Suppliers and packagers for JARDIANCE

JARDIANCE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0152-07	1 BOTTLE in 1 CARTON (0597-0152-07) / 7 TABLET, FILM COATED in 1 BOTTLE	2014-08-01
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0152-30	30 TABLET, FILM COATED in 1 BOTTLE (0597-0152-30)	2014-08-01
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0152-37	30 BLISTER PACK in 1 CARTON (0597-0152-37) / 1 TABLET, FILM COATED in 1 BLISTER PACK	2014-08-01
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0152-90	90 TABLET, FILM COATED in 1 BOTTLE (0597-0152-90)	2014-08-01

Comprehensive Analysis of Suppliers for the Pharmaceutical Drug Jardiance

Jardiance (empagliflozin), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has emerged as a critical therapeutic agent for managing type 2 diabetes and reducing cardiovascular risks. Developed through a collaboration between Boehringer Ingelheim and Eli Lilly and Company, Jardiance’s global supply chain involves a complex network of active pharmaceutical ingredient (API) manufacturers, finished dosage form (FDF) producers, and distributors. This report examines the key players in Jardiance’s supply chain, analyzes pricing dynamics, explores regulatory considerations, and evaluates strategies for affordability. With over 125 suppliers identified worldwide, the ecosystem supporting Jardiance’s production highlights the intersection of innovation, globalization, and patient access in modern pharmaceuticals[1][3][9][10][17][18].

Key Manufacturers and Strategic Collaborations

Boehringer Ingelheim and Eli Lilly’s Partnership

Boehringer Ingelheim, a German pharmaceutical giant with over 50,000 employees, spearheads Jardiance’s development and commercialization. The company’s expertise in metabolic diseases and cardiovascular therapies aligns with Jardiance’s dual indications for glycemic control and cardiovascular risk reduction[2][5][12][14][20][22]. Eli Lilly and Company, a U.S.-based leader in diabetes care, complements this partnership through its extensive distribution networks and historical innovations, such as the polio vaccine. Together, these firms navigate regulatory landscapes and clinical trials, ensuring Jardiance meets global standards for safety and efficacy[2][5][12][14][20][22].

Vertical Integration and Manufacturing Standards

Both companies adhere to Good Manufacturing Practices (GMP), with Boehringer Ingelheim’s facilities in Germany and Eli Lilly’s global sites undergoing rigorous FDA and EMA inspections. The EMA’s assessment report emphasizes stability testing and quality control measures, including HPLC-based assays and dissolution tests, to ensure batch consistency[19]. This collaboration underscores the strategic importance of combining R&D prowess with scalable production capabilities.

API Suppliers and Global Supply Chain Dynamics

Major API Manufacturers

Jardiance’s API, empagliflozin, is synthesized by over 94 suppliers worldwide, with significant contributions from Indian and European companies. Polpharma, a Polish contract development and manufacturing organization (CDMO), stands out for its high-volume API production, supplying intermediates to Boehringer Ingelheim’s formulation plants[1][9][10][17][18]. Metrochem API Private Limited, an Indian manufacturer, operates six facilities dedicated to APIs and intermediates, emphasizing cost-efficiency and customization[1][10]. Similarly, Cohance Lifesciences offers end-to-end CDMO services, supporting Jardiance’s lifecycle from development to commercialization[1][9][10][17][18].

Regional Specializations and Regulatory Compliance

Rochem International Inc. leverages its China-based sourcing network to provide cost-effective raw materials, while Dr. Reddy’s Laboratories and Granules India Limited ensure compliance with U.S. Drug Master Files (DMF) and European CEP certifications[1][9][10][17][18]. These suppliers navigate complex regulatory environments, such as the FDA’s requirements for repackaging and relabeling, to maintain market access[3][17].

Pricing Strategies and Affordability Initiatives

Retail Price Variations and Discount Programs

In the U.S., Jardiance’s retail price ranges from $649.68 to $726.70 per month, with SingleCare coupons reducing costs to $452.00–$538.02[7]. Kroger Pharmacy offers the lowest discounted price at $452.00, reflecting competitive pricing strategies among pharmacies[7]. Boehringer Ingelheim’s patient assistance program (PAP) further alleviates costs for uninsured patients, with eligibility criteria based on income and insurance status[6][15][23].

International Cost Disparities and Generic Alternatives

While the U.S. faces high branded drug prices, international markets benefit from generic empagliflozin. Indian companies like Lupin Pharmaceuticals offer generic versions at $5.50 per month, though these are not FDA-approved for the U.S. market[8][16][24]. Online pharmacies, operating with lower overheads, provide savings of up to 10% on branded Jardiance, though patients must verify licensure and authenticity[8][16][24].

Regulatory Landscape and Patent Considerations

Patent Expiration and Market Implications

Jardiance’s composition patent expires in December 2025, opening pathways for generic competition in the U.S.[21]. The NCE-1 date marks the earliest opportunity for ANDA filings, likely triggering price reductions and market expansion. Indian API manufacturers, already producing generics for non-U.S. markets, are poised to capitalize on this shift[21].

Quality Assurance and Global Standards

The EMA’s 2014 assessment report outlines stringent stability protocols, with 36-month longitudinal studies confirming the drug’s integrity under varied storage conditions[19]. API suppliers must align with ICH Q6A guidelines, ensuring microbial quality and dissolution performance meet pharmacopeial standards[19].

Conclusion and Future Directions

Jardiance’s supply chain exemplifies the pharmaceutical industry’s reliance on globalized production and strategic partnerships. As patent expiration looms, the role of API suppliers in India and Europe will expand, potentially lowering costs and improving access. Patients, meanwhile, benefit from evolving affordability programs and digital pharmacies, though vigilance against counterfeit products remains critical.

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Key Takeaways

1. Collaborative Innovation: Boehringer Ingelheim and Eli Lilly’s partnership drives Jardiance’s clinical and commercial success.
2. Global Supplier Network: Over 125 API suppliers, led by Polpharma and Metrochem, ensure robust production scalability.
3. Cost Dynamics: Price variations between U.S. and international markets highlight opportunities for savings via coupons and generics.
4. Regulatory Preparedness: Suppliers must navigate patent expirations and GMP standards to maintain market access.
5. Patient-Centric Access: PAPs and online platforms bridge affordability gaps, though quality assurance is paramount.

Frequently Asked Questions

What companies manufacture generic Jardiance?
Generic empagliflozin is produced by Lupin, Dr. Reddy’s, and other Indian firms, though these are not available in the U.S. due to patent restrictions[8][16][24].

How can I reduce Jardiance costs in the U.S.?
Utilize manufacturer coupons, insurance rebates, or patient assistance programs, which can lower monthly expenses to under $50 for eligible individuals[6][7][15][23].

Who are the primary API suppliers for Jardiance?
Polpharma, Metrochem API, and Cohance Lifesciences are key suppliers, adhering to FDA and EMA quality standards[1][3][9][10][17][18].

When will generic Jardiance be available in the U.S.?
Generic versions may enter the U.S. market post-December 2025, following patent expiration and ANDA approvals[21].

What regulatory challenges do Jardiance suppliers face?
Suppliers must comply with GMP, DMF filings, and stability testing protocols to ensure batch consistency and regulatory compliance[3][19].

References

1. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/jardiance
2. https://www.clinicaltrialsarena.com/marketdata/jardiance-treatment-type-2-diabetes/
3. https://www.pharmacompass.com/manufacturers-suppliers-exporters/jardiance
4. https://pharmaserve.com/pharmacy_drugs/jardiance/
5. https://www.mydrugcenter.com/blog/jardiance/jardiance-manufacturer
6. https://nowpatient.com/blog/where-to-find-affordable-jardiance
7. https://www.singlecare.com/prescription/jardiance
8. https://wirelesslifesciences.org/2023/10/jardiance/
9. https://www.pharmacompass.com/manufacturers-suppliers-exporters/jardiance
10. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/jardiance
11. https://www.apisourcing.net/statistics/new-listed-api-manufacturers/
12. https://www.mydrugcenter.com/blog/jardiance/jardiance-manufacturer
13. https://bulkdrugsdirectory.com/top-20-pharma-api-manufacturers-in-india/
14. https://www.clinicaltrialsarena.com/marketdata/jardiance-treatment-type-2-diabetes/
15. https://nowpatient.com/blog/where-to-find-affordable-jardiance
16. https://wirelesslifesciences.org/2023/10/jardiance/
17. https://www.pharmacompass.com/manufacturers-suppliers-exporters/jardiance
18. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/jardiance
19. https://www.ema.europa.eu/en/documents/assessment-report/jardiance-epar-public-assessment-report_en.pdf
20. https://www.mydrugcenter.com/blog/jardiance/jardiance-manufacturer
21. https://pharsight.greyb.com/drug/jardiance-patent-expiration
22. https://www.clinicaltrialsarena.com/marketdata/jardiance-treatment-type-2-diabetes/
23. https://nowpatient.com/blog/where-to-find-affordable-jardiance
24. https://wirelesslifesciences.org/2023/10/jardiance/