alogliptin benzoate; pioglitazone hydrochloride: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426	NDA AUTHORIZED GENERIC	Padagis Israel Pharmaceuticals Ltd	45802-260-65	30 TABLET, FILM COATED in 1 BOTTLE (45802-260-65)	2016-04-08
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426	NDA AUTHORIZED GENERIC	Padagis Israel Pharmaceuticals Ltd	45802-351-65	30 TABLET, FILM COATED in 1 BOTTLE (45802-351-65)	2016-04-08
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426	NDA AUTHORIZED GENERIC	Padagis Israel Pharmaceuticals Ltd	45802-402-65	30 TABLET, FILM COATED in 1 BOTTLE (45802-402-65)	2016-04-08
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426	NDA AUTHORIZED GENERIC	Padagis Israel Pharmaceuticals Ltd	45802-499-65	30 TABLET, FILM COATED in 1 BOTTLE (45802-499-65)	2016-04-08
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426	NDA	Takeda Pharmaceuticals America, Inc.	64764-123-03	30 TABLET, FILM COATED in 1 BOTTLE (64764-123-03)	2013-01-25
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426	NDA	Takeda Pharmaceuticals America, Inc.	64764-123-04	90 TABLET, FILM COATED in 1 BOTTLE (64764-123-04)	2013-01-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report analyzes key suppliers for the pharmaceutical active pharmaceutical ingredients (APIs) alogliptin benzoate and pioglitazone hydrochloride. It identifies major manufacturers, their production capabilities, geographic presence, and relevant patent and regulatory landscapes. The analysis targets business professionals in R&D and investment roles within the pharmaceutical industry.

What are the primary therapeutic uses of alogliptin benzoate and pioglitazone hydrochloride?

Alogliptin benzoate is a dipeptidyl peptidase-4 (DPP-4) inhibitor used to improve glycemic control in adults with type 2 diabetes mellitus. It works by increasing the levels of incretin hormones, which stimulate insulin secretion and decrease glucagon production. Pioglitazone hydrochloride is a thiazolidinedione (TZD) antidiabetic drug that enhances insulin sensitivity in peripheral tissues and the liver. It is also used to manage type 2 diabetes mellitus.

Who are the key manufacturers and suppliers of alogliptin benzoate API?

Several manufacturers produce alogliptin benzoate API. The market is characterized by both originator-produced API and generic API suppliers.

Key Alogliptin Benzoate API Manufacturers:

Takeda Pharmaceutical Company: As the originator of alogliptin (Nesina/Vipidia), Takeda is a primary source of API. Their production is often integrated within their manufacturing operations.
Divi's Laboratories: This Indian API manufacturer is a significant player in the global pharmaceutical API market. Divi's has established capabilities for complex API synthesis, including DPP-4 inhibitors.
Laurus Labs: Another prominent Indian pharmaceutical company, Laurus Labs, is known for its API manufacturing expertise. They supply a range of APIs to global markets, and alogliptin benzoate is within their portfolio.
Dr. Reddy's Laboratories: A global pharmaceutical company headquartered in India, Dr. Reddy's offers a broad spectrum of APIs. Their manufacturing infrastructure supports the production of various diabetes medications, including alogliptin benzoate.
Sun Pharmaceutical Industries: Sun Pharma is one of the largest generic pharmaceutical companies globally. They maintain extensive API manufacturing facilities and are a significant supplier to the global market for multiple therapeutic areas.
Aurobindo Pharma: Aurobindo Pharma is a vertically integrated pharmaceutical company with strong API manufacturing capabilities. They produce APIs for both their own finished dosage forms and for external sale.
Cipla: Cipla is an Indian multinational pharmaceutical company that produces a wide range of APIs. They are known for their cost-effective manufacturing and global reach.

Production Capabilities and Geographic Presence:

A significant portion of alogliptin benzoate API manufacturing is concentrated in India due to cost advantages, established regulatory compliance, and skilled labor. Manufacturers in this region typically operate large-scale facilities compliant with Good Manufacturing Practices (GMP) standards set by major regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Some manufacturers also have production sites in China, though regulatory oversight and quality consistency can vary.

What is the patent landscape for alogliptin benzoate?

The patent landscape for alogliptin benzoate is largely defined by the originator's patents, which cover the compound itself, its therapeutic uses, and various manufacturing processes. As patents expire, opportunities for generic manufacturers increase.

Key Patent Considerations for Alogliptin Benzoate:

Composition of Matter Patents: The primary patent protecting the alogliptin molecule itself is crucial. The expiration of these patents opens the door for generic competition. Takeda's foundational patents for alogliptin have been subject to expiration in various markets.
Process Patents: Patents covering specific methods of synthesizing alogliptin benzoate can also impact generic production. Manufacturers must develop non-infringing synthesis routes.
Formulation Patents: Patents related to specific drug formulations (e.g., extended-release versions) can extend market exclusivity even after the compound patent expires.
Market Exclusivity: Regulatory bodies grant periods of market exclusivity for new drugs, independent of patent protection, which can delay generic entry.

Patent Expiration Trends:

The initial composition of matter patents for alogliptin have expired or are nearing expiration in major markets like the United States and Europe, leading to increased generic activity. Companies looking to enter this market must conduct thorough freedom-to-operate analyses to navigate existing patents for manufacturing processes and formulations.

Who are the key manufacturers and suppliers of pioglitazone hydrochloride API?

Pioglitazone hydrochloride is a well-established generic medication, resulting in a more mature and competitive API supply market.

Key Pioglitazone Hydrochloride API Manufacturers:

Lilly (Eli Lilly and Company): As the originator of pioglitazone (Actos), Lilly was the initial producer. While originator production may still occur, the market is now dominated by generic API suppliers.
Divi's Laboratories: A significant supplier of pioglitazone hydrochloride, leveraging its large-scale API manufacturing capabilities and global distribution network.
Dr. Reddy's Laboratories: This company is a substantial producer and supplier of pioglitazone hydrochloride API, serving both domestic and international markets.
Sun Pharmaceutical Industries: Sun Pharma's extensive API manufacturing infrastructure includes pioglitazone hydrochloride, making them a key player in the generic market.
Aurobindo Pharma: Aurobindo Pharma manufactures pioglitazone hydrochloride API, contributing to the global supply chain for this essential diabetes medication.
Jubilant Pharmova: Jubilant is a global integrated pharmaceutical company with robust API manufacturing operations, including pioglitazone hydrochloride.
Teva Pharmaceutical Industries: While primarily known for finished dosage forms, Teva also has significant API manufacturing operations and is a potential supplier.
Zhejiang NHU Co., Ltd.: A prominent Chinese manufacturer of APIs, Zhejiang NHU is a notable supplier in the global pioglitazone hydrochloride market.

Production Capabilities and Geographic Presence:

The manufacturing of pioglitazone hydrochloride API is global, with a strong concentration in India and China. Indian manufacturers are recognized for their adherence to international regulatory standards and competitive pricing. Chinese manufacturers also play a crucial role in the supply chain, offering high-volume production. Companies in these regions operate under stringent GMP guidelines to meet the requirements of regulated markets.

What is the patent landscape for pioglitazone hydrochloride?

Pioglitazone hydrochloride is a mature drug, and its primary patents have long expired, making it largely a generic market.

Key Patent Considerations for Pioglitazone Hydrochloride:

Composition of Matter Patents: The original patents for pioglitazone have expired, allowing for widespread generic production.
Process Patents: While the core compound is off-patent, specific improved synthesis processes may still be protected. Manufacturers must ensure their production methods do not infringe on these.
Polymorphism and Salt Forms: Patents can exist for specific crystalline forms (polymorphs) or salt forms of pioglitazone that offer improved stability or bioavailability.
Combination Therapies: Patents may cover formulations that combine pioglitazone with other antidiabetic agents.

Patent Expiration Trends:

Pioglitazone hydrochloride has been available as a generic for many years. The focus for new entrants or established players is on cost-effective manufacturing, supply chain reliability, and compliance with evolving regulatory requirements rather than novel patentable aspects of the molecule itself.

What regulatory considerations are critical for these APIs?

The manufacturing and supply of alogliptin benzoate and pioglitazone hydrochloride APIs are subject to rigorous regulatory oversight by health authorities worldwide.

Key Regulatory Requirements:

Good Manufacturing Practices (GMP): Manufacturers must adhere to cGMP guidelines as established by regulatory bodies like the FDA (21 CFR Parts 210 & 211), EMA, and others. This includes stringent controls over facilities, equipment, personnel, manufacturing processes, quality control, and documentation.
Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. These confidential documents provide detailed information about the manufacturing process, quality control, and facilities. Health authorities review DMFs when evaluating drug product applications.
Inspections: Manufacturing sites are subject to periodic inspections by regulatory agencies to verify GMP compliance. Successful inspection outcomes are critical for market access.
Impurity Profiling: Strict limits are placed on impurities, including residual solvents, heavy metals, and process-related impurities. Manufacturers must develop robust analytical methods to detect and quantify these.
Stability Testing: APIs must undergo comprehensive stability testing under various conditions to establish retest periods and storage recommendations.
ANDA/MAA Filings: Finished dosage form manufacturers rely on the quality and regulatory compliance of the API supplied by their partners for their Abbreviated New Drug Applications (ANDAs) in the U.S. or Marketing Authorization Applications (MAAs) in Europe.

Geographic Regulatory Approvals:

API suppliers aim for approvals in major markets, including the United States, European Union, Japan, Canada, and Australia. Compliance with the specific requirements of each regulatory body is essential. For example, the FDA requires U.S. Agent representation and adherence to specific reporting requirements.

What are the supply chain dynamics and potential risks?

The supply chain for both alogliptin benzoate and pioglitazone hydrochloride APIs is global, presenting both opportunities and challenges.

Supply Chain Dynamics:

Geographic Concentration: A significant portion of API manufacturing for both compounds is based in India and China. This concentration offers economies of scale but also creates potential vulnerabilities.
Vertical Integration: Some large pharmaceutical companies are vertically integrated, producing their own APIs, while others rely on contract manufacturing organizations (CMOs) or independent API suppliers.
Competition: The pioglitazone hydrochloride market is highly competitive due to its generic status, driving price pressures. The alogliptin benzoate market is evolving as more generic players enter following patent expirations.
Quality Assurance: Ensuring consistent API quality from different suppliers is paramount. Robust vendor qualification programs and ongoing quality audits are critical.

Potential Risks:

Geopolitical Instability: Disruptions in major manufacturing regions due to political events, trade disputes, or natural disasters can impact supply.
Regulatory Changes: Evolving regulatory requirements, such as stricter impurity limits or new GMP standards, can necessitate process modifications and investment.
Quality Failures: API recalls or quality issues can lead to drug shortages, reputational damage, and significant financial losses.
Supply Chain Disruptions: Events like pandemics (e.g., COVID-19) can highlight the fragility of global supply chains, leading to raw material shortages and transportation delays.
Raw Material Sourcing: Dependence on specific raw material suppliers, especially those in concentrated regions, can create single points of failure.

How can companies assess API suppliers for these drugs?

A systematic approach to supplier assessment is crucial for ensuring reliable and compliant API sourcing.

Supplier Assessment Criteria:

Regulatory Compliance:
- Track record of successful FDA, EMA, and other major regulatory body inspections.
- Availability of up-to-date DMFs.
- Adherence to ICH guidelines.
Quality Management System:
- Robust quality control and quality assurance procedures.
- Documented batch release testing and specifications.
- History of quality events and corrective actions.
Manufacturing Capabilities:
- Production scale and capacity to meet demand.
- Process validation and control.
- Technological expertise in complex synthesis.
Financial Stability and Business Continuity:
- Financial health of the supplier.
- Business continuity plans to address potential disruptions.
- Supply chain transparency for key raw materials.
Cost and Lead Times:
- Competitive pricing without compromising quality.
- Reliable lead times for order fulfillment.
Intellectual Property (IP) Compliance:
- Demonstrated freedom to operate for their manufacturing process.
- Understanding of patent landscape.

Companies should conduct thorough due diligence, including on-site audits, review of quality agreements, and continuous performance monitoring. For alogliptin benzoate, particular attention should be paid to patent expiry timelines and the availability of non-infringing processes. For pioglitazone hydrochloride, the focus is on cost-efficiency and consistent, high-quality production.

Key Takeaways

Alogliptin Benzoate Market: Driven by originator Takeda, with increasing generic participation following patent expirations. Key generic API suppliers are predominantly based in India.
Pioglitazone Hydrochloride Market: A mature, highly competitive generic market with a broad base of global suppliers, primarily from India and China.
Regulatory Landscape: GMP compliance, DMF submissions, and successful regulatory inspections are non-negotiable for all suppliers seeking market access.
Supply Chain Risks: Geopolitical factors, quality failures, and potential disruptions in concentrated manufacturing regions (India, China) represent significant supply chain risks.
Supplier Due Diligence: A comprehensive assessment focusing on regulatory compliance, quality systems, manufacturing capacity, and financial stability is critical for API sourcing.

Frequently Asked Questions

What is the typical purity requirement for alogliptin benzoate API intended for regulated markets? API intended for regulated markets typically requires a purity of 99.0% or higher, with strict limits on specified and unspecified impurities, residual solvents, and heavy metals, as per pharmacopoeial standards (e.g., USP, EP) and ICH guidelines.
Are there any specific challenges associated with the synthesis of pioglitazone hydrochloride that manufacturers must address? Key synthesis challenges for pioglitazone hydrochloride include controlling specific isomeric impurities and ensuring consistent crystalline form. Manufacturers must also manage process-related impurities and residual solvents to meet stringent pharmacopoeial limits.
What impact do patent expiries in Europe have on API suppliers for alogliptin benzoate? Patent expiries in Europe enable generic manufacturers to produce and supply alogliptin benzoate API without infringing originator patents. This typically leads to increased competition among API suppliers and potentially lower API pricing.
How does the regulatory status of a Chinese API manufacturer differ from that of an Indian manufacturer for the U.S. market? Both Indian and Chinese API manufacturers must meet FDA cGMP standards and have their Drug Master Files (DMFs) reviewed. The FDA conducts inspections in both countries. While there have been historical concerns regarding quality control in some Chinese facilities, many Chinese API manufacturers now operate under stringent quality systems and are successfully inspected by the FDA.
Can a company source both alogliptin benzoate and pioglitazone hydrochloride from a single API supplier? Yes, it is possible to source both APIs from a single supplier if that supplier has the manufacturing capabilities, regulatory approvals, and quality systems in place to produce both compounds to the required pharmacopoeial and regulatory standards. This can offer supply chain efficiencies.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidance-industry

[2] European Medicines Agency. (n.d.). Information for applicants and marketing authorisation holders. Retrieved from https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation

[3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/

[4] United States Pharmacopeia. (n.d.). USP Standards. Retrieved from https://www.usp.org/

[5] European Pharmacopoeia. (n.d.). About the European Pharmacopoeia. Retrieved from https://www.edqm.eu/en/european-pharmacopoeia

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