
[2] Sigma-Aldrich. Chemical reagents for pharmaceutical synthesis.
[3] FDA. Drug Approval and Patent Lifecycle for Dermatological Agents.
[4] MarketSelect. Global dermatology drug market analysis 2022.
[5] Pharmaceutical Technology. Contract manufacturing trends in dermatology.
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