GLYXAMBI: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0164-30	30 TABLET, FILM COATED in 1 BOTTLE (0597-0164-30)	2015-01-30
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0164-39	30 BLISTER PACK in 1 CARTON (0597-0164-39) / 1 TABLET, FILM COATED in 1 BLISTER PACK	2015-01-30
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0164-90	90 TABLET, FILM COATED in 1 BOTTLE (0597-0164-90)	2015-01-30
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0182-30	30 TABLET, FILM COATED in 1 BOTTLE (0597-0182-30)	2015-01-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report details the primary suppliers of active pharmaceutical ingredients (APIs) and critical excipients for Glyxambi, a fixed-dose combination drug containing empagliflozin and linagliptin. Understanding this supply chain is crucial for assessing manufacturing reliability, potential for supply disruptions, and cost-optimization strategies.

What Are the Active Pharmaceutical Ingredients in Glyxambi?

Glyxambi's therapeutic efficacy stems from two distinct APIs: empagliflozin and linagliptin.

Empagliflozin: This is a sodium-glucose cotransporter-2 (SGLT2) inhibitor.
Linagliptin: This is a dipeptidyl peptidase-4 (DPP-4) inhibitor.

Both APIs are synthesized through complex multi-step chemical processes.

Who Manufactures Empagliflozin API?

The primary manufacturer of empagliflozin API is Boehringer Ingelheim, the originator company of Glyxambi. However, contract manufacturing organizations (CMOs) play a role in the global supply chain.

Boehringer Ingelheim: As the innovator, Boehringer Ingelheim likely controls significant in-house API production capacity. Their manufacturing sites are typically located in Germany and the United States [1].
Contract Manufacturing Organizations (CMOs): While specific CMOs for empagliflozin are not always publicly disclosed due to commercial confidentiality, major API manufacturers with expertise in complex organic synthesis and handling controlled substances are potential candidates. These include companies in India and China that specialize in advanced intermediates and APIs for global pharmaceutical markets. For instance, companies with strong capabilities in heterocyclic chemistry and glycosylation are relevant for empagliflozin synthesis.

Who Manufactures Linagliptin API?

Similar to empagliflozin, linagliptin API production is primarily associated with Boehringer Ingelheim.

Boehringer Ingelheim: Boehringer Ingelheim maintains internal manufacturing capabilities for linagliptin. Key production facilities are located in Europe [1].
Contract Manufacturing Organizations (CMOs): The global supply chain for linagliptin API also involves CMOs. These organizations are typically selected based on their ability to meet stringent quality standards (e.g., Good Manufacturing Practices - GMP) and possess the necessary technological infrastructure for producing complex small molecules. Companies in Asia, particularly India and China, are significant players in the global API market and could be involved in supplying linagliptin or its key intermediates.

What Are the Critical Excipients for Glyxambi?

Beyond the APIs, Glyxambi formulation requires several excipients to ensure tablet integrity, dissolution, stability, and bioavailability. The specific inactive ingredients can vary slightly based on the formulation and manufacturing site, but common critical excipients include:

Binders: Agents that hold the tablet ingredients together.
- Pregelatinized Starch: Commonly used for its binding properties and compatibility with various APIs.
- Povidone (Polyvinylpyrrolidone): Another effective binder used to improve granule strength and tablet hardness.
Disintegrants: Substances that help the tablet break apart in the digestive tract, facilitating API release.
- Croscarmellose Sodium: A widely used superdisintegrant that rapidly swells upon contact with water.
- Sodium Starch Glycolate: Another effective disintegrant with similar swelling properties.
Diluents (Fillers): Inert substances that add bulk to the tablet, making it a practical size for handling and compression.
- Lactose Monohydrate: A common diluent, though alternatives are used for lactose-intolerant patients.
- Microcrystalline Cellulose (MCC): Provides good compressibility and tablet hardness.
Lubricants: Prevent the tablet ingredients from sticking to the punches and dies during compression.
- Magnesium Stearate: The most common lubricant used in tablet manufacturing.
- Stearic Acid: Used as an alternative or in combination with magnesium stearate.
Glidants: Improve the flowability of the powder mixture before compression.
- Colloidal Silicon Dioxide (Aerosil): Enhances powder flow.
Coating Agents: Applied to the tablet surface for aesthetic appeal, taste masking, or protection.
- Hypromellose (Hydroxypropyl Methylcellulose): A common film-coating agent.
- Titanium Dioxide: Used as an opacifier and white pigment in coatings.
- Macrogol (Polyethylene Glycol): Acts as a plasticizer in film coatings.

Who Are the Key Excipient Suppliers?

The global market for pharmaceutical excipients is diverse, with several large multinational corporations and specialized regional suppliers. The suppliers for Glyxambi's excipients are likely to include leading companies in this sector.

Ashland: A major supplier of binders (e.g., Povidone, Crospovidone) and film-coating agents (e.g., Opadry®).
DuPont (now IFF): Known for microcrystalline cellulose (MCC) under the Avicel® brand, a key diluent and binder.
Evonik Industries: Offers a range of excipients including binders (e.g., Povidone), disintegrants, and solubilizers.
BASF SE: A significant producer of excipients, including Povidone and its derivatives, and Soluplus® (a vinylpyrrolidone-styrene copolymer).
Roquette Frères: A leading producer of starches and derivatives, including pregelatinized starch and sodium starch glycolate.
JRS Pharma: Supplies microcrystalline cellulose and other cellulosic excipients.
Meadowcroft: A supplier of magnesium stearate and stearic acid.
Shin-Etsu Chemical: A global supplier of cellulose derivatives, including Hypromellose.
Croda International: Provides specialty excipients, including polyethylene glycols.

The specific choice of excipient supplier is determined by factors such as regulatory compliance, quality consistency, supply chain reliability, and cost. Boehringer Ingelheim's internal procurement policies and global supply chain management strategies will dictate the exact sourcing for its Glyxambi production.

Regulatory Considerations for API and Excipient Sourcing

The sourcing of APIs and excipients for pharmaceutical manufacturing is subject to rigorous regulatory oversight by health authorities worldwide, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Good Manufacturing Practices (GMP): All API and excipient manufacturers must adhere to GMP standards. This ensures that products are consistently produced and controlled according to quality standards appropriate for their intended use.
Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. These confidential documents contain detailed information about the manufacturing process, quality control, and facility. Drug product manufacturers can then reference these DMFs in their marketing authorization applications.
ICH Guidelines: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, such as ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and ICH Q10 (Pharmaceutical Quality System), provide global standards for API manufacturing.
Excipient Qualification: Pharmaceutical companies must qualify their excipient suppliers to ensure the excipients meet the required quality and safety specifications. This involves audits, testing, and establishing robust supplier agreements. The International Pharmaceutical Excipients Council (IPEC) provides guidelines for excipient manufacturers and users.
Supply Chain Audits: Regular audits of API and excipient manufacturing sites are conducted by the drug product manufacturer to verify ongoing compliance with quality standards and regulatory requirements.
Country of Origin: While not a direct regulatory barrier, the country of origin of APIs and excipients can influence supply chain risk assessment due to geopolitical factors, trade agreements, and differing regulatory enforcement levels.

Supply Chain Risks and Mitigation Strategies

The Glyxambi supply chain, like any pharmaceutical supply chain, faces potential risks that could impact product availability.

Key Supply Chain Risks

Single-Source API Dependence: If a critical API (empagliflozin or linagliptin) is predominantly sourced from a single manufacturer or facility, any disruption at that site (e.g., natural disaster, industrial accident, regulatory action) could lead to shortages.
Geopolitical Instability: Reliance on suppliers in regions prone to geopolitical tension or trade disputes can create supply chain vulnerabilities.
Raw Material Scarcity: Intermediates or raw materials required for API synthesis might experience shortages due to global demand or production issues upstream.
Quality Control Failures: A quality lapse at an API or excipient manufacturing site can lead to product recalls, manufacturing halts, and regulatory sanctions, impacting multiple drug products.
Logistical Challenges: Transportation disruptions, customs delays, or unforeseen changes in shipping routes can affect the timely delivery of components.
Intellectual Property Disputes: Patent expiry or litigation related to manufacturing processes for APIs or critical intermediates could impact established supply chains.
Natural Disasters and Pandemics: Global events like pandemics or severe weather can disrupt manufacturing operations and logistics across multiple suppliers.

Mitigation Strategies

Dual Sourcing: Identifying and qualifying a secondary supplier for critical APIs and excipients can provide a buffer against single-source dependency. This requires significant investment in supplier qualification and ongoing quality assurance.
Geographic Diversification: Sourcing from manufacturers located in different geographic regions can mitigate risks associated with regional instability or natural disasters.
Strategic Inventory Management: Maintaining sufficient buffer stock of critical raw materials, intermediates, and finished APIs can help weather short-term supply disruptions. However, this incurs carrying costs and risks of obsolescence.
Robust Supplier Qualification and Auditing: Implementing stringent supplier selection processes and conducting regular, in-depth audits of manufacturing sites ensures adherence to quality standards and GMP.
Building Strong Supplier Relationships: Collaborative partnerships with key suppliers can foster transparency, early warning of potential issues, and joint problem-solving.
Supply Chain Visibility Tools: Implementing technologies that provide real-time tracking and monitoring of materials throughout the supply chain can improve responsiveness to disruptions.
Contingency Planning: Developing detailed business continuity plans for various disruption scenarios, including alternative sourcing options and communication protocols, is essential.
Process Optimization and Robustness: Ensuring that API and drug product manufacturing processes are inherently robust and well-understood can reduce susceptibility to minor variations in raw materials or operating conditions.

Conclusion on Glyxambi's Supply Chain

The supply chain for Glyxambi is anchored by Boehringer Ingelheim's likely control over its proprietary APIs, empagliflozin and linagliptin. However, the broader ecosystem involves a network of global contract manufacturers for APIs and intermediates, and a diversified set of excipient suppliers. Adherence to stringent GMP regulations and robust supply chain management are paramount for ensuring consistent product quality and availability. Companies involved in the Glyxambi supply chain, whether as direct manufacturers or as service providers, must prioritize risk mitigation through dual sourcing, geographic diversification, and strong quality assurance protocols.

Key Takeaways

Glyxambi's active pharmaceutical ingredients are empagliflozin and linagliptin, primarily manufactured by or for Boehringer Ingelheim.
A range of binders, disintegrants, diluents, lubricants, glidants, and coating agents are essential excipients.
Major global chemical and pharmaceutical ingredient manufacturers like Ashland, IFF, Evonik, BASF, and Roquette are likely suppliers for these excipients.
Regulatory compliance with GMP and submission of DMFs are critical for API and excipient sourcing.
Supply chain risks include single-source dependency, geopolitical instability, and quality control failures, necessitating strategies like dual sourcing and geographic diversification.

Frequently Asked Questions

What is the primary risk associated with empagliflozin API sourcing?

The primary risk is dependence on a limited number of manufacturers, potentially leading to shortages if production is disrupted by regulatory actions, accidents, or geopolitical events.

How does Boehringer Ingelheim ensure the quality of its excipients?

Boehringer Ingelheim employs rigorous supplier qualification processes, conducts regular audits of excipient manufacturers, and performs incoming material testing to verify compliance with predetermined specifications and regulatory standards.

Are there any generic versions of Glyxambi currently available, and how would that impact the API supply chain?

As of the current analysis, Glyxambi (empagliflozin/linagliptin) is under patent protection. The introduction of generic versions would significantly increase demand for empagliflozin and linagliptin APIs, potentially leading to more diversified sourcing and increased competition among API manufacturers.

What is the typical lead time for sourcing critical pharmaceutical excipients?

Lead times for critical pharmaceutical excipients can range from 8 to 24 weeks, depending on the specific material, manufacturer's production schedule, existing inventory, and shipping logistics. Custom or specialized excipients may require longer lead times.

How do fluctuating raw material costs for API synthesis impact Glyxambi's manufacturing costs?

Fluctuations in the cost of raw materials used in the complex synthesis pathways for empagliflozin and linagliptin can directly impact the cost of goods sold for Glyxambi. These costs are a significant factor in overall drug pricing and profitability, and manufacturers may absorb some volatility or pass it on to purchasers.

Citations

[1] Boehringer Ingelheim. (n.d.). Manufacturing & Supply Chain. Retrieved from [Boehringer Ingelheim Corporate Website - Specific details on API manufacturing locations are typically not publicly disclosed in detail but are inferred from general corporate information and public filings regarding their global presence.]

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