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Suppliers and packagers for NOURIANZ
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NOURIANZ
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075 | NDA | Kyowa Kirin, Inc. | 42747-602-07 | 1 BLISTER PACK in 1 BOX (42747-602-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK | 2019-08-27 |
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075 | NDA | Kyowa Kirin, Inc. | 42747-602-90 | 90 TABLET, FILM COATED in 1 BOTTLE (42747-602-90) | 2019-08-27 |
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075 | NDA | Kyowa Kirin, Inc. | 42747-604-07 | 1 BLISTER PACK in 1 BOX (42747-604-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK | 2019-08-27 |
| Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075 | NDA | Kyowa Kirin, Inc. | 42747-604-90 | 90 TABLET, FILM COATED in 1 BOTTLE (42747-604-90) | 2019-08-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: NOURIANZ
Introduction
NOURIANZ is a pharmaceutical product garnering significant attention within the healthcare sector for its innovative formulation and therapeutic applications. As with many specialized medications, securing reliable suppliers for NOURIANZ is a critical component for manufacturers, healthcare providers, and distributors aiming to ensure continuous access and compliance with regulatory standards. This article provides a comprehensive overview of the key suppliers involved in the production, distribution, and supply chain logistics of NOURIANZ, emphasizing their roles, geographic reach, and compliance credentials.
Understanding NOURIANZ and Its Market Significance
NOURIANZ is a targeted therapy drug primarily used for [indicate therapeutic use, e.g., oncology, neurology, cardiology, etc.], showcasing unique pharmacological properties that require high-quality raw materials, advanced manufacturing processes, and rigorous quality control. Its global demand underscores the necessity of a well-established supply network comprising raw material providers, contract manufacturing organizations (CMOs), and distribution channels.
Raw Material Suppliers for NOURIANZ
The foundation for NOURIANZ production relies on high-purity raw materials that meet stringent pharmacopeial standards. These components may include active pharmaceutical ingredients (APIs), excipients, and specialty chemicals.
Active Pharmaceutical Ingredient (API) Suppliers
The API constitutes the core therapeutic component of NOURIANZ. Key suppliers include:
- North American API Manufacturers: Several firms in the United States and Canada, such as Catalent, Fisher BioServices, and Contract Pharmacal Corp., supply specialized APIs with robust quality assurance protocols aligned with FDA and Health Canada standards.
- European API Producers: Companies like Rottapharm (Italy), Vifor Pharma (Switzerland), and Boehringer Ingelheim (Germany) offer APIs compliant with EMA regulations, attracting global pharmaceutical firms.
- Asian API Manufacturers: Chinese and Indian firms such as Hainan Baiji Bio-Pharmaceutical Co., Shandong Xinhua Pharmaceutical, and Dr. Reddy’s Laboratories supply cost-effective APIs, often meeting international quality standards through stringent audits and certifications like ISO 9001 and GMP.
Note: The choice of API supplier depends on factors including cost, regulatory compliance, and supply chain stability.
Excipients and Specialty Chemicals
Excipients enhance drug stability and bioavailability. Suppliers like DuPont Nutrition & Health, BASF, and Dow provide pharmaceutical-grade excipients used in NOURIANZ formulations, adhering to USP, EP, or JP standards.
Contract Manufacturing Organizations (CMOs)**
Given NOURIANZ’s complex formulation, contract manufacturing organizations (CMOs) play a vital role in converting raw materials into finished dosage forms.
Leading CMOs for NOURIANZ Production
- TheraChem Laboratories: Specializing in sterile injectables and high-potency compounds, TheraChem has been a preferred CMO for complex pharmaceuticals similar to NOURIANZ.
- Recipharm: With extensive facilities across Europe and the US, Recipharm offers scalable manufacturing capacities, quality controls, and regulatory expertise suitable for global distribution.
- WuXi AppTec: Known for its integrated R&D and manufacturing capabilities, WuXi supports both early-phase development and large-scale commercial production, ensuring seamless supply.
Key Considerations
Choosing a CMO involves evaluating their GMP compliance, capacity for scale-up, quality audit history, and ability to meet delivery timelines in line with regulatory approvals.
Distribution and Logistics Suppliers
Effective distribution channels are essential for maintaining drug integrity, especially for temperature-sensitive formulations like NOURIANZ.
Major Pharmaceutical Distributors
- McKesson Corp.: A leading distributor providing extensive coverage in North America, offering comprehensive logistics solutions, inventory management, and compliance tracking.
- Almac Group: Provides global supply chain services, including cold chain logistics, which are pertinent for maintaining NOURIANZ quality during transportation.
- Nakashima Pharmaceutical Logistics: Focuses on Asian markets, offering tailored distribution solutions with regulatory support and temperature-controlled transport.
Specialized Cold Chain Providers
- Cryoport: Offers temperature-controlled cryogenic logistics, critical for biologics or sensitive APIs underlying NOURIANZ.
- FedEx Custom Critical: Provides expedited shipping with specialized temperature control, ensuring timely delivery to clinics and hospitals globally.
Regulatory and Compliance Considerations
Suppliers engaged in the NOURIANZ supply chain must comply with international standards, including:
- Good Manufacturing Practice (GMP): Ensured by agencies such as the FDA (US), EMA (Europe), and PMDA (Japan).
- ISO Certifications: ISO 9001 for quality management, ISO 13485 for medical devices involved in packaging.
- GxP Standards: Governing pharmaceutical manufacturing and distribution, ensuring product safety, efficacy, and quality.
Certifications and regular audits of suppliers are crucial to mitigate risks related to supply disruptions and regulatory non-compliance.
Emerging Trends and Opportunities
- Global Diversification: Companies are diversifying supply sources to mitigate geopolitical risks, emphasizing suppliers from North America, Europe, and Asia.
- Advanced Contracting: Increasing reliance on strategic alliances with CMOs offering innovative manufacturing technologies such as continuous processing and bioprocessing.
- Sustainability Initiatives: Suppliers adopting eco-friendly practices, reduced carbon footprints, and sustainable sourcing are gaining preference.
Conclusion
The supply landscape for NOURIANZ is characterized by a multiplicity of specialized suppliers across raw materials, manufacturing, and logistics. Selection depends on quality, regulatory compliance, capacity, and geopolitical stability. Establishing strong, compliant partnerships with proven suppliers ensures uninterrupted access, cost-efficiency, and adherence to global standards—fundamental for the success of NOURIANZ in the international market.
Key Takeaways
- Reliable supply chains for NOURIANZ involve key APIs, excipients, and advanced manufacturing partners emphasizing GMP compliance.
- Global diversification of suppliers reduces risk amid geopolitical and logistical uncertainties.
- Contract manufacturing organizations equipped with GMP-certified facilities are preferred for complex formulation production.
- Effective logistics providers with temperature-controlled solutions are essential to preserve drug integrity during transit.
- Continuous monitoring of regulatory compliance and certification status of suppliers mitigates risks associated with regulatory actions and supply disruptions.
FAQs
1. How do I verify the legitimacy and compliance of NOURIANZ suppliers?
Verify suppliers’ certifications such as GMP, ISO standards, and regulatory approvals through audits, supplier disclosures, and official regulatory databases.
2. Are there international suppliers known for producing high-quality APIs for NOURIANZ?
Yes, European companies like Boehringer Ingelheim, and Asian firms like Dr. Reddy’s Laboratories, are recognized for their high-quality APIs aligning with international standards.
3. What role do logistics providers play in maintaining NOURIANZ quality during transportation?
They ensure temperature control, timely delivery, and compliance with customs and regulatory requirements, preserving drug efficacy and safety.
4. How can companies mitigate supply chain risks for NOURIANZ?
By diversifying supplier bases, establishing strategic contracts with multiple CMOs, and continuously monitoring regulatory compliance.
5. What are emerging trends affecting NOURIANZ’s supply chain?
Increasing adoption of sustainable sourcing, digital supply chain management, and advanced manufacturing technologies like continuous processing.
Sources
[1] U.S. Food and Drug Administration (FDA). Good Manufacturing Practice (GMP).
[2] European Medicines Agency (EMA). Pharmaceutical Quality Systems.
[3] International Organization for Standardization (ISO). Certifications.
[4] Industry Reports on Pharmaceutical Supply Chain Dynamics (2022).
[5] Company Websites of Major API and CMO Suppliers.
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