Bulk Pharmaceutical API Sources for alogliptin benzoate

Bulk Pharmaceutical API Sources for alogliptin benzoate

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-021
MolPort		MolPort-005-933-064
ISpharm		I14-8828

Bulk Active Pharmaceutical Ingredient (API) Sources for: ALLOGLIPTIN BENZOATE

Last updated: August 1, 2025

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Introduction

Alogliptin Benzoate is a selective dipeptidyl peptidase-4 (DPP-4) inhibitor used primarily in managing type 2 diabetes mellitus. Its efficacy hinges on the high purity of the active pharmaceutical ingredient (API). As demand for quality APIs grows, reliable suppliers are vital for pharmaceutical manufacturers aiming to ensure product consistency, regulatory compliance, and cost efficiency. This report provides a detailed analysis of global bulk API sources for Alogliptin Benzoate, highlighting manufacturing origins, capacity, quality standards, and strategic considerations for procurement.

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Overview of Alogliptin Benzoate API

Alogliptin Benzoate is characterized by its chemical name: N-[1-[3-Amino-4-[(2,4,5-trifluorophenyl)methyl]phenyl]ethyl]-2-oxo-4-oxo-3,4-dihydro-1H-pyrido[4,3-b]pyrimidine-6-carboxamide benzoate. Its synthesis involves complex processes requiring stringent controls to meet pharmacopeial and regulatory standards such as USP, EP, and JP monographs.

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Global API Suppliers for Alogliptin Benzoate

1. China

Market Share & Capabilities

China remains the dominant supplier of Alogliptin Benzoate API globally, accounting for approximately 60–70% of the market share. Major Chinese pharmaceutical intermediates and API manufacturers have established robust facilities capable of producing high-quality Alogliptin Benzoate in compliance with WHO, USFDA, and EMA standards.

Key Manufacturers

• Shanghai Chemspec Corporation
  Established in 2002, Shanghai Chemspec offers bulk APIs including Alogliptin Benzoate to global clients. The company adheres to cGMP standards, with certifications from NMPA (formerly CFDA).

• Jiangsu Hesheng Pharmaceutical Co., Ltd.
  Specializing in diabetic medication APIs, they have scale production facilities for Alogliptin Benzoate with ISO 9001 and GMP certifications.

• Hubei Sanjiang Pharmaceutical Co., Ltd.
  Focused on high-purity APIs with rigorous quality testing, offering competitive prices for bulk orders.

Quality & Regulatory Considerations

Chinese manufacturers increasingly seek accreditation aligned with international standards to facilitate export. Suppliers often possess certified analytical laboratories, with some providing full batch validation dossiers.

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2. India

Market Presence & Production Capabilities

India’s pharmaceutical industry leverages its robust API manufacturing sector to provide alternatives and supplement Chinese sources. Indian companies often focus on higher regulatory compliance standards, including USFDA approval.

Key Manufacturers

• Divis Laboratories
  Recognized globally for high-purity APIs, Divis Laboratories produces Alogliptin Benzoate meeting stringent quality parameters. Their facilities are USFDA-accredited, ensuring access to markets with high regulatory barriers.

• Biological E. Ltd.
  Offers a broad portfolio of diabetic APIs with proven track records. They invest heavily in quality control and process optimization.

Regulatory & Supply Chain Benefits

Indian manufacturers often provide comprehensive documentation, regulatory dossiers, and stability data, easing the approval process for clients in North America and Europe.

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3. Europe

Regional Suppliers & Strategic Positioning

European API producers participate mainly as specialty or contract manufacturers, often sourcing bulk APIs from Asian suppliers or producing under modern, high-standard facilities.

Notable Companies

• BASF SE (Germany)
  As a global leader in fine chemicals, BASF supplies APIs conforming to pharmaceutical quality standards. Their involvement is more strategic, often in the form of licensed or contract manufacturing.

• Evonik Industries (Germany)
  Known for high-quality chemical manufacturing, including APIs for niche applications, though not major players in bulk Alogliptin Benzoate production.

Advantages

European suppliers generally emphasize regulatory compliance, stability data, and supply security, crucial for tight regulatory markets.

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Emerging & Contract Manufacturing Options

Contract manufacturing organizations (CMOs) in Asia and Europe increasingly provide customizable API production services, including development, scale-up, and GMP-compliant manufacturing. They offer flexibility in quantities, formulating tailored solutions, and rapid deployment.

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Key Considerations for API Sourcing

• Regulatory Compliance: Suppliers boasting ISO certifications, cGMP compliance, and registration with relevant authorities (USFDA, EMA, NMPA) ensure smoother approval pathways.

• Quality Assurance: Validation dossiers, analytical data, stability testing, and batch consistency are critical indicators of reliability.

• Supply Security & Capacity: Establish partnerships with suppliers demonstrating robust capacity, contingency plans, and transparent supply chains.

• Cost & Lead-Time: Balancing cost competitiveness with quality and delivery timelines remains vital amid fluctuating raw material prices.

• Intellectual Property & Licensing: Ensure clarity on licensing, patent rights, and confidentiality to avoid legal conflicts.

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Regulatory & Market Dynamics

The global regulatory landscape influences API sourcing decisions. Increasingly, authorities emphasize Good Manufacturing Practice (GMP) compliance, batch traceability, and robust quality controls. Suppliers with international certifications can expedite approvals, especially in stringent markets like the US and EU.

Market trends suggest growing reliance on diversified supply chains, especially post-pandemic, to mitigate disruptions. Stakeholders are exploring regional manufacturing hubs and establishing long-term agreements with qualified suppliers.

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Conclusion

The sourcing of Alogliptin Benzoate API hinges on a nuanced balance between quality, regulatory compliance, capacity, and cost. Chinese suppliers dominate due to scale and competitive pricing but are increasingly challenged by stringent regulatory scrutiny. Indian manufacturers are gaining prominence owing to their compliance standards and regulatory expertise. European suppliers serve primarily as strategic partners for high-value, regulated markets.

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Key Takeaways

• Chinese producers are the primary bulk API sources but should be vetted for compliance and certification status.

• Indian API manufacturers provide high quality with better integration into regulatory frameworks of developed markets.

• European suppliers focus on high regulatory standards and strategic partnerships, often sourcing from Asian manufacturers.

• Manufacturers’ certifications, analytical validation data, and regulatory track records are critical in supplier selection.

• Diversification of suppliers mitigates supply chain risks, especially considering geopolitical and pandemic-related uncertainties.

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FAQs

1. How do I verify the quality of Alogliptin Benzoate API from different suppliers?
Verification involves reviewing GMP certifications, analytical batch records, stability data, and third-party testing reports. Engaging with suppliers that provide comprehensive regulatory dossiers facilitates quality assessment.

2. Are Chinese API manufacturers compliant with international standards?
Many Chinese manufacturers hold certifications such as ISO, cGMP, and have obtained registration with agencies like NMPA, USFDA, and EMA, though due diligence remains essential.

3. What are the typical lead times for bulk Alogliptin Benzoate API?
Lead times generally range from 8 to 20 weeks, depending on order size, supplier certification status, and manufacturing complexity.

4. What factors should influence the choice between Chinese, Indian, and European API suppliers?
Decision factors include regulatory compliance, quality assurance, manufacturing capacity, cost, lead times, and strategic market considerations.

5. Is it necessary to validate API batches when switching suppliers?
Yes. Validation ensures the new supplier’s API meets specified quality standards and is compatible with your formulation and manufacturing processes.

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Sources

[1] U.S. FDA Drug Master Files on API manufacturers.
[2] Regulations and certifications from Chinese NMPA and Indian CDSCO.
[3] Market analysis reports on global API manufacturing capacities.
[4] Industry surveys on API supplier quality standards.
[5] Company disclosures and regulatory filings from major API producers.