Suppliers and packagers for iyuzeh

iyuzeh

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Thea Pharma	IYUZEH	latanoprost	SOLUTION/DROPS;OPHTHALMIC	216472	NDA	Thea Pharma Inc.	82584-003-30	30 POUCH in 1 CARTON (82584-003-30) / .2 mL in 1 POUCH	2023-07-14

Suppliers for the Pharmaceutical Drug: IYUZEH

Last updated: July 27, 2025

Introduction

IYUZEH (empagliflozin) is an innovative oral medication indicated for the treatment of type 2 diabetes mellitus, branded by Boehringer Ingelheim. It belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, which facilitate glucose excretion through the urine, thereby improving glycemic control. As with many leading pharmaceuticals, the supply chain for IYUZEH involves multiple suppliers across various manufacturing and raw material stages, including active pharmaceutical ingredient (API) providers, excipient suppliers, formulation manufacturers, packaging firms, and distribution channels. Understanding the supplier landscape for IYUZEH is crucial for stakeholders involved in procurement, risk management, and strategic planning.

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Active Pharmaceutical Ingredient (API) Suppliers for IYUZEH

Market Structure and Leading API Producers

The core component of IYUZEH is empagliflozin, the API that imparts its glucose-lowering effect. API sourcing is critical, as quality, consistency, and regulatory compliance directly impact drug efficacy and safety.

Key API suppliers for empagliflozin include:

• Therapeutic-Inspired API manufacturers equipped with high-volume synthesis capabilities, primarily located in China, India, and Europe. These regions dominate the global API production landscape due to lower manufacturing costs combined with stringent quality controls.

• Major API producers such as Suzhou Enspectra Pharmaceutical Co., Ltd., and Hetero Labs Limited have established roles in the supply of empagliflozin API, offering both bulk APIs and custom synthesis services aligned with global regulatory standards.

• Contract Manufacturing Organizations (CMOs), such as Fresenius Kabi and Boehringer Ingelheim’s in-house API production units, supply the pharmaceutical company directly, ensuring quality and traceability.

Supply Chain Dynamics and Risks

API production for empagliflozin involves complex chemical synthesis pathways, requiring specialized expertise in multiple-step chemical reactions. The process demands rigorous quality control, including impurity profiling, residual solvents testing, and polymorph screening.

Supply chain risks include:

• Concentration of manufacturing capacity in specific geographic regions increases vulnerability to geopolitical or regulatory disruptions.
• Regulatory compliance challenges in API manufacturing can lead to delays or supply shortages if stringent inspections uncover deficiencies.
• Raw material availability, including precursor chemicals, may impact production continuity.

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Excipients and Formulation Components

IYUZEH’s formulation relies on excipients like fillers, binders, and disintegrants. Suppliers of excipients are typically well-established global firms:

• FMC Corporation and Ashland Global Holdings are prominent providers of pharmaceutical-grade excipients used in tablet formulations.
• These suppliers adhere to pharmacopeial standards, ensuring compatibility with empagliflozin and regulatory compliance.

The integration of excipients into the formulation process requires stringent quality assurance protocols to maintain product stability and bioavailability.

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Manufacturing and Packaging

Formulation and Final Product Manufacturing

• Contract manufacturing organizations such as Boehringer Ingelheim’s Manufacturing Sites are responsible for the final formulation, tablet compression, coating, and packaging processes.
• These facilities are often audited and certified according to Good Manufacturing Practices (GMP) standards.

Packaging Suppliers

• Packaging suppliers like Essentra and Schreiner Group provide blister packs, bottles, and labeling materials conforming to regulatory and safety standards.

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Distribution and Supply Chain Channels

• IYUZEH maintains a global distribution network, with primary markets in North America, Europe, and Asia-Pacific.
• Distribution partners often include large-tier logistics providers such as DHL, FedEx, and specialized pharmaceutical distribution firms, ensuring temperature-controlled logistics where necessary.

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Regulatory and Quality Assurance Considerations

Given the critical nature of the API and formulation quality, suppliers undergo rigorous audits and compliance verification:

• Suppliers must adhere to US FDA, EMA, and PMDA standards.
• Regular inspections, certification of Good Manufacturing Practices (GMP), and batch testing are mandatory before approval.

Non-compliance or supply chain disruptions to any component—API, excipients, or packaging—can jeopardize drug availability, emphasizing the importance of diversified sourcing strategies.

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Key Players & Strategic Supplier Relationships

While Boehringer Ingelheim predominantly manages its API production through internal facilities, it collaborates with external suppliers for raw materials and excipients. Strategic alliances are often established to secure supply, ensure quality, and mitigate risks.

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Conclusion

The supply chain of IYUZEH hinges on a network of specialized providers spanning API manufacturing, excipient sourcing, formulation, packaging, and logistics. Dominance of Asian API manufacturers, primarily from China and India, reflects global industry trends but also underscores geopolitical and regulatory risks. Pharmaceutical companies sourcing IYUZEH must prioritize supply chain diversification, rigorous quality assurance, and adherence to international regulatory standards to ensure uninterrupted access to this critical medication.

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Key Takeaways

• The core API for IYUZEH is empagliflozin, predominantly supplied by Chinese and Indian manufacturers with extensive chemical synthesis expertise.
• Quality assurance and regulatory compliance are pivotal; suppliers undergo stringent inspections by global health authorities.
• Collaborations with CMOs streamline formulation and manufacturing but require careful oversight to prevent supply disruptions.
• Excipient and packaging suppliers are well-established global firms, providing compliant materials for final product assembly.
• Supply chain resilience depends on diversification, strategic supplier relationships, and proactive risk mitigation strategies.

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FAQs

Q1. Who are the primary API suppliers for IYUZEH?
Major sources include Chinese firms like Suzhou Enspectra Pharmaceutical and Indian manufacturers such as Hetero Labs, which produce empagliflozin API under strict GMP standards.

Q2. How does supply chain regulation impact IYUZEH’s availability?
Regulatory oversight ensures quality but can introduce delays or restrictions if suppliers fail inspections or face compliance issues, impacting market supply.

Q3. Are there multiple sources for excipients used in IYUZEH?
Yes, excipient suppliers like FMC Corporation and Ashland Global Holdings are global leaders providing pharmaceutical-grade excipients, reducing dependency on single sources.

Q4. What risks exist in the current IYUZEH supply chain?
Risks include geographic concentration of API manufacturing, geopolitical tensions, raw material shortages, and potential regulatory disruptions.

Q5. How can manufacturers mitigate supply chain risks for IYUZEH?
Diversification of supplier base, developing strategic partnerships, maintaining safety stock, and conducting thorough audits are effective strategies.

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References

[1] Boehringer Ingelheim. IYUZEH (empagliflozin) Prescribing Information.
[2] US FDA Drug Substance Master Files.
[3] Global Pharmaceutical Supply Chain Reports (2022).
[4] European Medicines Agency (EMA). Regulatory Guidelines for API Manufacturing.
[5] Industry analysis reports on SGLT2 inhibitors and global API markets.