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Suppliers and packagers for OXYTROL
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OXYTROL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Allergan | OXYTROL | oxybutynin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021351 | NDA | Allergan, Inc. | 0023-6153-08 | 8 POUCH in 1 BOX (0023-6153-08) / 1 PATCH in 1 POUCH / 4 d in 1 PATCH | 2003-02-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Oxytrol
Introduction
Oxytrol is a transdermal patch primarily prescribed for overactive bladder (OAB) management. It delivers oxybutynin, an anticholinergic agent that reduces urinary urgency, frequency, and incontinence. As a distinctive topical formulation, Oxytrol’s supply chain involves multiple stakeholders, including active pharmaceutical ingredient (API) producers, contract manufacturing organizations (CMOs), and distribution partners. This analysis examines the key suppliers involved in the production and distribution of Oxytrol, providing insights into the global supply landscape, regulatory considerations, and strategic sourcing imperatives.
Manufacturers of Oxytrol
The original product Oxytrol was developed by BioDelivery Sciences International in collaboration with Glenmark Pharmaceuticals, which holds a significant role in its manufacturing and distribution. Currently, UCB Pharma and Glenmark are among the primary pharmaceutical companies involved in manufacturing and marketing Oxytrol.
Glenmark Pharmaceuticals
Glenmark Pharmaceuticals, headquartered in India, is a significant OEM (original equipment manufacturer) for Oxytrol. The company's vertically integrated supply chain spans from API synthesis to finished dosage form (FDF) manufacturing. Glenmark’s facilities, located in India and other countries, are registered with regulatory authorities such as the FDA and EMA, ensuring compliance with quality standards required for transdermal patches.
UCB Pharma
UCB Pharma, a Belgium-based biopharmaceutical firm, markets Oxytrol in some territories, especially in Europe. UCB's supply chain for Oxytrol involves sourcing from Glenmark's manufacturing facilities or other contract manufacturers. UCB's global footprint enhances distribution channels but relies heavily on the same underlying manufacturing infrastructure.
API Suppliers for Oxybutynin (Active Ingredient)
The active ingredient in Oxytrol, oxybutynin, can be sourced from multiple suppliers worldwide. While proprietary formulations may restrict direct access to APIs, the global API market comprises numerous manufacturers, particularly in India, China, and Europe.
Key API Producers:
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HUBEI WUJIN PHARMACEUTICAL CO., LTD. (China) – a significant producer of generic oxybutynin API, with a focus on high-volume exports to India and Europe.
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Fresenius Kabi (Germany) – provides oxybutynin APIs for various formulations, adhering to stringent European quality standards.
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Mikart (India) – one of the leading API manufacturers with a broad portfolio, including oxybutynin, serving global markets.
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Hunan Huisheng Pharmaceutical Co., Ltd. (China) – an API manufacturer supplying oxybutynin to several generic producers.
Contract Manufacturing Organizations (CMOs)
The production of transdermal patches like Oxytrol involves specialized manufacturing processes, including coating, drug loading, and patch assembly. Many pharmaceutical companies outsource these complex manufacturing steps to CMOs.
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Lonza Group – a leading CMO providing specialized skin patch manufacturing services, including transdermal drug delivery systems.
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Ypsomed – offers manufacturing services for transdermal patches, including design, assembly, and packaging.
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Catalent, Inc. – provides comprehensive CMO services covering formulation development, manufacturing, and packaging.
Distribution and Supply Chain Considerations
Oxytrol’s global distribution relies on a network of licensed distributors, wholesalers, and specialty pharmacies. Manufacturers like Glenmark and UCB typically partner with regional distributors to meet local regulatory standards and ensure a steady supply chain. The logistics involve cold chain management, inventory tracking, and adherence to regulatory requirements for pharmaceuticals.
Regulatory and Quality Compliance
Suppliers across the supply chain must meet stringent regulatory standards, including FDA approvals for manufacturing facilities, ISO certifications, and compliance with WHO guidelines. For API suppliers, Good Manufacturing Practices (GMP) are mandatory for continued supply authorization.
Emerging Trends and Strategic Sourcing
The increasing demand for generic and biosimilar transdermal products intensifies competition among suppliers. Companies are adopting strategic sourcing to mitigate risks associated with supply disruptions, raw material shortages, or regulatory audits.
Diversification of API sourcing and forging robust partnerships with multiple CMOs enhances resilience. Additionally, geographic diversification—particularly sourcing from India and China—reduces costs but requires rigorous quality oversight.
Conclusion
The supply ecosystem for Oxytrol involves a multi-layered network of key suppliers: API producers (notably in India, China, and Europe), contract manufacturers specializing in transdermal patches, and regional distributors. Major pharmaceutical companies like Glenmark and UCB are central to the manufacturing and distribution pipeline, leveraging a combination of internal facilities and outsourcing to CMOs. Ensuring regulatory compliance and supply chain resilience remains paramount for sustained access to Oxytrol across global markets.
Key Takeaways
- Global API sourcing is critical for cost efficiency and supply stability; India and China are dominant players.
- Strategic partnerships with CMOs specializing in transdermal manufacturing mitigate operational risks and improve product quality.
- Regulatory compliance remains a key determinant for suppliers, requiring GMP certification and strict quality controls.
- Diversification of supply sources reduces dependence on single suppliers, enhancing resilience against geopolitical or market disruptions.
- Distribution networks are managed through regional partnerships, ensuring compliance with local regulations and effective logistics.
FAQs
Q1: Who are the primary API suppliers for oxybutynin used in Oxytrol?
A1: Major API suppliers include Mikart (India), Hubei Wujin Pharmaceutical (China), Fresenius Kabi (Germany), and Hunan Huisheng Pharmaceutical (China), all adhering to GMP standards for safety and quality.
Q2: Which contract manufacturers produce the transdermal patches for Oxytrol?
A2: Leading CMOs such as Lonza, Ypsomed, and Catalent provide specialized manufacturing services for skin patches, including coating, drug loading, and packaging.
Q3: What are the key regulatory considerations for suppliers involved in Oxytrol?
A3: Suppliers must comply with GMP standards, hold FDA or EMA approvals, and ensure consistent quality and traceability in raw materials and manufacturing processes.
Q4: How does supply chain diversification impact Oxytrol availability?
A4: Diversification reduces reliance on single suppliers or regions, mitigating risks associated with political instability, supply disruptions, and regulatory changes.
Q5: How are distribution channels managed for Oxytrol across different markets?
A5: Distribution involves regional partners, wholesalers, and specialty pharmacies, with careful logistics planning to ensure product integrity and regulatory compliance.
References
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