alogliptin benzoate; metformin hydrochloride: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414	NDA AUTHORIZED GENERIC	Padagis Israel Pharmaceuticals Ltd	45802-169-72	60 TABLET, FILM COATED in 1 BOTTLE (45802-169-72)	2016-04-08
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414	NDA AUTHORIZED GENERIC	Padagis Israel Pharmaceuticals Ltd	45802-211-72	60 TABLET, FILM COATED in 1 BOTTLE (45802-211-72)	2016-04-08
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-5993-0	90 TABLET, FILM COATED in 1 BOTTLE (50090-5993-0)	2016-04-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

In the pharmaceutical industry, sourcing high-quality active pharmaceutical ingredients (APIs) like alogliptin benzoate and metformin hydrochloride requires navigating a complex landscape of global suppliers. These APIs serve as crucial components in medications for managing type 2 diabetes and related metabolic conditions. Reliable suppliers ensure product quality, regulatory compliance, and consistent supply chains, directly impacting drug efficacy and market stability.

This article provides a comprehensive overview of the leading suppliers for alogliptin benzoate and metformin hydrochloride, analyzing their manufacturing capabilities, certifications, geographic distribution, and market presence. The goal is to enable pharmaceutical companies, formulators, and procurement professionals to make well-informed sourcing decisions.

Alogliptin Benzoate: Market Overview and Supplier Landscape

Alogliptin Benzoate is a dipeptidyl peptidase-4 (DPP-4) inhibitor used primarily for managing type 2 diabetes mellitus. It is marketed globally under various brand names and as an active pharmaceutical ingredient (API) supplied to pharmaceutical manufacturers.

Key Suppliers of Alogliptin Benzoate

Suzhou Gufeng Pharmaceutical Co., Ltd. (China)
- Capabilities: Gufeng is a prominent Chinese API manufacturer specializing in cardiovascular and antidiabetic APIs, including alogliptin benzoate.
- Certifications: GMP-compliant facilities, ISO 9001:2015 certification, and adherence to the China Food and Drug Administration (CFDA) standards.
- Strengths: High-volume production capacity, competitive pricing, and a significant exporter to Asian, European, and North American markets.
Hubei Zhipu Pharmaceutical Co., Ltd. (China)
- Capabilities: Produces a range of APIs, including DPP-4 inhibitors, with a focus on quality control and regulatory compliance.
- Certifications: GMP, ISO 9001, and exclusive regional approval for certain APIs.
- Strengths: Established R&D, robust quality assurance protocols, and scalable manufacturing.
Eka Chemicals (India)
- Capabilities: A global supplier with expertise in pharmaceutical intermediates and APIs, including alogliptin benzoate.
- Certifications: GMP, ISO, and EU-GMP standards.
- Strengths: Global reach, strong logistics network, and diversified product portfolio.
CordenPharma (Germany)
- Capabilities: Specializes in complex API manufacturing, offering custom synthesis and high-purity APIs.
- Certifications: EU-GMP, FDA approval, and extensive quality management systems.
- Strengths: High purity standards, advanced process development, and compliance with international regulatory norms.
Aurobindo Pharma (India)
- Capabilities: Besides finished formulations, Aurobindo manufactures a broad spectrum of APIs including antidiabetics.
- Certifications: US FDA, EU-GMP, and ISO standards.
- Strengths: Large-scale manufacturing, integrated supply chain, and global distribution.

Metformin Hydrochloride: Market and Supplier Analysis

Metformin hydrochloride is a widely used first-line oral medication for type 2 diabetes, recognized for its efficacy, safety, and affordability. Its high global demand has led to a robust supplier ecosystem, primarily based in India, China, and Europe.

Leading Suppliers of Metformin Hydrochloride

Sun Pharmaceutical Industries Ltd. (India)
- Capabilities: One of the world's largest producers of generic pharmaceuticals, including metformin hydrochloride.
- Certifications: US FDA, EU-GMP, ISO 9001.
- Strengths: Extensive manufacturing capacity, reliable supply, and regulatory approvals in multiple markets.
Lupin Limited (India)
- Capabilities: Manufactures APIs across several therapeutic classes, with a significant portfolio in antidiabetics.
- Certifications: US FDA, EMA, MHRA, ISO.
- Strengths: Strong R&D pipeline, modern manufacturing facilities, and proven export channels.
Macleods Pharmaceuticals (India)
- Capabilities: Produces high-quality metformin hydrochloride suitable for various formulations.
- Certifications: US FDA, UK MHRA, WHO GMP.
- Strengths: Cost competitiveness, reliable quality, and global regulatory access.
Hubei Huarong Pharmaceutical (China)
- Capabilities: Supplies bulk quantities of metformin with a focus on Asian and emerging markets.
- Certifications: GMP, ISO 9001.
- Strengths: Competitive pricing, large manufacturing volumes, and regional presence.
Teva Pharmaceutical Industries Ltd. (Israel)
- Capabilities: A major player in generic APIs, including metformin hydrochloride, serving worldwide markets.
- Certifications: US FDA, EMA, ISO.
- Strengths: Robust production infrastructure, diversified product portfolio, and global distribution.

Critical Considerations in API Supplier Selection

Regulatory Compliance: Suppliers must adhere to GMP standards per regional authorities (FDA, EMA, CFDA). Certification validation ensures product quality and regulatory acceptance.

Manufacturing Capacity and Reliability: Large-volume capacity and proven track records with consistent delivery are crucial, especially for high-demand APIs like metformin.

Quality Assurance and Testing: Suppliers should conduct rigorous in-house testing, including HPLC, residual solvents, and endotoxin testing to ensure APIs meet pharmacopoeial standards (USP, EP, JP).

Pricing and Lead Times: Competitive pricing must be balanced with quality and certification to avoid supply disruptions and regulatory setbacks.

Geographic Diversification: Sourcing from multiple regions mitigates risks related to geopolitical tensions, natural disasters, or localized regulatory changes.

Market Trends and Future Outlook

The APIs for alogliptin benzoate and metformin hydrochloride are primarily sourced from Asia, given the region's cost advantages and mature pharmaceutical manufacturing hubs. However, increasing regulatory scrutiny and quality demands are prompting global companies to diversify suppliers and invest in supplier qualification programs.

Emerging markets like Southeast Asia and Africa are witnessing increased APIs manufacturing capacity, driven by local demand and incentives for API manufacturing. Additionally, the growing demand for combination therapies and generic versions amplifies the need for reliable, high-quality suppliers.

Advancements in sustainable manufacturing, cleaner processes, and stricter regulatory standards will further shape the supplier landscape, demanding transparency and continuous quality improvement.

Key Takeaways

Diverse supplier base: Chinese and Indian manufacturers dominate the API supply for alogliptin benzoate and metformin hydrochloride, supported by European and Israeli high-quality producers.
Regulatory compliance is essential: GMP certification and adherence to international standards are non-negotiable for reliable supply and market approval.
Capacity and reliability matter: Large-scale producers with proven track records reduce risks of shortages and quality issues.
Price versus quality: Cost advantages must be balanced against the demands for regulatory compliance, purity, and supply consistency.
Future growth: Increasing regional manufacturing capabilities and focus on quality standards are expected to strengthen the supply chain for these APIs.

FAQs

1. Where are the primary manufacturing hubs for alogliptin benzoate?
Chinese companies dominate production, with major players like Suzhou Gufeng Pharmaceutical and Hubei Zhipu Pharmaceutical leading. European manufacturers like CordenPharma also produce high-purity variants.

2. What certifications should suppliers of metformin hydrochloride hold?
Suppliers should possess GMP certification from authorities like the US FDA, EMA, or equivalent regional regulators, along with ISO 9001 accreditation.

3. How can companies verify the quality of API suppliers?
Verification can involve audit reports, certification validation, independent testing of samples, regulatory approval history, and supplier qualification audits.

4. Are there sustainable or eco-friendly manufacturing options available for these APIs?
Yes. Several manufacturers are adopting greener processes, reducing solvent use, and implementing environmental management systems to meet sustainability standards.

5. What emerging markets could influence the API supply chain?
Southeast Asian countries like Vietnam and Indonesia are developing large API manufacturing capacities, driven by government incentives and increasing domestic demand.

References

[1] "Global API Market Overview," IQVIA Institute, 2022.
[2] "List of GMP-Certified API Manufacturers," WHO, 2023.
[3] "Regulatory Standards for API Manufacturing," U.S. FDA, 2023.
[4] "China's API Industry Overview," CN Drug, 2022.
[5] "Indian Pharmaceutical Industry & API Manufacturing," Indian Pharmasources, 2022.

This article is intended to guide pharmaceutical procurement strategies by highlighting key suppliers and market dynamics for alogliptin benzoate and metformin hydrochloride. Due diligence and ongoing supplier qualification are essential in maintaining a resilient, compliant supply chain.

Suppliers and packagers for generic pharmaceutical drug: alogliptin benzoate; metformin hydrochloride