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Suppliers and packagers for QUILLIVANT XR
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QUILLIVANT XR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Nextwave | QUILLIVANT XR | methylphenidate hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 202100 | NDA | NextWave Pharmaceuticals, Inc | 24478-321-02 | 1 BOTTLE in 1 CARTON (24478-321-02) / 60 mL in 1 BOTTLE | 2012-10-01 |
| Nextwave | QUILLIVANT XR | methylphenidate hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 202100 | NDA | NextWave Pharmaceuticals, Inc | 24478-322-04 | 1 BOTTLE in 1 CARTON (24478-322-04) / 120 mL in 1 BOTTLE | 2012-10-01 |
| Nextwave | QUILLIVANT XR | methylphenidate hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 202100 | NDA | NextWave Pharmaceuticals, Inc | 24478-323-05 | 1 BOTTLE in 1 CARTON (24478-323-05) / 150 mL in 1 BOTTLE | 2012-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: QUILLIVANT XR
Introduction
The pharmaceutical landscape consistently evolves with the introduction of novel formulations designed to optimize patient outcomes. Quillivant XR, a proprietary extended-release methylphenidate hydrochloride formulation, stands out as a notable intervention for ADHD management. Its unique delivery system necessitates a specialized manufacturing process and a dedicated supply chain. This article explores key suppliers involved in producing Quillivant XR, addressing the components, raw materials, and manufacturing partners integral to its production, alongside market implications and supply chain resilience.
Overview of Quillivant XR
Quillivant XR (methylphenidate hydrochloride extended-release oral suspension) is manufactured by Pfizer Inc., approved by the U.S. Food and Drug Administration (FDA) in 2013. It provides a once-daily, long-acting delivery of methylphenidate, delivering symptomatic relief for attention deficit hyperactivity disorder (ADHD) patients [1].
The drug’s formulation involves complex components, including active pharmaceutical ingredients (API), excipients, and specialized delivery systems such as the extended-release polymer matrix. Understanding the supply chain requires dissecting both the API suppliers and formulation components.
Key Suppliers of the Active Pharmaceutical Ingredient
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Methylphenidate Hydrochloride API Suppliers
As the core component, the methylphenidate hydrochloride API is sourced globally. Leading manufacturers include:
- Cambridge Oxygen and Chemical Ltd. (UK): Supplies methylphenidate compounds, including variants for extended-release formulations.
- Jubilant Pharmova (India): A prominent API manufacturer producing methylphenidate for various formulations, including controlled-release systems.
- Macleods Pharmaceuticals (India): Known for generic APIs, including methylphenidate hydrochloride, supplied to major pharmaceutical companies.
- Siegfried AG (Germany): A contract manufacturer providing methylphenidate API under tightly controlled quality standards.
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Compliance and Quality Standards
Suppliers for API must adhere to Good Manufacturing Practice (GMP) standards, with certifications from authorities such as the FDA, EMA, or WHO prequalifications. Pfizer conducts rigorous audits to ensure raw material traceability and consistency.
Excipients and Delivery System Components
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Extended-Release Polymer Materials
Quillivant XR employs a controlled-release formulation based on polymer matrices. Suppliers include:
- Lubrizol Corporation: Provides sustained-release delivery polymers that regulate API release.
- SNF Floerger: Supplies controlled-release hydrogel polymers used in oral suspension formulations.
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Suspension Excipients
Critical components such as suspending agents, stabilizers, pH adjusters, and flavoring agents are sourced from suppliers like:
- Tocris Bioscience: Provides excipients compatible with oral suspensions.
- Meggle GmbH: Supplies lactose-based excipients for suspension stability.
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Colorants and Flavorings
To improve palatability, Pfizer partners with flavoring companies such as:
- Firmenich or Givaudan for flavoring agents.
- Food-grade colorant suppliers certified for pharmaceutical use.
Manufacturing Partners and Contract Manufacturers
Pfizer employs a multi-tiered manufacturing ecosystem:
- Primary APIManufacturers: Focused on methylphenidate hydrochloride synthesis.
- Formulation and Filling Facilities: Specialized in suspension manufacturing, often located in regions with advanced pharmaceutical infrastructure, such as the United States, Ireland, or India.
- Packaging Partners: Responsible for child-resistant containers and labeling.
Pfizer tracks its supply chain using a Quality Agreement framework with these partners, ensuring consistent product quality and regulatory compliance.
Supply Chain Challenges and Market Dynamics
The complexity of Quillivant XR’s supply chain underscores vulnerabilities to disruptions. The reliance on API suppliers from India and Europe introduces geopolitical and logistical risks, such as trade restrictions or raw material shortages. Moreover, the specialized delivery system components require just-in-time inventory management, demanding accurate forecasting and robust supplier networks.
Pfizer’s strategic partnerships and vertical integration efforts aim to mitigate these risks, though ongoing geopolitical considerations and raw material availability remain critical factors influencing supply stability.
Market and Regulatory Considerations
The broad global market for ADHD medications, valued at approximately $17.9 billion in 2022 and projected to grow, emphasizes the importance of a reliable supply chain for Quillivant XR [2]. Regulatory bodies globally enforce strict standards on manufacturing and distribution, reinforcing the necessity for certifying suppliers' compliance with GMP, ISO standards, and API purity thresholds.
Imp achieving supply continuity necessitates diligent supplier qualification, contingency planning, and ongoing quality audits.
Future Outlook and Innovations
Advancements in biopharmaceutical manufacturing, such as continuous manufacturing processes and novel delivery systems (e.g., implantable or transdermal patches), could impact the supply dynamics of drugs like Quillivant XR. Additionally, biosimilar and generic competition from API producers from emerging economies may influence pricing and supply stability.
Companies are also investing in blockchain technologies to enhance transparency and traceability across the supply chain, potentially mitigating counterfeit or substandard raw materials.
Key Takeaways
- Diverse API Suppliers: Quillivant XR’s API is sourced globally, primarily from India and Europe, necessitating rigorous qualification to ensure consistency.
- Complex Formulation Components: The extended-release system involves specialized polymers and excipients from dedicated suppliers like Lubrizol and SNF Floerger.
- Manufacturing Ecosystem: Pfizer partners with various contract manufacturers across multiple regions, requiring robust quality agreements.
- Supply Chain Resilience: Geopolitical, logistical, and raw material challenges require strategic planning, diversified sourcing, and advanced traceability.
- Market Expansion: Growing demand for ADHD therapies underscores the need for reliable, compliant supply chains to support global distribution.
FAQs
1. Who are the primary suppliers of methylphenidate hydrochloride API for Quillivant XR?
Major global API manufacturers include Jubilant Pharmova, Macleods Pharmaceuticals, Siegfried AG, and Cambridge Oxygen and Chemical Ltd., all complying with GMP standards to ensure pharmaceutical quality.
2. What components are critical for the extended-release formulation of Quillivant XR?
The formulation relies on specialized polymers supplied by companies like Lubrizol and SNF Floerger, which control the drug’s release profile within the suspension.
3. How does Pfizer ensure the quality of its supply chain for Quillivant XR?
Pfizer conducts rigorous audits, enforces strict GMP compliance, and maintains qualified supplier agreements to uphold product consistency and safety.
4. What are potential vulnerabilities in the supply chain of Quillivant XR?
Dependence on API production in emerging economies, geopolitical risks, raw material shortages, and complex formulation components present vulnerabilities that require strategic mitigation.
5. Are there emerging technologies that could impact the supply of drugs like Quillivant XR?
Yes, innovations such as continuous manufacturing, blockchain for traceability, and advanced delivery systems could enhance supply chain resilience and product efficacy.
References
[1] FDA. (2013). FDA Approval for Quillivant XR.
[2] Grand View Research. (2022). ADHD Therapeutics Market Analysis.
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