Last updated: July 29, 2025
Introduction
Jardiance (empagliflozin) is a leading medication used for managing type 2 diabetes mellitus and reducing cardiovascular risk in affected patients. Developed by Boehringer Ingelheim and Eli Lilly, Jardiance belongs to the class of SGLT2 (sodium-glucose co-transporter 2) inhibitors. Its global demand has surged, prompting an intricate supply chain involving multiple suppliers for active pharmaceutical ingredients (API), excipients, and formulation components. This report provides an in-depth analysis of the key suppliers underpinning Jardiance’s manufacturing ecosystem, including API producers, excipients, and formulation materials, along with the strategic implications for stakeholders.
Active Pharmaceutical Ingredient (API) Suppliers for Empagliflozin
Overview of API Manufacturing
Empagliflozin's synthesis is complex, involving multiple chemical processes, chiral centers, and proprietary manufacturing technology. Leading pharmaceutical manufacturers rely on a diverse network of API suppliers to meet global demand.
Major API Suppliers
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Celanese Corporation:
Celanese is among the notable producers of empagliflozin API, offering advanced chemical intermediates and final API. Their capabilities include high-volume batch manufacturing compliant with cGMP standards, serving major pharmaceutical firms.
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Hepalink:
Based in China, Hepalink is a prominent API supplier specializing in glycosylated compounds. They supply empagliflozin API to global markets, leveraging cost advantages and robust production facilities.
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Sino Biopharmaceutical Limited:
This Hong Kong-listed firm sources empagliflozin APIs, primarily serving Asian markets and expanding into Western regions. Their infrastructure supports large-scale production with rigorous quality control.
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Mochida Pharmaceutical Co.:
A Japanese manufacturer supplying high-purity empagliflozin API, with a focus on quality standards suitable for US and European markets.
Emerging API Suppliers
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LG Chem:
South Korea-based LG Chem has established capabilities in SGLT2 inhibitor API production, aiming to diversify its portfolio amid rising demand.
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Shandong Lukang Pharmaceutical Co.:
A Chinese API producer increasing its market share with competitive pricing and compliance with international standards.
Strategic Considerations
- Regulatory Compliance: Suppliers require rigorous adherence to global GMP standards (USFDA, EMA), influencing sourcing decisions.
- Supply Chain Security: Geopolitical tensions and trade policies motivate manufacturers to diversify suppliers to mitigate risks.
- Quality and Consistency: Emphasis on high-purity APIs impacts supplier selection, especially for markets with stringent regulation.
Excipients and Formulation Components
Key Excipients
Jardiance formulations involve excipients such as microcrystalline cellulose, magnesium stearate, and polysorbates, supplied by:
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DuPont Tate & Lyle:
Supplies pharmaceutical-grade cellulose and starch derivatives, critical for tablet manufacturing.
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Ajinomoto Co.:
Provides pharmaceutical-grade magnesium stearate used as a lubricant.
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BASF SE:
Supplies surfactants and stabilizers, including polysorbates, for consistent drug delivery.
Formulation Material Suppliers
In addition to excipients, the manufacturing process relies on suppliers of bulk packaging, sterilization components, and coating materials, often sourced locally or regionally depending on the manufacturing site.
Contract Manufacturing Organizations (CMOs) and Production Partners
While primary API and excipient suppliers form the backbone, large pharmaceutical firms often engage CMOs for commercialization, including:
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Samsung Biologics (South Korea):
Known for high-volume API and formulation manufacturing, supporting Jardiance’s global reach.
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Lonza (Switzerland):
Offers comprehensive contract manufacturing, especially for complex oral solid formulations.
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Samsung BioLogics and WuXi AppTec:
Both provide API synthesis and formulation services to ensure scalability and compliance.
Supply Chain Dynamics and Risks
The supply chain for Jardiance is characterized by interdependence across vendors across different regions, especially with significant reliance on Chinese and Indian pharmaceutical ingredients manufacturers. The ongoing geopolitical tensions and pandemic-related disruptions have emphasized necessity for supply chain resilience.
Proactive strategies include dual sourcing, regional manufacturing expansion, and technology transfer agreements to secure continuous supply.
Regulatory and Quality Assurance
Suppliers of empagliflozin API and formulation components must maintain strict compliance with international quality standards. Regulatory agencies such as the USFDA, EMA, and WHO conduct audits and require detailed documentation, influencing supplier selection and operational practices.
Conclusion
The Jardiance supply chain is underpinned by a diversified network of API manufacturers, excipient providers, and CMOs. Leading API suppliers include Celanese, Hepalink, and Sino Biopharmaceutical, with regional players like Mochida, LG Chem, and Lukang serving specific markets. Excipients from DuPont, Ajinomoto, and BASF are integral to formulation stability and efficacy. Strategic supply chain management, regulatory compliance, and quality assurance are critical for maintaining Jardiance’s global availability.
Key Takeaways
- Diversify API sources to mitigate geopolitical and supply chain risks, especially from China and India.
- Prioritize quality standards in selecting suppliers to ensure regulatory compliance and product efficacy.
- Leverage regional manufacturing capabilities to reduce lead times and logistical vulnerabilities.
- Maintain transparency and traceability across the supply chain to facilitate regulatory audits and quality assurance.
- Invest in strategic partnerships with CMOs for scalable manufacturing aligned with changing global demands.
FAQs
1. Who are the top API suppliers for Jardiance (empagliflozin)?
Major API suppliers include Celanese Corporation, Hepalink (China), Sino Biopharmaceutical Limited, Mochida Pharmaceutical, and emerging players like LG Chem.
2. What regions dominate empagliflozin API production?
Primarily Asia-Pacific, notably China and India, supplemented by manufacturers in Japan, South Korea, and select European entities.
3. How do supply chain risks impact Jardiance availability?
Disruptions in API or excipient sourcing can lead to manufacturing delays, shortages, and increased costs, emphasizing the need for diversified sourcing strategies.
4. Are there alternative suppliers for Jardiance’s excipients?
Yes, suppliers such as DuPont, Ajinomoto, and BASF supply key excipients, offering flexibility in procurement.
5. What is the role of CMOs in Jardiance’s manufacturing?
CMOs handle large-scale API synthesis, formulation, and finished drug manufacturing, enabling companies to scale production efficiently while ensuring regulatory compliance.
Sources:
[1] European Medicines Agency. Empagliflozin (Jardiance) Summary.
[2] Boehringer Ingelheim Corporate Website. Product Pipeline.
[3] U.S. Food and Drug Administration. Approved Drugs & API Suppliers.
[4] Market research reports on SGLT2 inhibitor APIs.
[5] Company filings and industry news on API and excipient suppliers.
