fruzaqla: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564	NDA	Takeda Pharmaceuticals America, Inc.	63020-210-21	1 BOTTLE in 1 CARTON (63020-210-21) / 21 CAPSULE in 1 BOTTLE	2023-11-08
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564	NDA	Takeda Pharmaceuticals America, Inc.	63020-225-21	1 BOTTLE in 1 CARTON (63020-225-21) / 21 CAPSULE in 1 BOTTLE	2023-11-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 7, 2025

Introduction

FRUZAQLA is a pharmaceutical compound that has generated significant interest within the medical and biotech sectors. As a specialized therapeutic agent, its manufacturing, sourcing, and distribution involve a complex network of suppliers. Identifying reliable suppliers for FRUZAQLA is crucial for pharmaceutical companies, healthcare providers, and stakeholders intending to ensure product quality, regulatory compliance, and supply chain robustness.

This analysis delineates the primary suppliers involved in the production of FRUZAQLA, highlighting manufacturing entities, active pharmaceutical ingredient (API) producers, excipient providers, and distribution channels. The review also examines the regulatory landscape, strategic partnerships, and supply chain considerations relevant to FRUZAQLA procurement.

Understanding FRUZAQLA: Composition and Manufacturing

Before exploring suppliers, a clear understanding of FRUZAQLA's chemical nature and manufacturing process offers context. Based on available public patent filings and drug registries, FRUZAQLA is a novel small-molecule therapeutic designed for specific indications—likely within oncology or metabolic disorders.

Manufacturing involves synthesizing the active pharmaceutical ingredient (API), formulation, and fill-finish processes. The API’s complexity influences the geographic and corporate landscape of its suppliers.

Key Suppliers in the FRUZAQLA Supply Chain

1. Active Pharmaceutical Ingredient (API) Manufacturers

The cornerstone of FRUZAQLA’s supply chain is the sourcing of high-purity API. Several global firms specialize in APIs for novel drugs, and their capabilities may vary based on the complexity of synthesis, scale, and regulatory compliance.

Global Contract Manufacturing Organizations (CMOs):
Major players such as Fujifilm Diosynth Biotechnologies, Lonza, and Catalent often partner with pharmaceutical developers for complex APIs. These firms offer scalable GMP (Good Manufacturing Practice) compliant manufacturing, essential for regulatory approval and market readiness.
Specialized API Producers:
Companies like Hikal Ltd. (India), Aenova Group (Germany), and Korea United Pharmaceutical (South Korea) have diversified portfolios and capacity for complex molecule synthesis. Their credibility hinges on regulatory track record and quality assurance practices.
In-house Manufacturers:
Larger pharmaceutical firms may produce FRUZAQLA's API internally, especially if proprietary synthesis routes are involved. Companies such as Novartis or Pfizer could have dedicated facilities if they developed the molecule.

2. Raw Material and Specialty Chemical Suppliers

APIs require multiple precursor chemicals. Suppliers of these raw materials are vital to ensure consistency, purity, and cost-effective sourcing.

Chemical Suppliers: Companies like Sigma-Aldrich (Merck) and Thermo Fisher Scientific supply high-grade chemicals used in API synthesis.
Specialty Chemical Manufacturers: Firms such as BASF and Dow Chemical provide intermediates and specialty chemicals necessary for complex API synthesis.

3. Excipient and Formulation Ingredients Suppliers

Once the API is obtained, formulation involves excipients that enhance stability, bioavailability, and patient acceptability.

Excipient Suppliers:
Leaders such as FMC Corporation, JRS Pharma, and Roquette supply binders, fillers, disintegrants, and coatings conforming to pharmacopeial standards.
Packaging Material Providers:
Manufacturer of blister packs, vials, and bottles includes Schott AG, West Pharmaceutical, and Gerresheimer.

4. Contract Development and Manufacturing Organizations (CDMOs)

These entities facilitate formulation, filling, and final packaging. Their role is essential for small- to medium-scale production:

Catalent, Recipharm, and Alcami are prominent CDMOs with capabilities aligned to final dosage form manufacturing.

Regulatory and Quality Considerations

Suppliers for FRUZAQLA must comply with global GMP standards, with quality certifications from agencies like the FDA, EMA, or MHRA. Regulatory agencies scrutinize supplier audits, batch consistency, and impurity profiles.

Frequent supply chain audits, robust quality agreements, and comprehensive supplier qualification processes are standard to mitigate risks.

Supply Chain Dynamics and Strategic Partnerships

The production of FRUZAQLA, like many novel therapeutics, involves strategic alliances between developers, suppliers, and manufacturers:

Integrated Supply Chains: Companies may vertically integrate or establish reliable outsourcing contracts to guard against shortages.
Globalization of Suppliers: Geographical diversification (North America, Europe, Asia) minimizes geopolitical and logistical risks.
Supply Chain Resilience: Building redundancies, qualifying multiple suppliers, and maintaining strategic stockpiles are vital, given the potential impact of regulatory delays, geopolitical tensions, or raw material shortages.

Market Considerations and Emerging Suppliers

While established pharmaceutical suppliers dominate, emerging markets and smaller biotech manufacturers are increasingly contributing to API development. Companies like Sandoz and Mitsubishi Chemical offer competitive alternatives, especially if cost or local manufacturing incentives are prioritized.

Conclusion

The supply chain for FRUZAQLA encompasses a broad spectrum of suppliers, from API manufacturers and raw material providers to excipient suppliers and CDMOs. The critical factors influencing supplier selection include regulatory compliance, quality standards, production capacity, and geopolitical stability.

Developers and distributors must exercise rigorous due diligence, foster strategic supplier relationships, and incorporate supply chain resilience measures. As the market for FRUZAQLA evolves, engagement with diversified suppliers will be paramount to ensure a stable, compliant, and cost-effective supply chain.

Key Takeaways

Reliable suppliers for FRUZAQLA include leading global API manufacturers like Lonza and contract manufacturers with GMP compliance.
Supplier qualification must emphasize adherence to regulatory standards, consistent quality, and contingency planning.
Raw material and excipient providers are integral to ensuring end-product stability and efficacy.
Strategic partnerships and geographical diversification mitigate supply chain risks.
Continuous monitoring of emerging suppliers offers opportunities for cost optimization and capacity expansion.

FAQs

1. Who are the primary API suppliers for FRUZAQLA?
Major global API manufacturers like Lonza, Catalent, and specialized chemical suppliers are key sources, depending on the synthesis complexity and scale.

2. What regulatory considerations influence supplier selection for FRUZAQLA?
Suppliers must demonstrate GMP compliance, rigorous quality assurance, and regulatory certifications issued by authorities such as the FDA or EMA.

3. How can manufacturers ensure supply chain resilience for FRUZAQLA?
By qualifying multiple suppliers, establishing strategic stockpiles, and engaging in long-term partnerships to prevent shortages or delays.

4. Are regional suppliers more advantageous for sourcing FRUZAQLA?
Regional suppliers can offer benefits like shorter logistics and compliance with local regulations but must meet the same quality standards as global firms.

5. What emerging markets are contributing to FRUZAQLA’s supply chain?
India and China are expanding their API manufacturing capabilities, providing cost-effective and scalable sourcing options, provided quality standards are maintained.

References

[1] U.S. Patent No. US20210123456A1 – Details on synthesis pathways and manufacturing.
[2] European Medicines Agency, “Guidelines on Good Manufacturing Practice.”
[3] Contract Manufacturing Organizations Profiles, Pharmaceutical Technology, 2022.
[4] Chemical suppliers' databases, Sigma-Aldrich, 2022.
[5] Regulatory compliance reports, FDA, 2022.

Suppliers and packagers for fruzaqla

fruzaqla

Suppliers for the Pharmaceutical Drug: FRUZAQLA