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
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414	NDA	Takeda Pharmaceuticals America, Inc.	64764-335-01	4 CARTON in 1 TRAY (64764-335-01) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK	2013-01-25
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414	NDA	Takeda Pharmaceuticals America, Inc.	64764-335-60	60 TABLET, FILM COATED in 1 BOTTLE (64764-335-60)	2013-01-25
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414	NDA	Takeda Pharmaceuticals America, Inc.	64764-335-77	500 TABLET, FILM COATED in 1 BOTTLE (64764-335-77)	2013-01-25
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414	NDA	Takeda Pharmaceuticals America, Inc.	64764-335-80	180 TABLET, FILM COATED in 1 BOTTLE (64764-335-80)	2013-01-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

Alogliptin benzoate and metformin hydrochloride are widely prescribed active pharmaceutical ingredients (APIs) used in the treatment of type 2 diabetes. This report identifies key global suppliers of these APIs, examines their production capacities, regulatory compliance, and potential market shifts.

Who Are the Leading Suppliers for Alogliptin Benzoate?

The global supply chain for alogliptin benzoate is concentrated among a select group of API manufacturers, primarily located in India and China. These suppliers navigate stringent regulatory requirements and manage complex manufacturing processes to meet demand from finished dosage form manufacturers.

Sun Pharmaceutical Industries Ltd.: A major Indian pharmaceutical company with significant API manufacturing capabilities. Sun Pharma is a consistent supplier of alogliptin benzoate.
Dr. Reddy's Laboratories Ltd.: Another prominent Indian pharmaceutical firm that manufactures and supplies alogliptin benzoate. They have a global reach for API distribution.
Lupin Ltd.: An Indian multinational pharmaceutical company with a diversified API portfolio, including alogliptin benzoate.
Divi's Laboratories Ltd.: A leading Indian API manufacturer known for its large-scale production and strong regulatory adherence.
Zhejiang Huahai Pharmaceutical Co., Ltd.: A Chinese pharmaceutical company and a significant player in the global API market, including alogliptin benzoate.
Jiangsu Hengrui Medicine Co., Ltd.: A large Chinese pharmaceutical group with API manufacturing facilities that produce alogliptin benzoate.

These companies operate under Good Manufacturing Practices (GMP) and are subject to inspections by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Their ability to maintain consistent quality and supply is critical for pharmaceutical companies relying on these APIs.

What Are the Primary Suppliers for Metformin Hydrochloride?

Metformin hydrochloride is a high-volume, essential medicine for type 2 diabetes. Its supply chain is more fragmented than alogliptin benzoate, with numerous manufacturers worldwide. However, key players dominate a substantial portion of the global market.

Bristol-Myers Squibb: While primarily known for finished drug products, BMS has historical involvement in metformin hydrochloride API production and supply, often through contract manufacturing.
Shandong Xinhua Pharmaceutical Co., Ltd.: A major Chinese manufacturer that is one of the largest producers of metformin hydrochloride globally.
Metachem Manufacturing Pvt. Ltd. (India): A significant Indian supplier specializing in various APIs, including metformin hydrochloride.
Granules India Ltd.: An Indian pharmaceutical company with substantial capacity for metformin hydrochloride API production.
Jubilant Life Sciences Ltd. (now Jubilant Pharmova Ltd.): An Indian conglomerate with a strong API division that is a key supplier of metformin hydrochloride.
Anqiu Zhongtai Pharmaceutical Co., Ltd. (China): Another substantial Chinese producer of metformin hydrochloride.
Taj Pharmaceuticals Ltd. (India): A diversified Indian pharmaceutical company that supplies metformin hydrochloride API.

The large volume and critical nature of metformin hydrochloride mean that supply disruptions can have significant public health implications. Manufacturers focus on cost-effective production while adhering to strict quality and regulatory standards.

What Are the Production Capacities and Scale of Key API Manufacturers?

Accurate, real-time production capacities are proprietary and fluctuate based on market demand and strategic decisions. However, it is understood that manufacturers serving global markets, particularly for high-volume APIs like metformin hydrochloride, operate at scales of hundreds to thousands of metric tons per year.

Metformin Hydrochloride: Manufacturers like Shandong Xinhua Pharmaceutical are known to have capacities in the tens of thousands of metric tons annually for metformin hydrochloride, reflecting its status as a first-line treatment and its widespread use. The overall global capacity is estimated to be significantly higher, supporting both branded and generic drug production.
Alogliptin Benzoate: As a more specialized DPP-4 inhibitor, alogliptin benzoate production volumes are considerably lower than metformin hydrochloride. Manufacturers typically have capacities in the metric tons to tens of metric tons annually. Sun Pharma, Dr. Reddy's, and Divi's Laboratories are recognized for having substantial, albeit smaller, capacities compared to metformin producers.

The scale of operation directly impacts cost of goods. Larger capacities generally allow for greater economies of scale, leading to more competitive pricing for the APIs.

What Are the Regulatory Filings and Compliance Standards for These APIs?

Suppliers of alogliptin benzoate and metformin hydrochloride must meet rigorous international regulatory standards. Key compliance metrics include:

Drug Master Files (DMFs): Submissions to regulatory agencies (e.g., FDA in the U.S., EMA in Europe) detailing the chemistry, manufacturing, and controls of the API. A submitted and accepted DMF is crucial for finished drug product manufacturers to reference in their applications.
- U.S. FDA DMFs: Many of the identified suppliers have active DMFs for both alogliptin benzoate and metformin hydrochloride. The FDA reviews these filings as part of New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs).
- European CEPs (Certificates of Suitability to the monographs of the European Pharmacopoeia): These are critical for market access in Europe and are issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM).
GMP Certification: Facilities must be compliant with current Good Manufacturing Practices (cGMP) as defined by the FDA, EMA, and other national regulatory authorities. This includes site inspections and audits.
Impurity Profiling: Manufacturers must rigorously control and characterize impurities, especially genotoxic impurities, which have become a significant focus for regulatory bodies following recent recalls in the pharmaceutical industry. This includes identifying and quantifying N-nitrosodimethylamine (NDIMMA) and other nitrosamines.
Pharmacopoeial Compliance: APIs must meet the specifications outlined in major pharmacopoeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP).

Failure to maintain compliance can lead to warning letters, import alerts, or product recalls, severely impacting a supplier's market access and reputation.

What Are the Market Dynamics and Competitive Landscape?

The market for alogliptin benzoate and metformin hydrochloride APIs is shaped by several factors:

Generic Competition: Both APIs are off-patent in major markets, leading to intense competition among generic drug manufacturers and, consequently, pressure on API prices.
Demand for Diabetes Treatments: The global rise in type 2 diabetes prevalence continues to drive sustained demand for both metformin hydrochloride and newer antidiabetic agents like alogliptin benzoate.
Supply Chain Security and Resilience: Recent global events have highlighted the importance of diversified and resilient supply chains. Pharmaceutical companies are increasingly scrutinizing supplier locations, geopolitical stability, and contingency planning.
Quality and Regulatory Scrutiny: Increased regulatory enforcement, particularly around impurity control, means suppliers must invest in advanced analytical capabilities and process control. This can lead to higher compliance costs but also serves as a barrier to entry for less sophisticated manufacturers.
Cost Pressures: Finished dosage form manufacturers seek to minimize API costs to maintain profitability in a competitive market. This often favors suppliers with large-scale production capabilities and efficient processes.
Geographic Concentration: The concentration of manufacturing in India and China presents both opportunities and risks. While these regions offer cost advantages, geopolitical tensions, trade policies, and localized disruptions can impact global supply.

For alogliptin benzoate, competition is less intense than for metformin hydrochloride due to its later patent expiry and more complex synthesis. However, the pressure to provide cost-effective and high-quality APIs remains.

What Are the Potential Market Trends and Risks for API Suppliers?

Several trends and risks will shape the future market for these APIs:

Emerging Markets Growth: The increasing incidence of type 2 diabetes in emerging economies will drive demand for both established and newer antidiabetic medications, creating opportunities for API suppliers to expand their reach.
Technological Advancements: Innovations in continuous manufacturing and process analytical technology (PAT) could enhance efficiency, reduce waste, and improve quality control for API production.
Regulatory Harmonization vs. Divergence: While efforts towards global regulatory harmonization continue, differing national requirements, especially concerning impurity standards, can create compliance complexities for suppliers.
Geopolitical Instability and Trade Wars: Tariffs, trade disputes, and political instability in key manufacturing regions can disrupt supply chains, increase costs, and necessitate diversification strategies for buyers.
Sustainability and Environmental Regulations: Increasing focus on environmental impact may lead to stricter regulations on chemical manufacturing processes, requiring significant investment in greener technologies.
Consolidation in the API Sector: Mergers and acquisitions within the API manufacturing sector could lead to further consolidation, potentially impacting pricing and supplier availability.

API suppliers must proactively manage these trends by investing in R&D, ensuring robust compliance, diversifying their geographic footprint where possible, and building strong relationships with their customers.

Key Takeaways

Alogliptin benzoate suppliers are primarily located in India and China, with key players including Sun Pharma, Dr. Reddy's, and Zhejiang Huahai.
Metformin hydrochloride has a more diffuse supply base, with significant production from Chinese manufacturers like Shandong Xinhua Pharmaceutical, alongside Indian companies such as Granules India and Jubilant Pharmova.
Production capacities for metformin hydrochloride are in the thousands of metric tons annually, while alogliptin benzoate capacities are in the tens of metric tons annually.
Regulatory compliance, including FDA DMFs, European CEPs, and cGMP adherence, is paramount for market access.
The market is characterized by intense generic competition for metformin hydrochloride and significant price pressure driven by volume.
Future trends include growth in emerging markets, technological advancements in manufacturing, and the ongoing impact of regulatory scrutiny and geopolitical factors.

Frequently Asked Questions

What is the typical lead time for API orders of alogliptin benzoate and metformin hydrochloride from major suppliers? Lead times can vary significantly based on supplier stock levels, production schedules, and order volume. For established, high-volume APIs like metformin hydrochloride from large manufacturers, lead times might range from 4 to 12 weeks. For specialized APIs like alogliptin benzoate, especially for smaller batches or custom requirements, lead times could extend to 12 to 24 weeks or longer. Expedited orders may be possible for premium pricing.
Are there any API suppliers facing recent regulatory challenges regarding nitrosamine impurities for these specific drugs? While specific nitrosamine impurity issues have affected various APIs across the industry, publicly disclosed regulatory actions directly targeting alogliptin benzoate or metformin hydrochloride for nitrosamine contamination by major listed suppliers are not currently prominent in recent FDA or EMA enforcement reports. However, suppliers of all APIs are under increased scrutiny to develop and validate robust analytical methods for nitrosamine detection. Continuous monitoring and proactive impurity control are essential for all manufacturers.
What is the current typical price range for alogliptin benzoate and metformin hydrochloride APIs per kilogram? API pricing is highly dynamic and influenced by volume, purity specifications, regulatory filings, and market competition. Generally, metformin hydrochloride, due to its high volume and mature generic status, is priced in the range of $5 to $20 per kilogram. Alogliptin benzoate, being a more complex molecule with a later patent expiry, commands a higher price, typically ranging from $100 to $500 per kilogram, depending on the supplier, quantity, and specific quality standards. These are indicative ranges and actual negotiated prices can differ.
Do any of the listed suppliers have FDA Warning Letters specifically related to their alogliptin benzoate or metformin hydrochloride manufacturing processes? As of the most recent publicly available FDA enforcement data, there are no widespread, current FDA Warning Letters specifically naming major suppliers for issues directly tied to the manufacturing of alogliptin benzoate or metformin hydrochloride that have resulted in market exclusion for these specific APIs. However, regulatory actions can evolve. It is critical for buyers to conduct due diligence on a supplier's current compliance status before placing orders.
What impact does the increasing demand for combination drug products (e.g., alogliptin + metformin) have on API suppliers? The demand for fixed-dose combination (FDC) products increases the demand for both individual APIs. Suppliers who can provide both alogliptin benzoate and metformin hydrochloride APIs may benefit from supplying integrated solutions to FDC manufacturers. It also places a premium on reliable, consistent supply of both components to ensure uninterrupted production of the combination therapy. Manufacturers of FDCs often prefer suppliers with strong regulatory track records and the capacity to meet large, sustained orders for both APIs.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drugs@FDA. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/ [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Home page. Retrieved from https://www.edqm.eu/en [3] Various Company Websites and Public Filings (Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories Ltd., Lupin Ltd., Divi's Laboratories Ltd., Zhejiang Huahai Pharmaceutical Co., Ltd., Jiangsu Hengrui Medicine Co., Ltd., Shandong Xinhua Pharmaceutical Co., Ltd., Metachem Manufacturing Pvt. Ltd., Granules India Ltd., Jubilant Pharmova Ltd., Anqiu Zhongtai Pharmaceutical Co., Ltd., Taj Pharmaceuticals Ltd., Bristol-Myers Squibb). Accessed via financial news databases and corporate reporting portals. [4] Global Pharmaceutical Market Research Reports. (Various Publishers). Data on API market size, supplier capacities, and pricing trends.

Suppliers and packagers for generic pharmaceutical drug: ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE