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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806	NDA	Merck Sharp & Dohme LLC	0006-5369-03	60 TABLET, FILM COATED in 1 BOTTLE (0006-5369-03)	2017-12-19
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806	NDA	Merck Sharp & Dohme LLC	0006-5369-06	180 TABLET, FILM COATED in 1 BOTTLE (0006-5369-06)	2017-12-19
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806	NDA	Merck Sharp & Dohme LLC	0006-5369-07	500 TABLET, FILM COATED in 1 BOTTLE (0006-5369-07)	2017-12-19
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

SEGLUROMET is a proprietary combination medication primarily used to manage type 2 diabetes mellitus. It combines two active ingredients: empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide. This dual mechanism acts synergistically to improve glycemic control. As with many complex pharmaceuticals, the supply chain involves multiple specialized manufacturers—including active pharmaceutical ingredient (API) producers, finished drug manufacturers, and distribution entities. Understanding the current landscape of suppliers for SEGLUROMET is critical for stakeholders, including healthcare providers, investors, and regulatory agencies, to assess supply security, contingency planning, and market dynamics.

Component Overview of SEGLUROMET

Active Pharmaceutical Ingredients (APIs)

Empagliflozin:
- Proprietarily developed by Boehringer Ingelheim, it was first authorized for sale in various markets, including the US and EU. The API production involves complex synthetic pathways requiring high purity standards.
Metformin:
- An older, widely manufactured generic API with a broad base of suppliers globally.

Finished Product Manufacturing

The final formulation involves combining empagliflozin and metformin into a single tablet, adhering to stringent quality standards and regulatory approvals.

Distribution Channels

Once manufactured, SEGLUROMET is distributed through licensed pharmaceutical distributors, often managed by the original innovator company or authorized regional partners.

Major API Suppliers for SEGLUROMET

Empagliflozin Suppliers

Empagliflozin’s complex synthesis and high purity requirements limit the number of dedicated API manufacturers. Boehringer Ingelheim retains exclusive or primary control over its empagliflozin production, but some secondary suppliers have emerged to meet global demand:

Boehringer Ingelheim
As the patent holder, Boehringer Ingelheim manufactures empagliflozin API predominantly in-house, with facilities located in Germany, the US, and Japan. They control the quality, supply, and distribution of the API.
Secondary Suppliers
Due to active pharmaceutical ingredient outsourcing norms and the globalized API market, several Chinese and Indian API manufacturers have expressed interest or obtained approvals to produce empagliflozin APIs, such as:
- Hetero Labs (India)
- Mitsubishi Tanabe Pharma (Japan)
- Other regional producers with regulatory approvals in specific markets (e.g., China Food and Drug Administration (CFDA) approved APIs).
The exclusivity of empagliflozin supply has been critical—any disruption might impact the manufacturing of SEGLUROMET.

Metformin Suppliers

Metformin is among the most widely produced APIs globally, with several large-scale producers:

Viatris (formerly Mylan and Pfizer APIs)
Lupin Ltd. (India)
Sun Pharmaceutical Industries Ltd. (India)
Hetero Labs (India)
Zhejiang Huahai Pharmaceutical (China)

These manufacturers produce both generic and branded metformin APIs, often in multi-ton quantities, and supply to global markets.

Finished Drug Manufacturing and Key Players

Pharmaceutical companies that produce and market SEGLUROMET generally source APIs from the aforementioned suppliers. Notably:

Boehringer Ingelheim: As the originator, they manufacture SEGLUROMET primarily through their own facilities or through exclusive contract manufacturing arrangements with qualified third parties.
Authorized Contract Manufacturers: Several regional manufacturers licensed by Boehringer Ingelheim may produce the final product to meet regional regulatory standards (e.g., FDA, EMA, PMDA).

Supply Chain and Distribution

The global supply chain for SEGLUROMET involves:

API procurement: Tied to the capacity and stability of empagliflozin and metformin suppliers.
Manufacturing: A small pool of approved contract manufacturers handles the final formulation.
Distribution: Licensed wholesalers and pharmacies across North America, Europe, and Asia.

Supply disruptions can originate from geopolitical issues, manufacturing delays, quality concerns, or raw material shortages, especially impacting empagliflozin.

Challenges and Risks in the Supply Chain

API Production Complexity: Empagliflozin’s complex synthesis limits the number of reliable manufacturers, heightening supply vulnerability.
Regulatory Changes: Stricter standards and manufacturing approvals can cause delays or deter new entrants.
Geopolitical Factors: Trade tensions, export restrictions, or regional crises influence API availability.
Raw Material Shortages: Suppliers of key raw materials, especially in China and India, could impact production timelines.

Strategic Implications for Stakeholders

Investors: Dependency on limited empagliflozin suppliers emphasizes importance of diversified procurement strategies.
Manufacturers: Should consider multiple API supplier relationships and maintain high-quality standards to mitigate risks.
Regulators and Distributors: Require robust monitoring mechanisms for supply chain risks to prevent shortages.

Conclusion

The supply ecosystem for SEGLUROMET hinges chiefly on a small number of high-precision API manufacturing units, notably for empagliflozin. While traditional large players dominate metformin API production globally, empagliflozin’s proprietary synthesis limits supplier diversity. Any disruptions in this tightly managed supply chain could have consequential impacts on global availability. Business stakeholders must prioritize supply chain resilience, monitor regulatory environments, and cultivate supplier relationships.

Key Takeaways

The primary suppliers for empagliflozin are Boehringer Ingelheim and select licensed third-party manufacturers, with limited diversification due to complex synthesis.
Metformin API is widely accessible with multiple global producers, reducing supply risk for this component.
Manufacturing and supply chain stability of SEGLUROMET depend heavily on the continuous, reliable production of empagliflozin API.
Regional geopolitical issues and raw material shortages pose significant risks to supply continuity.
Multiplying supplier relationships and maintaining strategic inventories can mitigate potential shortages.

FAQs

1. Who are the main API suppliers for empagliflozin used in SEGLUROMET?
Primarily Boehringer Ingelheim produces empagliflozin API in-house. Several Indian and Japanese manufacturers have obtained approval or developed capacity to supply secondary sources, but Boehringer maintains predominant control over its production.

2. Is there potential for supply shortages of SEGLUROMET due to API constraints?
Yes. The complex synthetic pathway for empagliflozin limits the number of reliable suppliers, raising the risk of shortages if supply chain disruptions occur.

3. Can generic manufacturers produce SEGLUROMET without API sourcing from the originator?
Only if they acquire necessary licensing agreements and API manufacturing approvals, ensuring compliance with quality standards. The potential exists, but it depends on regulatory and patent considerations.

4. What measures do manufacturers take to ensure continuous supply of SEGLUROMET?
They often diversify API suppliers, hold strategic inventories, and develop contingency plans with alternate manufacturing sites.

5. How does regional regulation impact the supply of SEGLUROMET?
Regulatory approvals from regional agencies like the FDA, EMA, or CFDA influence manufacturing authorizations, quality standards, and can either facilitate or restrict API and finished product availability.

Citations:

[1] Boehringer Ingelheim. (2022). Empagliflozin patent and manufacturing details.
[2] US Food and Drug Administration. (2023). Approved APIs and manufacturing facilities.
[3] Indian Pharmaceutical Industry Reports. (2022). API manufacturing capacity and stakeholders.

Suppliers and packagers for SEGLUROMET

SEGLUROMET

Suppliers for the Pharmaceutical Drug: SEGLUROMET