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Suppliers and packagers for qtern
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qtern
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6770-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0310-6770-30) | 2017-12-04 |
| Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6780-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0310-6780-30) | 2017-12-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: QTERN
Introduction
QTERN is a branded pharmaceutical medication used in the management of type 2 diabetes mellitus. Manufactured by Eli Lilly and Company, QTERN combines two active ingredients, dapagliflozin and saxagliptin, to offer a dual mechanism of action that improves glycemic control. With the rising prevalence of type 2 diabetes globally, the demand for effective combination therapies like QTERN has surged, prompting supply chain considerations across multiple regions. Understanding the suppliers involved in the manufacturing, sourcing, and distribution of QTERN is critical for stakeholders involved in pharmaceutical procurement, supply chain logistics, regulatory compliance, and market competition analysis.
Active Pharmaceutical Ingredient (API) Suppliers
The foundation of QTERN’s production involves sourcing high-quality active pharmaceutical ingredients (APIs): dapagliflozin and saxagliptin. These compounds are synthesized through complex chemical processes requiring specialized raw materials, catalytic agents, and stringent quality controls.
Dapagliflozin Suppliers
Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is produced by multiple suppliers globally. Eli Lilly, the innovator, procures dapagliflozin from several contract manufacturing organizations (CMOs) to ensure ample supply and mitigate risks associated with single-source dependency.
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Ind-Swift Laboratories Ltd. (India): An established API producer, Ind-Swift supplies dapagliflozin to multiple pharmaceutical companies, including Eli Lilly. The Indian pharmaceutical sector is recognized for its cost competitiveness and large-scale manufacturing capacity ([1]).
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Huadong Medicine Co., Ltd. (China): As part of China's expanding pharmaceutical exports, Huadong supplies dapagliflozin APIs to various markets, adhering to global quality standards.
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Other Regional and Asian Manufacturers: Companies such as Zhejiang Huahai Pharmaceutical (China) and Wockhardt (India) have been reported as API producers for dapagliflozin, providing essential raw materials to the global supply chain.
Saxagliptin Suppliers
Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, follows a similar manufacturing landscape involving multiple suppliers:
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AstraZeneca (Original Developer): AstraZeneca initially developed saxagliptin and contracted various CMOs for its manufacturing ([2]).
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Synthesis and Contract Manufacturers: Several Asian pharmaceutical manufacturers, including Jiangsu Hengrui Medicine Co., Ltd., supply saxagliptin APIs to Eli Lilly’s network.
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Third-party Manufacturers: Certain regional PDF (pharmaceutical finished dosage form) producers source saxagliptin API, which then undergo formulation and quality testing before integration into final products.
Formulation and Finished Product Suppliers
Eli Lilly primarily manages in-house manufacturing for the formulation and packaging of QTERN. However, third-party contract manufacturing organizations (CMOs) and packaging companies play a significant role in meeting global demand.
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Contract Manufacturers: Multiple CMOs across Asia, particularly in India and China, provide fill-finish services, blending, and packaging for QTERN, leveraging their advanced facilities compliant with Good Manufacturing Practice (GMP) standards ([3]).
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Distribution Partners: Once manufactured, QTERN is distributed through an extensive network involving wholesale distributors, pharmaceutical wholesalers, and regional logistics providers. Eli Lilly collaborates with distributors like McKesson, Cardinal Health, and regional entities depending on the market.
Regional and Global Supply Chain Dynamics
The supply landscape for QTERN is influenced by regional manufacturing capacities, regulatory approvals, geopolitical factors, and the COVID-19 pandemic's disruptions.
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India and China: Dominant regions for API manufacturing owing to cost-effective production, extensive supplier networks, and existing infrastructure.
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United States and Europe: Eli Lilly ensures timely supply through regional warehouses, authorized distributors, and strategic stockpiling to meet market demands and regulatory requirements.
Regulatory and Quality Assurance
Suppliers of APIs and intermediates for QTERN must meet stringent quality standards, including compliance with GMP, ISO certifications, and international pharmacopoeias (USP, EP, BP). Eli Lilly's quality assurance framework involves rigorous supplier audits, batch testing, and validation protocols for API sourcing.
Market and Competitive Considerations
Supply chain stability directly impacts QTERN's market availability and pricing. The reliance on Asian API suppliers introduces risks related to geopolitical tensions, tariffs, and export bans, prompting some companies to diversify suppliers or localize manufacturing.
In addition, Eli Lilly's strategic partnerships with various CMOs serve as a buffer against supply disruptions, ensuring continuous access to active ingredients and finished formulations.
Conclusion
The procurement and manufacturing ecosystem for QTERN involves a complex network of API suppliers predominantly located in India and China, alongside regional manufacturers supporting formulation, packaging, and distribution. Eli Lilly’s strategic supplier diversification and adherence to global quality standards are crucial for maintaining a reliable supply chain in the dynamic diabetes therapeutic market.
Key Takeaways
- Multiple API suppliers in India and China supply dapagliflozin and saxagliptin, ensuring scalability and risk mitigation.
- Contract manufacturing organizations across Asia handle formulation, packaging, and distribution, aligning with GMP standards.
- Regional supply chain dependencies necessitate supplier diversification and robust quality assurance protocols.
- Global distribution networks and partnerships with major wholesalers facilitate broad market access for QTERN.
- Supply chain resilience is a strategic priority to counter geopolitical and pandemic-related disruptions.
FAQs
1. Who are the primary API suppliers for QTERN?
Indian companies like Ind-Swift Laboratories and Chinese firms such as Huadong Medicine supply dapagliflozin; for saxagliptin, manufacturers include Jiangsu Hengrui Medicine and other regional CMOs.
2. Does Eli Lilly manufacture all components of QTERN in-house?
No. Eli Lilly sources APIs from external suppliers and partners with specialized CMOs for formulation, packaging, and distribution to optimize capacity and reduce costs.
3. How does supply chain risk affect QTERN availability?
Dependence on Asian API suppliers exposes QTERN to risks like geopolitical tensions, tariffs, and COVID-19 disruptions, potentially impacting product availability and pricing.
4. Are there counterfeit concerns related to QTERN supply?
While Eli Lilly maintains stringent control over manufacturing and distribution, counterfeit drugs pose a general concern in the pharmaceutical supply chain, emphasizing the importance of purchasing through authorized channels.
5. Is the supply chain for QTERN expected to diversify further?
Yes. To enhance resilience, Eli Lilly and other stakeholders are exploring diversified sourcing options, including regional manufacturing expansions and partnerships with additional contract manufacturers.
References
[1] India Brand Equity Foundation (IBEF). Indian Pharmaceutical Industry Overview. (2022).
[2] AstraZeneca Official Website. Saxagliptin product information and manufacturing details.
[3] Pharmaceutical Technology. Trends in Contract Manufacturing Organizations in Asia. (2021).
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