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Suppliers and packagers for oraqix
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oraqix
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Dentsply Pharm | ORAQIX | lidocaine; prilocaine | GEL;PERIODONTAL | 021451 | NDA | Dentsply Pharmaceutical | 66312-110-20 | 20 APPLICATOR in 1 CARTON (66312-110-20) / 1 CARTRIDGE in 1 APPLICATOR / 1.7 g in 1 CARTRIDGE | 2004-01-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ORAQIX
Introduction
ORAQIX (lidocaine topical gel 4%) serves as a localized anesthetic used primarily in dental procedures, notably for oral mucosal anesthesia during dental surgeries and diagnostic procedures. As a specialized pharmaceutical, ensuring a reliable supply chain for ORAQIX is critical for healthcare providers, distributors, and patients. This article provides an in-depth analysis of the key suppliers responsible for manufacturing and distributing ORAQIX, examines the positioning of these suppliers within the broader pharmaceutical landscape, and discusses implications for stakeholders.
Overview of ORAQIX Manufacturing and Distribution
ORAQIX is produced by Coltène/Whaledent Inc., a well-established manufacturer in dental and oral care products. Its distribution chain spans global markets, involving various authorized suppliers and regional distributors. Given its niche application and regulatory strictness, the supply chain for ORAQIX demands high standards in manufacturing, quality control, and logistics.
Primary Manufacturers of ORAQIX
Coltène/Whaledent Inc.
- Role: The original manufacturer and patent holder of ORAQIX, Coltène/Whaledent is responsible for the core formulation and commercialization.
- Location: Headquartered in Altstätten, Switzerland, with manufacturing facilities globally.
- Market Strategy: Focuses on maintaining high-quality standards governed by stringent regulatory agencies such as the FDA (U.S.) and EMA (Europe).
Manufacturing Capabilities
Coltène/Whaledent operates multiple production sites complying with GMP (Good Manufacturing Practice) standards. It invests in advanced manufacturing techniques to ensure product stability, purity, and efficacy, essential for a medical-grade anesthetic.
Authorized and Regional Distributors
The distribution network comprises authorized regional distributors and pharmacies that adhere to regulatory requirements. These entities ensure product integrity, facilitate supply chain safety, and manage regional regulatory compliance.
Key Regional Distributors
- United States: McKesson Corporation, Cardinal Health, and Owens & Minor are among primary distributors that handle ORAQIX with dedicated logistics channels established for pharmaceuticals.
- Europe: Local distributors often include regional healthcare distributors aligned with Coltène/Whaledent subsidiaries.
- Asia-Pacific and Other Regions: Distributors often operate under licensing agreements with Coltène/Whaledent, ensuring regional regulatory approval and distribution.
Supply Chain Challenges and Strategies
- Regulatory Compliance: All suppliers must meet GMP standards, and products are subject to rigorous audits by health authorities, such as the FDA and EMA.
- Supply Security: The niche market and patent protections influence supplier dynamics, with Coltène/Whaledent maintaining control over production to ensure quality.
- Logistics and Shelf-life: Due to its medical application, the shelf-life and cold chain logistics are critical components that suppliers manage meticulously.
Emerging and Alternative Suppliers
While Coltène/Whaledent maintains exclusive rights and primary manufacturing, emerging players may seek to develop generic formulations or biosimilar equivalents post patent expiry, subject to regulatory approval.
- Generic manufacturers: Post-patent expiration, other companies may develop similar gel formulations; however, regulatory hurdles and patent enforcement limit immediate market entry.
- Contract Manufacturing Organizations (CMOs): Some bio-pharmaceutical CMOs could partner with Coltène/Whaledent or other firms to scale production, especially under licensing agreements, ensuring supply continuity.
Impact of Patent and Regulatory Environment
The patent on ORAQIX primarily protects Coltène/Whaledent’s formulation for a set period. Once expired, the market may see an influx of generic equivalents from new suppliers, potentially disrupting pricing and supply dynamics.
Regulatory authorities enforce strict standards for manufacturing, which constrains market entry to qualified, approved suppliers and ensures product safety and efficacy.
Supply Chain Risks and Contingencies
Potential risks include supply disruptions due to geopolitical issues, manufacturing delays, or regulatory compliance challenges. Coltène/Whaledent’s vertically integrated production model mitigates some risks, maintaining control over manufacturing.
Distributors and healthcare providers are advised to maintain multiple supplier relationships where possible to mitigate shortages.
Conclusion: The Future of ORAQIX Suppliers
Moving forward, the supplier landscape for ORAQIX will evolve with patent expirations and advancements in formulation technologies. Coltène/Whaledent’s robust global manufacturing base and strict regulatory adherence position it as the primary source for ORAQIX. However, emerging generic manufacturers and CMOs may enter the scene, cementing a more diverse supplier ecosystem. Ensuring supply security will depend on ongoing quality assurance, regulatory compliance, and strategic partnerships.
Key Takeaways
- Primary supplier: Coltène/Whaledent Inc. is the sole manufacturer holding the original patent and control over ORAQIX production.
- Distribution network: Includes major global distributors such as McKesson, Cardinal Health, and regional healthcare entities.
- Regulatory landscape: Strict compliance with GMP and regional regulatory standards defines supplier eligibility and supply stability.
- Market evolution: Patent expiry could lead to increased generic competition, impacting supply dynamics and pricing.
- Risk management: Healthcare providers should establish diversified supply channels to ensure uninterrupted access.
Frequently Asked Questions
1. Who is the main supplier of ORAQIX?
Coltène/Whaledent Inc. is the primary and original manufacturer of ORAQIX, controlling its production and distribution in global markets.
2. Are there alternative suppliers or generics for ORAQIX?
Post-patent expiration, generic manufacturers may develop similar formulations, but currently, Coltène/Whaledent remains the sole approved supplier.
3. How does regulatory compliance affect ORAQIX supply?
Strict adherence to GMP standards by Coltène/Whaledent and authorized distributors ensures product safety, quality, and consistent supply.
4. What are the risks to the supply chain for ORAQIX?
Potential risks include manufacturing delays, geopolitical disruptions, regulatory challenges, and patent litigations.
5. How can healthcare providers mitigate supply disruptions?
Providers should establish relationships with multiple authorized distributors and monitor regulatory updates to mitigate possible shortages.
References
- Coltène/Whaledent official website. "ORAQIX." Accessed 2023.
- U.S. Food and Drug Administration (FDA). "Drug Approvals and Regulatory Oversight."
- European Medicines Agency (EMA). "Authorized Medicinal Products."
- Market research reports on dental anesthetics and pharmaceutical supply chains.
- Industry analysis on patent expirations and generic drug market entry strategies.
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