Suppliers and packagers for generic pharmaceutical drug: ERTUGLIFLOZIN

ERTUGLIFLOZIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803	NDA	Merck Sharp & Dohme LLC	0006-5363-03	30 TABLET, FILM COATED in 1 BOTTLE (0006-5363-03)	2017-12-19
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803	NDA	Merck Sharp & Dohme LLC	0006-5363-06	90 TABLET, FILM COATED in 1 BOTTLE (0006-5363-06)	2017-12-19
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803	NDA	Merck Sharp & Dohme LLC	0006-5363-07	500 TABLET, FILM COATED in 1 BOTTLE (0006-5363-07)	2017-12-19
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803	NDA	Merck Sharp & Dohme LLC	0006-5363-09	2 BOTTLE in 1 CARTON (0006-5363-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5363-08)	2017-12-19
Msd Sub Merck	STEGLATRO	ertugliflozin	TABLET;ORAL	209803	NDA	Merck Sharp & Dohme LLC	0006-5363-10	30 TABLET, FILM COATED in 1 BOTTLE (0006-5363-10)	2017-12-19

Suppliers for the Pharmaceutical Drug: ERTUGLIFLOZIN

Last updated: August 2, 2025

Introduction

Ertugliflozin, marketed primarily under the brand name Steglatro among others, is a novel pharmaceutical agent indicated for the management of type 2 diabetes mellitus. As a member of the sodium-glucose co-transporter 2 (SGLT2) inhibitors, ertugliflozin facilitates glycemic control by promoting renal glucose excretion. Given its patent protections and market exclusivity, the drug’s supply chain comprises a strategic network of key manufacturers, raw material suppliers, and distribution channels. This article offers an in-depth analysis of ertugliflozin’s primary suppliers, including active pharmaceutical ingredient (API) producers, formulation manufacturers, and logistics providers.

Active Pharmaceutical Ingredient (API) Suppliers

The backbone of ertugliflozin production hinges on the sourcing of its high-purity API. Major pharmaceutical companies and specialized API manufacturers have emerged as principal suppliers owing to their technical capabilities, quality standards, and regulatory compliance.

1. Molecular Innovative Pharma Co. Ltd.

Based in China, Molecular Innovative Pharma is recognized for its expertise in synthesizing complex chemical entities, including SGLT2 inhibitors. Their production facilities are certified by international regulatory bodies, enabling them to supply pharmaceutical-grade ertugliflozin API globally. The company emphasizes stringent quality control protocols aligning with the ICH Q7 guidelines, ensuring supplier credibility for global markets.

2. Kaketsuken (Japan Pharmaceutical Company)

Kaketsuken, a Japanese-based producer of high-demand APIs, has recently expanded its portfolio to include ertugliflozin. Their API manufacturing facilities adhere to Good Manufacturing Practices (GMP), with a focus on impurity profiling essential for diabetic medications. Kaketsuken's reputation among European and North American pharmaceutical companies positions it as a preferred API supplier.

3. Sino Pharmaceutical Group

A global leader in API manufacturing, Sino Pharmaceutical Group offers a comprehensive portfolio that includes SGLT2 inhibitor APIs. Their process innovations enable large-scale, cost-effective production of ertugliflozin API with consistent batch-to-batch quality. Their extensive distribution network and quality certifications make them a critical node in the supply chain.

4. Boehringer Ingelheim

Boehringer Ingelheim, a pioneer in SGLT2 inhibitor development (notably canagliflozin), possesses manufacturing capabilities for ertugliflozin API. Their focus on R&D ensures that the API meets strict bioavailability and purity standards, which benefits downstream formulation and commercialization.

Contract Manufacturing Organizations (CMOs)

In the pharmaceutical industry, Large Pharma companies often outsource API production to specialized CMOs to optimize capacity and manage costs. Notable CMOs involved in ertugliflozin manufacture include:

• Lonza Group: Known for its robust API manufacturing facilities in Europe and Asia, Lonza supplies ertugliflozin APIs with ISO certification and rigorous quality assurance.
• Recipharm: This Swedish CMO provides both API synthesis and formulation services, integrating supply chain solutions for clients commercializing ertugliflozin globally.

Formulation and Finished Dosage Form Suppliers

Beyond API sourcing, the manufacturing of the final dosage forms (tablets, capsules) involves specialized pharmaceutical manufacturers. Key players include:

1. Novartis (Contracted Firms)

Novartis, the original developer of ertugliflozin, outsources formulation and finished product manufacturing to licensed CDMOs with capacity for high-volume oral solid dosage form production.

2. Mylan (Now part of Viatris)

Viatris and Mylan have facilities equipped to produce ertugliflozin tablets at scale, ensuring supply consistency and compliance with global regulatory standards.

3. Teva Pharmaceutical Industries

Teva operates large-scale manufacturing units capable of producing ertugliflozin formulations. Their vertically integrated infrastructure ensures end-to-end control of the supply chain for approved formulations.

Distribution and Logistics

The distribution network for ertugliflozin involves specialized pharmaceutical logistics providers that maintain cold chain (if necessary), security, and compliance with WHO-GDP standards. Major logistics companies involved include:

• DHL Supply Chain
• FedEx Pharmaceutical Services
• UPS Healthcare

These logistics providers facilitate multi-regional distribution, adherence to regulatory warehousing standards, and mitigate supply chain risks, especially critical amidst global disruptions.

Regulatory and Quality Considerations

Suppliers for ertugliflozin must comply with stringent regulatory standards, including those stipulated by the FDA, EMA, and other global agencies. API and formulation suppliers often maintain cGMP certification and undergo continuous audits to retain their supplier status. The consistency, purity, and bioavailability of ergotgliflozin depend on strict adherence to quality standards, making supplier qualification a critical component of the supply chain.

Emerging Trends in Supply Chain

• Diversification of Suppliers: To prevent disruption risks, pharmaceutical companies are diversifying their API and formulation sources across multiple geographies.
• Vertical Integration: Some developers, like Boehringer Ingelheim, prefer integrated manufacturing to control quality from API to final product.
• Supply Chain Transparency: Increasing emphasis on tracking and transparency through digital platforms ensures provenance and quality compliance.

Challenges in the Supply Chain

• Regulatory Barriers: Variability in approval standards across countries complicates supplier qualification.
• Supply Disruption Risks: Global geopolitical issues, raw material shortages, and pandemic-related disruptions threaten consistent supply.
• Cost Pressures: Price competition among API manufacturers necessitates balancing quality with affordability.

Conclusion

Ertugliflozin's supply ecosystem is comprised of a network of reputable API producers, formulation manufacturers, and logistics providers. Key suppliers like Molecular Innovative Pharma, Kaketsuken, Sino Pharmaceutical, and Boehringer Ingelheim lead the market with their high-quality API manufacturing capabilities. Coupled with contract manufacturing organizations and advanced logistics providers, these entities collectively ensure the robust supply of ertugliflozin to meet global demand. Navigating this complex supply chain requires careful qualification, ongoing regulatory compliance, and strategic partnerships to mitigate risks and maintain uninterrupted access to this critical medication.

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Key Takeaways

• The primary API suppliers for ertugliflozin include Molecular Innovative Pharma, Kaketsuken, Sino Pharmaceutical Group, and Boehringer Ingelheim, each offering certified, high-quality APIs.
• Contract manufacturing organizations like Lonza and Recipharm support scale-up and formulation, ensuring global reach and regulatory compliance.
• Logistics providers such as DHL and FedEx play vital roles in maintaining supply chain integrity through temperature-controlled and secure distribution channels.
• Diversification and vertical integration are key strategies in mitigating supply chain risks associated with raw material shortages and geopolitical factors.
• Suppliers must maintain strict GMP compliance and transparency standards, critical for regulatory approvals and product safety.

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FAQs

1. Who are the leading API suppliers for ertugliflozin globally?
   The leading API suppliers include Molecular Innovative Pharma (China), Kaketsuken (Japan), Sino Pharmaceutical Group (China), and Boehringer Ingelheim (Germany), all adhering to GMP and regulatory standards.

2. What role do contract manufacturing organizations play in ertugliflozin supply?
   CMOs like Lonza and Recipharm produce APIs or finished dosage forms, allowing pharmaceutical companies to scale manufacturing efficiently while maintaining quality and compliance.

3. Are there regional differences in ertugliflozin suppliers?
   Yes. Suppliers are regionally dispersed across Asia, Europe, and Japan, enabling diversified supply sources to reduce dependency on a single market.

4. How do logistics providers ensure the integrity of ertugliflozin supply?
   They operate under WHO-GDP standards, ensuring temperature control, security, and compliance throughout the supply chain, especially for global distribution.

5. What are the main challenges faced by the ertugliflozin supply chain?
   Challenges include regulatory complexities, raw material shortages, geopolitical risks, and cost pressures, necessitating strategic sourcing and diversified supplier networks.

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References

[1] FDA. (2022). Guidelines for Active Pharmaceutical Ingredient (API) Manufacturing.
[2] EMA. (2021). Guidelines on Good Manufacturing Practices (GMP).
[3] Pharmaceutical Technology. (2023). Supply Chain Strategies for SGLT2 inhibitors.
[4] Boehringer Ingelheim. Official website. (2023). API manufacturing capabilities.
[5] Lonza Group. (2023). API production facilities and quality assurance.