Bulk Pharmaceutical API Sources for DEXILANT

Bulk Pharmaceutical API Sources for DEXILANT

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-002-885-834
Amadis Chemical		A807399
Synblock Inc		PB33188
AbaChemScene		CS-2820
MedChemexpress MCE		HY-13662B
AKos Consulting & Solutions		AKOS025290765
BOC Sciences		138530-94-6

Bulk Active Pharmaceutical Ingredient (API) Sources for Dexilant

Last updated: July 28, 2025

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Introduction

Dexilant (dexlansoprazole) is a proton pump inhibitor (PPI) used primarily for gastroesophageal reflux disease (GERD), erosive esophagitis, and other acid-related gastrointestinal conditions. As a cornerstone of its formulation, the quality, reliability, and sourcing of its active pharmaceutical ingredient (API) are critical to manufacturing, regulatory compliance, and market stability. This report provides a comprehensive overview of the key bulk API sources for Dexilant, examining global manufacturing hubs, supply chain considerations, and market trends that influence API procurement strategies.

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Understanding Dexlansoprazole API

Dexlansoprazole is the R-enantiomer of lansoprazole, with enhanced pharmacokinetic profiles and acid suppression efficacy. Its synthesis involves complex organic chemistry processes, including chiral resolution or asymmetric synthesis, requiring high-purity intermediates and stringent quality controls. The API’s chemical complexity influences its sourcing options, emphasizing the need for certified, reliable suppliers with proven regulatory compliance.

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Major API Manufacturers for Dexilant

1. Global Pharmaceutical Contract Manufacturing Organizations (CMOs)

Contract manufacturing organizations play a pivotal role in API production, especially for high-potency compounds like Dexlansoprazole. Many CMOs operate facilities with cGMP (current Good Manufacturing Practice) compliance, ensuring API quality meets regulatory standards (FDA, EMA, etc.).

Companies such as Fujifilm Toyama Chemical and Takeda Pharmaceutical Company, the originator of Dexilant, maintain in-house API manufacturing capacities. They supply APIs directly or through authorized distribution channels, emphasizing proprietary control and quality assurance.

2. Asian API Manufacturers

Asia, particularly China and India, forms the dominant hub for bulk API synthesis and supply. Industry reports indicate numerous suppliers capable of producing Dexlansoprazole API at large scales, leveraging cost efficiencies and manufacturing expertise.

• Chinese Suppliers: Several Chinese API manufacturers, such as Zhejiang Huahai Pharmaceutical and Zhejiang Hisun Pharmaceutical, have developed capabilities to produce PPIs, including dexlansoprazole. These suppliers often showcase extensive regulatory filings, though quality validation is essential for market approval in stringent regions.

• Indian Suppliers: Firms like Strides Pharma Science, Ipca Laboratories, and Natco Pharma have developed PPI API products, with some providing dexlansoprazole. They are known for robust R&D, cost competitiveness, and compliance with global standards.

3. European API Suppliers

European manufacturers focus on high-quality, consistently compliant API production. Companies such as Biocon (India-based with European facilities) and Siegfried AG (Switzerland) supply high-grade APIs, emphasizing stringent quality controls aligned with European pharmacopoeias.

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Market Dynamics and Supply Considerations

Regulatory Factors

API suppliers serving global markets must adhere to diverse regulatory landscapes. While China and India are primary sources, manufacturers expanding into Europe and North America must secure EMA and FDA approvals or equivalence, which can impact sourcing choices.

Supply Chain Risks

The COVID-19 pandemic highlighted vulnerabilities in dependency on Asian API sources. Disruptions due to logistics, geopolitical tensions, or regulatory delays necessitate diversified sourcing strategies, including onshore manufacturing initiatives or regional manufacturing hubs.

Cost and Quality Trade-offs

Cost remains a significant factor; however, trade-offs between price and quality must be carefully navigated. Suppliers with proven quality records reduce risk of regulatory sanctions, recalls, or manufacturing delays—critical for high-value APIs like dexlansoprazole.

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Emerging Trends in API Sourcing

• Vertical Integration: Pharmaceutical firms are increasingly investing in or acquiring API manufacturing facilities to ensure supply security.
• Regional Manufacturing: Countries like the U.S. and Europe are exploring on-shoring of API production to reduce reliance on Asian sources.
• Sustainability and Green Chemistry: Suppliers adopting environmentally friendly manufacturing processes gain favor among regulatory agencies and customers.

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Conclusion

The sourcing landscape for Dexilant API is characterized by a mix of established multinational APIs, regional suppliers, and emerging manufacturers aligning with evolving regulatory and market demands. Leading suppliers include major Chinese and Indian API producers with capabilities to manufacture high-purity dexlansoprazole at scale, alongside European firms emphasizing quality compliance. Strategic selection of API sources requires balancing cost, regulatory adherence, and supply chain stability.

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Key Takeaways

• Diverse Supplier Ecosystem: Major API sources for Dexilant encompass Asian (China, India), European, and North American manufacturers.
• Regulatory Compliance is Paramount: Suppliers with validated manufacturing processes aligned with global standards mitigate risks.
• Supply Chain Resilience: Diversify sourcing to safeguard against geopolitical, logistic, or pandemic-related disruptions.
• Investing in Quality: Prioritize suppliers with proven quality track records to ensure consistent API performance and regulatory approval.
• Emerging Onshore Manufacturing: Be aware of trends toward regional API production to enhance supply chain security.

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FAQs

1. Who are the leading global suppliers of dexlansoprazole API?
Major suppliers include Chinese firms such as Zhejiang Huahai Pharmaceutical, Indian companies like Ipca Laboratories, and European entities like Siegfried AG. These companies possess the capacity to produce high-quality dexlansoprazole API conforming to international standards.

2. How do regulatory standards influence API sourcing decisions?
Regulatory standards strictly govern API manufacturing. Suppliers with validated compliance procedures, Good Manufacturing Practices (GMP), and regulatory filings streamline approval processes for finished products across markets.

3. What risks are associated with sourcing API from China or India?
Risks include regulatory non-compliance, quality variability, geopolitical tensions, and supply chain disruptions. Rigorous qualification and supplier audits mitigate these risks.

4. Are there ongoing efforts to localize API production for Dexilant?
Yes. Countries like the U.S. and members of the European Union are investing in domestic API manufacturing facilities to enhance supply security amid concerns over global supply chain dependencies.

5. What factors should manufacturers consider when selecting an API supplier for Dexilant?
Key factors include regulatory compliance, manufacturing capacity, quality control processes, consistency in supply, cost-effectiveness, and supplier reputation.

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Sources:

1. MarketWatch. "Global Proton Pump Inhibitors Market." 2022.
2. U.S. Food & Drug Administration. "Guidance for Industry: API Quality System Audit." 2021.
3. PharmaLink. "API Manufacturing in China and India." 2023.
4. European Medicines Agency. "Guidelines on Good Manufacturing Practices." 2022.
5. Industry Reports. "Global API Market Overview." 2023.