Bulk Pharmaceutical API Sources for JENTADUETO XR

Bulk Pharmaceutical API Sources for JENTADUETO XR

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-7C00943
AKos Consulting & Solutions		AKOS040752579
RR Scientific		R6404807
TargetMol		T32758
Biorbyt		orb1985859

Bulk Active Pharmaceutical Ingredient (API) Sources for Jentadueto XR

Last updated: July 30, 2025

Introduction

Jentadueto XR is a branded combination medication containing linagliptin and metformin extended-release (XR), primarily prescribed to manage type 2 diabetes mellitus. Its formulation combines a dipeptidyl peptidase-4 (DPP-4) inhibitor with an extended-release form of metformin, addressing glycemic control through complementary mechanisms. Ensuring reliable sourcing of high-quality APIs—linagliptin and metformin XR—is critical for pharmaceutical manufacturers, generic producers, and supply chain stakeholders intending to replicate, distribute, or reformulate Jentadueto XR.

Overview of API Components

• Linagliptin: A selective, potent DPP-4 inhibitor with a chemical name 7-[(3-aminopiperidin-1-yl) methyl]-3-ethyl-8-[(3R)-3-aminopiperidin-1-yl]-7H-purine-2,6-dione. The API is synthesized via multi-step processes requiring high purity and stereoselectivity.
• Metformin XR: An extended-release formulation of metformin, chemically known as 1,1-dimethylbiguanide. Its manufacturing involves complex crystallization and controlled-release technologies to ensure consistent pharmacokinetics.

Global API Suppliers for Linagliptin

1. Hanmi Pharmaceutical (South Korea)

Hanmi Pharmaceuticals pioneered the development of linagliptin and is one of the primary patent holders. The company produces bulk APIs for in-house use and for licensing partners, with facilities compliant with GMP standards (e.g., US FDA, EMA). Hanmi’s mature manufacturing process ensures high purity and consistent supply, making it a top-tier source for licensed API use.

2. Boehringer Ingelheim (Germany)

As the original developer of linagliptin, Boehringer Ingelheim supplies bulk API primarily for its proprietary formulations and licensed partners. The company maintains extensive manufacturing capabilities in Germany and other locations, emphasizing rigorous quality control, traceability, and GMP compliance.

3. Zhejiang Hisun Pharmaceutical (China)

One of China's leading pharmaceutical manufacturers, Hisun produces APIs, including linagliptin, under strict GMP standards. Their production meets international quality benchmarks, and they actively export globally, providing a cost-effective alternative for generic developers.

4. Amneal Pharmaceuticals (USA)

Amneal is a U.S.-based generics manufacturer with API manufacturing facilities approved by regulatory authorities. Their capabilities include synthesizing highly pure APIs through established processes, supporting both generic drug production and contract manufacturing.

Global API Suppliers for Metformin XR

1. Lupin Limited (India)

Lupin is a recognized leader in metformin API production, with multiple manufacturing plants certified by US FDA and other agencies. The company produces both immediate-release and extended-release formulations, leveraging advanced crystallization and controlled-release technologies for XR versions.

2. Hikma Pharmaceuticals (UK)

Hikma manufactures high-quality metformin XR APIs suitable for generic formulations. Their facilities conform to international GMP standards, and their APIs meet rigorous pharmacopeial specifications, ensuring consistency and efficacy.

3. Teva Pharmaceutical Industries (Israel)

Teva, a major global generic pharmaceutical company, supplies metformin XR APIs produced in GMP-compliant facilities, with extensive experience in extended-release formulations requiring complex formulation technology.

4. Sun Pharmaceutical Industries (India)

Sun Pharma produces metformin XR APIs meeting global standards, emphasizing high purity and consistent pharmacokinetic profiles. Their large-scale manufacturing infrastructure supports stable supply chains.

API Quality and Regulatory Compliance

For APIs intended for Jentadueto XR manufacturing or generic equivalents, adherence to pharmacopoeial standards (e.g., USP, EP, JP) and GMP regulations is mandatory. Suppliers must demonstrate robust quality control systems, batch-to-batch consistency, and traceability. Regulatory approvals or filings (e.g., Drug Master Files—DMFs) further attest to API quality, which is critical for regulatory compliance and market approval.

Supply Chain Considerations

• Geographical diversity mitigates geopolitical and supply disruptions. Developing relationships with multiple suppliers across regions (Asia, Europe, Americas) enhances supply chain resilience.
• Manufacturing capacity and scalability are critical to meeting demand surges, especially considering the global prevalence of type 2 diabetes.
• Intellectual property and licensing influence sourcing, as patent protections restrict API manufacturing for certain compositions, notably linagliptin, which is under patent protection in many regions.

Emerging Trends and Future Outlook

Advancements in synthesis technologies, such as continuous manufacturing and green chemistry, are streamlining API production, reducing costs, and improving sustainability. The rise of biosimilar and generic markets for diabetes medications increases demand for high-quality APIs, fostering competition and innovation among API producers.

Conclusion

Sourcing bulk APIs for Jentadueto XR involves strategic selection of suppliers capable of delivering high-quality, regulatory-compliant APIs at scale. Leading manufacturers like Hanmi Pharmaceutical, Boehringer Ingelheim, Lupin, and Sun Pharma dominate production landscapes, providing reliable sources for linagliptin and metformin XR. Collaborating with established API manufacturers ensures consistent drug quality, regulatory compliance, and supply chain robustness.

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Key Takeaways

• High-quality GMP-certified API suppliers are integral to producing effective and regulatory-compliant Jentadueto XR generics and branded formulations.
• Top-tier API sources for linagliptin include Hanmi Pharmaceutical, Boehringer Ingelheim, Zhejiang Hisun, and Amneal.
• Leading metformin XR API manufacturers include Lupin, Hikma, Teva, and Sun Pharma.
• Diversified supplier relationships mitigate risks related to geopolitical instability, manufacturing disruptions, and demand fluctuations.
• Regulatory diligence, including validation of APIs against pharmacopeial standards and review of DMFs, safeguards product quality and market approval.

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FAQs

1. What are the primary considerations when sourcing APIs for Jentadueto XR?
Manufacturers must prioritize GMP compliance, API purity (typically >99%), consistent manufacturing processes, regulatory approvals, and supply chain stability.

2. Are there regional differences in API quality standards?
Yes. While most reputable suppliers adhere to international standards (USP, EP, JP), additional validation may be required when sourcing from regions with differing regulatory rigor to ensure compliance.

3. How does patent protection affect API sourcing for linagliptin?
Patent restrictions can limit manufacturing to licensed or authorized suppliers. Generics companies often need licensing agreements or focus on markets where patent expiry has occurred.

4. Can APIs from different suppliers be interchangeable?
Potentially, if they meet established specifications. However, thorough analytical and bioequivalence testing is necessary to confirm interchangeability without compromising efficacy or safety.

5. What role do emerging manufacturing technologies play in API sourcing?
Innovations such as continuous flow synthesis and green chemistry techniques enhance scalability, reduce costs, and improve environmental sustainability, expanding the pool of high-quality API suppliers.

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Sources

[1] U.S. Pharmacopeia (USP), APIs Standards and Specifications.
[2] European Pharmacopoeia (EP), Monographs on Active Pharmaceutical Ingredients.
[3] GlobalData, API Manufacturing Profiles and Market Dynamics.
[4] Company Reports and Supplier Websites, including Hanmi Pharmaceutical, Lupin, Sun Pharma, and others.
[5] Regulatory Filings and Industry Publications, describing GMP compliance and manufacturing protocols.