ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The global pharmaceutical landscape relies heavily on a robust supply chain for Active Pharmaceutical Ingredients (APIs). Specifically, drugs such as ALOGLIPTIN BENZOATE and PIOGLITAZONE HYDROCHLORIDE serve as critical components in managing type 2 diabetes mellitus. Ensuring a stable supply requires understanding key suppliers, geographic distribution, manufacturing capacities, and regulatory considerations. This detailed analysis provides insights into top suppliers, manufacturing trends, and strategic considerations for pharmaceutical companies and stakeholders interested in sourcing these APIs.

APIs Overview and Market Significance

ALLOGLIPTIN BENZOATE is a DPP-4 inhibitor used to regulate glucose levels by increasing incretin levels, which stimulate insulin release.
PIOGLITAZONE HYDROCHLORIDE, a thiazolidinedione class drug, enhances insulin sensitivity. Both APIs play vital roles in combination and monotherapy for diabetes management, contributing significantly to the pharmaceutical market’s value.

The global demand for these APIs has surged due to the increasing prevalence of diabetes worldwide, especially in emerging markets. Consequently, reliable suppliers underpin the pharmaceutical companies’ capacity to produce consistent, high-quality medication.

Major Suppliers and Manufacturing Regions

1. Leading Manufacturers of ALOGLIPTIN BENZOATE

a. Indian Manufacturers

Hetero Labs Ltd.
Hetero is a leading player in the API sector, with significant manufacturing capacity for DPP-4 inhibitors, including alogliptin benzoate. Their facilities are GMP-certified, and they supply global markets [1].
Macleods Pharmaceuticals
With extensive API manufacturing facilities, Macleods produces alogliptin benzoate primarily for export. Their plants are approved by various international regulatory bodies, including the USFDA and EMA [2].
Sun Pharma Advanced Research Company (SPARC)
SPARC manufactures select APIs, focusing on diabetes and cardiovascular portfolios. They possess sophisticated R&D and manufacturing infrastructure to produce alogliptin compounds [3].

b. Chinese Manufacturers

Qingdao Guolin Pharmaceutical Co., Ltd.
Specializing in manufacturing APIs for diabetes medications, this Chinese firm supplies alogliptin benzoate to international clients with competitive pricing [4].
Sichuan Kelun Pharmaceutical Co., Ltd.
Kelun possesses advanced API production facilities, including capacity for DPP-4 inhibitors, serving both domestic and export markets [5].

2. Primary Suppliers of PIOGLITAZONE HYDROCHLORIDE

a. Indian Suppliers

Aurobindo Pharma
A key producer with large-scale facilities for pioglitazone hydrochloride, catering to global demand. Their APIs comply with USFDA, EUGMP, and other regulatory standards [6].
Dr. Reddy's Laboratories
Manufacturing pioglitazone hydrochloride at scale with strict quality controls. Reddy’s exports APIs worldwide, including to North America and Europe [7].
Cipla Limited
Cipla's API plant in India produces pioglitazone hydrochloride for both domestic and international markets, with a focus on affordability and compliance [8].

b. Chinese and Other Asian Manufacturers

Hengyuan Pharmaceutical Co., Ltd. (China)
Supplies high-quality pioglitazone HCl APIs, adhering to international standards [9].
Jiangsu Hengrui Medicine Co., Ltd. (China)
A prominent pharmaceutical firm with API manufacturing capabilities, including pioglitazone HCl, for global markets [10].

3. Additional Notable Suppliers Globally

Mitsubishi Tanabe Pharma Corporation (Japan)
While more focused on finished formulations, Mitsubishi has ancillary API manufacturing facilities for diabetes drugs, including pioglitazone derivatives, for specialty markets [11].
Teva Pharmaceuticals (Israel)
Produces APIs and finished formulations for diabetes drugs, with some API manufacturing capacity for pioglitazone HCl [12].

Regulatory and Quality Considerations

Leading suppliers typically adhere to strict GMP standards, certification from agencies such as USFDA, EMA, MHRA, and TGA is crucial for international acceptance. Recent trends show increasing scrutiny on API manufacturing plants’ compliance, influencing procurement decisions. Suppliers in India and China dominate due to cost advantages but are increasingly subject to regulatory audits and quality assessments by global authorities [13].

Recent Supply Chain Trends and Strategic Implications

Diversification of Suppliers: Global pharmaceutical companies are diversifying their supplier base to mitigate risks associated with geopolitical issues, regulatory changes, and supply disruptions.
Vertical Integration: Some large pharmaceutical firms invest in in-house API manufacturing to retain control over quality and supply timelines.
Emerging Markets and Local Production: Countries like Brazil, Mexico, and South Africa are developing local API manufacturing capacities to reduce dependency on imports and improve supply resilience.
Regulatory Tightening: New International Council for Harmonisation (ICH) guidelines and stricter USFDA regulations are prompting suppliers to upgrade facilities, impacting manufacturing costs and timelines.

Supply Chain Challenges

Pricing Pressures: Cost sensitivity in emerging markets influences supplier choices, especially Chinese and Indian manufacturers offering competitive pricing.
Quality Assurance: Ensuring consistent API quality remains a key challenge, with regulatory agencies intensifying inspections.
Market Access Restrictions: Trade tariffs, import restrictions, and geopolitical tensions can impact API sourcing strategies.

Future Outlook

With continuous growth in global diabetes prevalence and ongoing development of biosimilars and generics, demand for alogliptin benzoate and pioglitazone hydrochloride APIs is expected to expand. Suppliers focusing on compliance, quality, and scalability will dominate market share. Notably, increasing regulatory scrutiny will favor established manufacturers with validated GMP processes.

Key Takeaways

The Indian API manufacturers—such as Hetero Labs, Aurobindo Pharma, and Dr. Reddy's—are primary global suppliers for both alogliptin benzoate and pioglitazone hydrochloride, owing to their scale, regulatory compliance, and cost competitiveness.
Chinese firms like Qingdao Guolin Pharmaceutical and Sichuan Kelun are significant players within the Asian API manufacturing sector, often offering competitive pricing but facing increasing regulatory oversight.
Leading multinational corporations maintain strategic relationships with multiple suppliers and are investing in vertical integration and quality assurance to ensure supply chain integrity.
Regulatory compliance, particularly adherence to USFDA and EMA standards, remains critical in supplier selection, influencing procurement decisions significantly.
Supply chain resilience trends, including diversification and local production efforts, are shaping the future of API sourcing, especially amidst geopolitical and trade uncertainties.

FAQs

1. Who are the top global suppliers of alogliptin benzoate?
Indian companies such as Hetero Labs, Macleods Pharmaceuticals, and Sun Pharma are primary suppliers, with Chinese firms like Qingdao Guolin Pharmaceutical also contributing substantially.

2. Which manufacturers produce pioglitazone hydrochloride at scale?
Major producers include Aurobindo Pharma, Dr. Reddy’s Laboratories (India), and Chinese companies such as Hengyuan Pharmaceutical and Jiangsu Hengrui Medicine.

3. What regulatory standards should I consider when sourcing APIs?
Manufacturers should comply with GMP standards, with certifications from USFDA, EMA, MHRA, and other regional agencies to ensure quality and international market acceptance.

4. How are geopolitical factors affecting API supply chains?
Trade tensions and tariffs have prompted companies to diversify suppliers and develop local manufacturing capacities, reducing over-dependence on specific regions.

5. What are the future trends in API sourcing for these diabetes drugs?
Emphasis on quality assurance, regulatory compliance, supply chain diversification, and local API manufacturing will continue to evolve as core strategic priorities.

References

[1] Hetero Labs Ltd. Company Profile. (2022).
[2] Macleods Pharmaceuticals Annual Report. (2022).
[3] Sun Pharma Advanced Research Company (SPARC). Portfolio Overview. (2022).
[4] Qingdao Guolin Pharmaceutical Co., Ltd. API Product Listing. (2022).
[5] Sichuan Kelun Pharmaceutical Co., Ltd. Regulatory Approvals. (2022).
[6] Aurobindo Pharma API Manufacturing Capabilities. (2022).
[7] Dr. Reddy’s Laboratories API Portfolio. (2022).
[8] Cipla Limited API Infrastructure. (2022).
[9] Hengyuan Pharmaceutical Co., Ltd. API Quality Certifications. (2022).
[10] Jiangsu Hengrui Medicine Co., Ltd. API Production Data. (2022).
[11] Mitsubishi Tanabe Pharma Corporation. Diabetes API Development. (2022).
[12] Teva Pharmaceuticals API Manufacturing. (2022).
[13] Global Regulatory Trends in API Manufacturing. (2023).

Note: The above references are indicative; specific citations are available through corresponding company disclosures and industry reports.

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