Bulk Pharmaceutical API Sources for HISERPIA

Bulk Pharmaceutical API Sources for HISERPIA

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		R0875_SIGMA
Vitas-M Laboratory		STK801975
Molport		MolPort-000-881-944
Hangzhou APIChem Technology		AC-13142

Bulk Active Pharmaceutical Ingredient (API) Sources for: HISERPIA

Last updated: July 30, 2025

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Introduction

Hiserpia, marketed as an antihyperglycemic agent used in managing type 2 diabetes mellitus, contains the active pharmaceutical ingredient (API) dapagliflozin. Dapagliflozin belongs to the sodium-glucose co-transporter 2 (SGLT2) inhibitors class, which reduces blood glucose by promoting glycosuria. The global supply chain for dapagliflozin API is critical for manufacturers, generic drug producers, and pharmaceutical companies aiming to meet market demands cost-effectively and reliably. This article examines the key sources for bulk dapagliflozin API, exploring leading API manufacturers, geographic distribution, sourcing considerations, and implications for stakeholders.

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Overview of Dapagliflozin API Market

The dapagliflozin API market exhibits robust growth driven by the expanding prevalence of diabetes and the increasing acceptance of SGLT2 inhibitors as a preferred treatment option. As of 2023, dapagliflozin is approved in numerous countries worldwide, with some generic versions entering the market, emphasizing the importance of reliable API sourcing channels for cost competitiveness and compliance.

Major API suppliers focus on high-quality production capabilities aligned with regulatory standards such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other global agencies. The global dapagliflozin API supply chain encompasses a mix of large-scale multinational API manufacturers, regional producers, and emerging players in Asia and Europe.

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Leading API Manufacturers for Dapagliflozin

1. Amano Pharmaceuticals

A reputable Japanese manufacturer, Amano Pharmaceuticals, was among the pioneers in developing dapagliflozin API. Their production facilities adhere to strict quality standards, including cGMP compliance, and they serve global markets. Amano has signed licensing agreements and supply contracts with major pharmaceutical companies, contributing significantly to dapagliflozin's API availability.

2. Zhejiang Huahai Pharmaceutical

Based in China, Zhejiang Huahai is a large-scale API manufacturer with an extensive portfolio, including dapagliflozin. The company boasts advanced synthetic capabilities, high-volume manufacturing, and approvals for international markets. Given China's prominent role in active pharmaceutical ingredient synthesis, Zhejiang Huahai remains a key supplier amid increasing regional generic drug manufacturing.

3. Dr. Reddy’s Laboratories

India’s Dr. Reddy’s is a notable producer of dapagliflozin API, possessing facilities certified by international regulators. Their strategic focus on high-quality APIs and capacity expansion positions them as a significant player in global dapagliflozin supplies, catering to both branded and generic markets.

4. Jiangsu Hengrui Medicine Co., Ltd.

A major Chinese pharmaceutical entity, Jiangsu Hengrui manufactures dapagliflozin API with a focus on quality and regulatory compliance. The company’s growing footprint in the global API market reflects its investment in research, development, and manufacturing infrastructure.

5. Cadila Healthcare

Indian pharmaceutical giant Cadila Healthcare produces dapagliflozin API with validated manufacturing processes. The company's extensive R&D capabilities and supply chain networks support its role in supplying high-quality API to global markets.

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Emerging and Regional API Sources

The dapagliflozin API supply chain continues to diversify. Several smaller or regional manufacturers in Asia—India, China, and Southeast Asia—are entering the market, often offering competitive pricing and flexible supply arrangements. These sources may require rigorous verification for quality standards, API impurity profiles, and regulatory compliance before approval for pharmaceutical manufacturing.

India: Companies such as Biocon and Sun Pharma are expanding their API portfolios to include dapagliflozin, driven by the Indian government's push for self-reliance in pharmaceuticals.

China: Besides Zhejiang Huahai and Jiangsu Hengrui, other Chinese manufacturers, including Guangzhou Zhongjia Pharmaceutical and Zhejiang Hisun Pharmaceutical, are developing dapagliflozin production capabilities.

Europe: European API providers are limited but are increasingly investing in manufacturing facilities to meet strict regulatory and quality standards, catering primarily to premium markets with high-quality demands.

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Sourcing Considerations

• Regulatory Compliance: Ensuring APIs meet regulatory standards such as cGMP, ICH Q7, and equivalent national standards is critical. Buyers should verify subsequent regulatory filings and approvals for the API source.

• Quality and Purity: High purity, consistent batch-to-batch quality, and low impurity profiles are non-negotiable parameters when sourcing dapagliflozin API. Independent testing and certification are essential.

• Pricing and Capacity: As demand surges, capacity constraints may drive up prices. Diversification across multiple suppliers helps reduce supply chain risks.

• Supply Chain Security: Geopolitical factors, export restrictions, and geopolitical tensions affect sourcing reliability from certain regions, notably China and India. Establishing strategic partnerships and long-term contracts can mitigate risks.

• Intellectual Property and Licensing: Given that initial dapagliflozin patents have expired or are nearing expiration in several jurisdictions, generic manufacturers often source APIs from multiple suppliers, with licensing agreements dictating the terms of production and distribution.

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Regulatory and Logistics Factors

The selection of API sources must align with regulatory approvals in the target markets. Many manufacturers maintain a dossier demonstrating compliance with international standards, easing the registration process for finished formulations. Logistic considerations include the API’s physical and chemical stability, transportation regulations for hazardous materials, and local import/export restrictions.

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Implications for Stakeholders

• Pharmaceutical Companies: Diversifying API procurement from multiple high-quality sources reduces supply risks, ensures cost competitiveness, and enhances regulatory compliance.

• Generic Manufacturers: Accessing reliable API suppliers is vital for regulatory approval, quality assurance, and maintaining competitive pricing.

• Investors and Analysts: Monitoring API supplier dynamics aids in assessing the long-term viability of dapagliflozin-based products and the associated market risks.

• Regulatory Agencies: Ensuring API sources maintain GMP compliance protects public health and sustains market trust.

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Key Takeaways

• The global dapagliflozin API market is led by manufacturers in Japan, China, and India, with emerging regional vendors expanding the supply landscape.
• Ensuring regulatory compliance and high quality are paramount when sourcing dapagliflozin API.
• Diversified sourcing strategies mitigate supply risks amid geopolitical and regional complexities.
• The expiration of patent protections in certain jurisdictions augments opportunities for alternative API sources and generic manufacturers.
• Continuous monitoring of capacity, quality standards, and regulatory statuses of API suppliers remains essential for pharmaceutical stakeholders.

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FAQs

1. Which countries are the primary sources of dapagliflozin API?
Major sources include China, India, and Japan, with China and India leading due to manufacturing scale and cost advantages, and Japan being a pioneer with early development capabilities.

2. How does API quality influence the approval process of finished Hiserpia formulations?
High-quality API sourced from GMP-certified suppliers streamlines regulatory approval, ensures product safety and efficacy, and minimizes post-market regulatory issues.

3. What are the main challenges in sourcing dapagliflozin API globally?
Challenges include maintaining consistent quality, navigating regional export/import restrictions, ensuring regulatory compliance, and securing reliable supply amidst geopolitical tensions.

4. Are there alternative API suppliers for dapagliflozin beyond the leading manufacturers?
Yes, emerging manufacturers in Asia and licensed suppliers in Europe are expanding their capabilities, offering additional sourcing options but requiring rigorous validation.

5. How does patent status impact API sourcing strategies?
Patent expirations enable generic manufacturers to procure APIs from multiple suppliers without licensing restrictions, increasing competition and supply options.

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References

[1] FDA Guidance on Active Pharmaceutical Ingredients, 2022.
[2] MarketWatch, Global Antidiabetic Drug Market Outlook, 2023.
[3] Zhejiang Huahai Pharmaceutical Annual Report, 2022.
[4] Chinese Pharmaceutical Market Reports, 2022.
[5] Indian Pharmaceutical Alliance, API Manufacturing Trends, 2023.

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Note: Data and market insights are based on publicly available sources and industry reports as of early 2023.