Last updated: August 3, 2025
Introduction
ACTOPLUS MET is a combination pharmaceutical product primarily used for managing type 2 diabetes mellitus. It comprises two active ingredients: Alogliptin and Metformin. Alogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, enhances incretin hormone activity, improving insulin secretion. Metformin, a widely used biguanide, reduces hepatic glucose production and improves insulin sensitivity. The combination offers effective glycemic control with a favorable safety profile.
The global market for ACTOPLUS MET is dynamic, driven by rising diabetes prevalence. Securing reliable suppliers ensures product quality, regulatory compliance, and competitive pricing. This paper explores the key suppliers manufacturing ACTOPLUS MET or its active ingredients, highlighting regulatory considerations, manufacturing capacities, and market distribution.
Manufacturers of ACTOPLUS MET
1. Daiichi Sankyo Co., Ltd.
Overview:
Daiichi Sankyo, a Japanese multinational pharmaceutical company, is the original innovator of ACTOPLUS MET. The company developed and marketed the drug, leveraging its extensive research and development capabilities.
Market Presence:
Daiichi Sankyo maintains manufacturing and distribution agreements with various regional partners to ensure availability.
Supply Factors:
Daiichi Sankyo’s manufacturing facilities are GMP-certified, adhering to global standards, with robust quality assurance protocols. Direct procurement from Daiichi Sankyo provides assurance of product authenticity.
2. Crystallife Pharmaceuticals (India)
Overview:
Crystallife is a pharmaceutical company based in India specializing in the manufacture of generic diabetes medications, including combinations like ACTOPLUS MET.
Manufacturing Capabilities:
Crystallife’s facilities are GMP-certified, with production capacity aligned to meet domestic and export demands. They primarily source active ingredients (Alogliptin and Metformin) from reliable API suppliers.
Market Position:
India is a major hub for generic pharmaceutical manufacturing, and Crystallife supplies ACTOPLUS MET to various countries under licensing agreements or direct export.
3. Hetero Drugs Limited (India)
Overview:
Hetero Drugs is a leading Indian pharmaceutical manufacturer, recognized for producing high-quality generic medications, including diabetes compounds.
Supply Chain:
Hetero manufactures ACTOPLUS MET either directly or via partnerships, utilizing APIs from certified suppliers to maintain product quality.
Exclusivity and Licensing:
Hetero may hold licensing rights for ACTOPLUS MET in specific markets, expanding its supply scope.
4. Other Regional Generic Manufacturers
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Lupin Limited (India):
Known for producing combination therapies, including ACTOPLUS MET, primarily for Asian markets.
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Cipla Limited (India):
Offers generic versions of combination diabetic medications, with potential manufacturing capacity for ACTOPLUS MET through licensing or direct production.
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Zhejiang Dison Pharmaceutical Co., Ltd. (China):
Develops DPP-4 inhibitors and combination products for domestic and export markets.
Active Pharmaceutical Ingredient (API) Suppliers
The stability of the ACTOPLUS MET supply chain heavily depends on the reliable sourcing of APIs. The two primary APIs involved are:
1. Alogliptin (DPP-4 Inhibitor)
Leading API Manufacturers:
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Nichi-Iko Pharmaceutical Co., Ltd. (Japan):
A prominent supplier of Alogliptin API, adhering to strict quality standards.
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Hetero Labs (India):
Supplies Alogliptin API for regional markets, with GMP certification.
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Zhejiang Huahai Pharmaceutical (China):
Offers competitive API manufacturing with a significant export footprint.
2. Metformin (Biguanide)
Major API Providers:
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Payal Sun Pharma (India):
A key manufacturer of Metformin API for export.
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Hetero Labs (India):
Likewise supplies high-quality Metformin API.
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BASF SE (Germany):
Supplies pharmaceutical-grade Metformin, often for high-end formulations.
Regulatory and Quality Considerations
The quality and regulatory compliance of suppliers are critical. Manufacturers must comply with international standards such as WHO GMP, US FDA cGMP, and EMA standards. The following are crucial considerations:
- GMP Certification: Ensures manufacturers adhere to Good Manufacturing Practices.
- Bioequivalence and Stability Data: Suppliers must provide documentation supporting product consistency.
- Regulatory Approvals: Products must be approved by respective health authorities for regional sales.
Market Dynamics and Supplier Selection Criteria
The competitive landscape for ACTOPLUS MET security relies on:
- Regulatory Compliance: Suppliers with WHO or GMP certifications are preferred.
- Cost-efficiency: India and China dominate due to lower manufacturing costs.
- Supply Stability: Long-term relationships with API and formulation providers mitigate shortages.
- Quality Assurance: Certificates of Analysis (CoA), batch records, and audit reports influence supplier choice.
Conclusion
The supply ecosystem for ACTOPLUS MET involves a mix of original developers, regional generic manufacturers, and API suppliers. While Daiichi Sankyo remains the primary innovator and supplier in markets where it retains rights, Indian and Chinese generic manufacturers significantly contribute to global availability. Reliance on certified API manufacturers from Japan, India, and China ensures consistent product quality and regulatory compliance.
Supply chain resilience, adherence to quality standards, and competitive pricing will continue to dictate supplier relationships. For pharmaceutical companies, establishing strategic partnerships with reliable API producers and formulation manufacturers is vital to ensuring uninterrupted access to ACTOPLUS MET.
Key Takeaways
- Major manufacturers of ACTOPLUS MET include Daiichi Sankyo (original innovator), Indian firms like Crystallife and Hetero, and regional generics producers.
- APIs for ACTOPLUS MET—Alogliptin and Metformin—are predominantly sourced from certified producers in Japan, India, and China.
- Regulatory compliance, GMP certification, and supply stability are critical factors in supplier selection.
- India and China are central to the global supply chain, offering cost-effective and high-quality API manufacturing.
- Partnerships with certified API suppliers mitigate risks of shortages and quality lapses.
FAQs
1. Who are the primary suppliers of ACTOPLUS MET?
While Daiichi Sankyo produces the original product, many regional manufacturers, notably in India and China, supply generic versions, sourcing APIs from certified suppliers.
2. Are APIs for ACTOPLUS MET produced domestically or imported?
APIs are primarily imported from certified producers in Japan, India, and China, then formulated into ACTOPLUS MET by regional pharmaceutical manufacturers.
3. How does regulatory compliance influence supplier selection?
Suppliers with GMP, FDA, or EMA certifications ensure product safety, efficacy, and compliance, minimizing regulatory risks and enabling market access.
4. What role do cost factors play in the supply chain?
Cost-effective sourcing, especially from India and China, enables affordable generic production, helping meet global demand without compromising quality.
5. What future trends could impact ACTOPLUS MET suppliers?
Increasing regulatory scrutiny, patent expirations, and technological advancements in API manufacturing will influence supplier dynamics and product availability.
References
[1] Daiichi Sankyo Company Profile and Market Strategy.
[2] Global API Market Overview. IQVIA, 2022.
[3] WHO GMP Guidelines and Certifications. World Health Organization, 2021.
[4] Indian Pharmaceutical Industry Report. Department of Pharmaceuticals, India, 2022.
[5] China Pharmaceutical API Manufacturing, CPHI Insights, 2022.
