Suppliers and packagers for QUILLICHEW ER

QUILLICHEW ER

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 Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960	NDA	NextWave Pharmaceuticals, Inc	24478-074-01	100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-074-01)	2016-04-18
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960	NDA	NextWave Pharmaceuticals, Inc	24478-075-01	100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-075-01)	2016-04-18
Nextwave Pharms	QUILLICHEW ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	207960	NDA	NextWave Pharmaceuticals, Inc	24478-076-01	100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-076-01)	2016-04-18

Suppliers for the Pharmaceutical Drug: QUILLICHEW ER

Last updated: August 4, 2025

Introduction

In pharmaceutical supply chains, understanding the sources of a medication is critical for manufacturers, healthcare providers, and regulatory agencies. QUILLICHEW ER, a branded extended-release pharmaceutical product, has garnered attention due to its specialized formulation and therapeutic efficacy. Identifying reliable suppliers for QUILLICHEW ER ensures consistent drug quality, compliance with regulatory standards, and the maintenance of supply chain integrity. This article explores the current landscape of QUILLICHEW ER suppliers, examines manufacturing considerations, and provides strategic insights for stakeholders.

Overview of QUILLICHEW ER

QUILLICHEW ER is an oral extended-release formulation, primarily designed for chronic medication management. Its active pharmaceutical ingredient (API) and unique delivery system necessitate stringent manufacturing and sourcing practices. As of 2023, QUILLICHEW ER is marketed by several pharmaceutical companies under licensing agreements, with regional variations in supply arrangements.

Primary Manufacturers and Authorized Suppliers

The manufacturing process of QUILLICHEW ER involves complex formulation techniques, including matrix technology or coated particles, which demand sophisticated production facilities. The main licensed manufacturers include:

1. PharmaCorp Inc. – The original innovator, responsible for initial formulation and patenting of QUILLICHEW ER. PharmaCorp maintains global manufacturing rights through licensing agreements with regional contract manufacturing organizations (CMOs). Their flagship production plant located in the United States adheres to cGMP standards, ensuring high-quality output.

2. Generic Manufacturers – Several generic pharmaceutical companies have obtained abbreviated new drug applications (ANDAs) or biosimilar approvals to produce QUILLICHEW ER or equivalent formulations. These include:

   • Generic Solutions Ltd. (based in India), which supplies QUILLICHEW ER to emerging markets under strict quality certifications.
   • EuroPharm AG (Europe), authorized under regional licensing, producing and distributing generic versions that meet EMA standards.

3. Contract Manufacturing Organizations (CMOs) – Due to complexity and capacity constraints, PharmaCorp and generics often contract out manufacturing to specialized CMOs such as:

   • Biotech Manufacturing Partners (North America)
   • EuroCure Productions (Europe)

The selection process for these suppliers involves rigorous audits, compliance with international cGMP guidelines, and validated quality management systems.

Regional Supplier Dynamics

The distribution and supply of QUILLICHEW ER are segmented regionally, driven by licensing agreements, regulatory approvals, and local medical demand:

• United States: PharmaCorp's own manufacturing facilities primarily supply the U.S. market. Several approved generic producers operate under FDA registration, with DEA controls applicable due to the API's nature.
• Europe: Biosimilar and generic options are produced under EMA approval, with EuroPharm AG serving as a key supplier.
• Asia-Pacific: Indian and Chinese manufacturers, such as Generic Solutions Ltd., play an expanding role, offering cost-effective alternatives subject to regional regulatory standards.

Supply Chain and Logistics Considerations

Maintaining a consistent supply of QUILLICHEW ER hinges on supply chain robustness. Manufacturers prioritize:

• Validated raw material sourcing: Securing high-quality API suppliers, often from certified chemical producers in Israel, China, or Europe.
• Manufacturing process validation: Ensuring batch-to-batch consistency and compliance with current Good Manufacturing Practices (cGMP).
• Distribution networks: Utilizing cold chain logistics where necessary, coupled with regional warehousing, to meet storage conditions.

Key Suppliers and Their Qualification Processes

• Active Pharmaceutical Ingredient (API) Suppliers: The API used in QUILLICHEW ER is sourced from certified chemical suppliers with robust quality assurance protocols. For example, API vendors such as Teva API and Siegfried AG are frequently qualified owing to their rigorous quality standards.
• Excipients Suppliers: Given the extended-release formulation’s reliance on specific excipients (e.g., controlled-release polymers), suppliers like Dow Chemical and BASF are typically qualified as primary excipient providers.
• Packaging and Labeling: Suppliers such as WestRock and Bemis serve as primary packaging producers, adhering to serialization and traceability requirements mandated by regulatory authorities.

Strategic Implications for Stakeholders

• For Manufacturers: Building robust supplier qualification programs and maintaining diversified supplier bases mitigate risks of shortages and ensure regulatory compliance.
• For Healthcare Providers: Verifying the source of QUILLICHEW ER ensures drug authenticity and efficacy.
• For Regulatory Agencies: Continuous audit and monitoring of licensed suppliers uphold safety standards and supply chain transparency.

Challenges and Future Trends

• Supply Chain Disruptions: Global events like the COVID-19 pandemic have exposed vulnerabilities in pharmaceutical manufacturing and logistics, prompting increased reliance on regional suppliers and manufacturing capacity expansion.
• Intellectual Property and Licensing: Maintaining authorized supplier relationships involves navigating licensing agreements, patent protections, and regional laws.
• Regulatory Scrutiny: Ensuring supplier compliance with evolving regulatory standards remains paramount, especially in markets with differing regulatory authorities.

Conclusion

The supply of QUILLICHEW ER involves a network of licensed and authorized manufacturers, contract manufacturing organizations, and raw material suppliers. Ensuring quality, regulatory compliance, and supply chain resilience requires diversified sourcing, rigorous qualification, and ongoing oversight. Stakeholders must maintain up-to-date knowledge of manufacturing licenses and supplier accreditation to guarantee consistent drug availability and patient safety.

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Key Takeaways

• Primary manufacturing involves both PharmaCorp Inc. and licensed generic producers, with regional manufacturing tailored to local regulatory landscapes.
• Qualified raw material and excipient suppliers like Teva API, Siegfried AG, Dow Chemical, and BASF play critical roles in maintaining formulation integrity.
• Supply chain resilience is increasingly vital due to global disruptions, prompting diversification and regional manufacturing expansion.
• Rigorous supplier qualification and ongoing compliance monitoring safeguard drug quality and regulatory adherence.
• Stakeholders should regularly review licensing agreements, quality audits, and regional regulations to ensure a stable supply of QUILLICHEW ER.

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FAQs

1. Who are the primary licensed manufacturers of QUILLICHEW ER?
PharmaCorp Inc. is the original inventor and primary manufacturer, with several regional generic producers and contract manufacturing organizations (CMOs) authorized via licensing agreements, ensuring global supply.

2. What criteria are used to qualify suppliers for QUILLICHEW ER?
Suppliers must demonstrate compliance with cGMP standards, provide robust quality assurance documentation, possess valid regulatory approvals, and pass routine audits conducted by licensing or regulatory authorities.

3. How does regional regulation influence the supply of QUILLICHEW ER?
Regional regulation governs manufacturing standards, licensing, and distribution. Variations can affect supplier qualification, production capacity, and approval processes, impacting the availability in different markets.

4. What are the risks associated with the supply chain of QUILLICHEW ER?
Risks include manufacturing disruptions, raw material shortages, regulatory delays, and logistical challenges—particularly for complex extended-release formulations that require precise manufacturing conditions.

5. How can stakeholders ensure the authenticity and quality of QUILLICHEW ER?
Verifying supply sources through approved vendors, reviewing supplier certifications, conducting regular quality audits, and monitoring supply chain traceability ensure authenticity and quality.

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Sources

1. [1] Pharmaceutical Industry Reports, 2023.
2. [2] U.S. Food and Drug Administration (FDA) Manufacturer Registration Database.
3. [3] European Medicines Agency (EMA) Approved Medicinal Products.
4. [4] Supply Chain Management in Pharmaceuticals, Journal of Pharmacology, 2022.
5. [5] Global API Suppliers Directory, 2023.