Bulk Pharmaceutical API Sources for delafloxacin meglumine

Bulk Pharmaceutical API Sources for delafloxacin meglumine

Vendor	Vendor Homepage	Vendor Sku	API Url
Aurum Pharmatech LLC		W-6128
MolPort		MolPort-028-754-230
CEGChem		QC-11727
A2Z Chemical		AZM13624
AKos Consulting & Solutions		AKOS025404885
ApexBio Technology		A3357

Bulk Active Pharmaceutical Ingredient (API) Sources for: Delafloxacin Meglumine

Last updated: July 31, 2025

Introduction

Delafloxacin meglumine, a novel fluoroquinolone antibiotic approved by the U.S. Food and Drug Administration (FDA) in 2017, has garnered significant attention for its broad-spectrum activity against complicated skin and skin structure infections (cSSTIs) and community-acquired pneumonia (CAP). As a synthetic compound, delafloxacin’s manufacturing depends heavily on the availability of high-quality bulk APIs. Ensuring reliable sources for bulk delafloxacin meglumine is critical for pharmaceutical companies, contract manufacturing organizations (CMOs), and supply chain stakeholders aiming to meet clinical demands and commercial production. This article evaluates current API sources, manufacturing considerations, key players, and regulatory considerations shaping the supply landscape for delafloxacin meglumine.

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Chemical Profile and Manufacturing Considerations of Delafloxacin Meglumine

Delafloxacin is a quinoline-4-carboxylic acid derivative with distinctive structural features, including a fluorinated quinolone core and an enhanced activity profile compared to earlier fluoroquinolones. Its meglumine salt form enhances water solubility, facilitating IV administration [1]. The synthesis involves complex multi-step organic processes, halogenation, amidation, and salt formation, requiring specialized chemical expertise.

Manufacturing delafloxacin meglumine on a commercial scale hinges on acquiring high-purity intermediates, optimal synthesis routes, and controlled reaction conditions. The API must meet stringent purity standards (typically > 99%) and be compliant with Good Manufacturing Practice (GMP) regulations to ensure safety and efficacy.

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Key Criteria for API Suppliers of Delafloxacin Meglumine

• GMP Certification: Essential for ensuring quality, safety, and compliance with regulatory standards.
• Supply Chain Reliability: Consistent, scalable production capacity and timely delivery.
• Certifications and Regulatory Compliance: WHO-GMP, ISO certifications, and regional approvals facilitate market access.
• Cost Competitiveness: Economical pricing without compromising quality.
• Technical Capabilities: Expertise in complex fluoroquinolone synthesis, quality control, and process validation.

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Major Global API Suppliers and Manufacturers

While the market for delafloxacin meglumine API is relatively niche, a handful of pharmaceutical ingredient suppliers have emerged as noteworthy players. These companies either manufacture delafloxacin specifically or possess the advanced chemical synthesis capabilities required for its production.

1. Cayman Chemical

Cayman Chemical is renowned for high-quality chemical intermediates and custom synthesis services in the pharmaceutical domain. Although primarily focused on research-grade compounds, they have capabilities to produce GMP-compliant APIs on demand. Their expertise in fluoroquinolone synthesis positions them as potential suppliers for delafloxacin intermediates [2].

2. Luye Pharmaceuticals

Luye Pharmaceuticals, a vertically integrated Chinese pharmaceutical company, has made strides in antibiotics manufacturing, including fluoroquinolone derivatives. They possess GMP-certified facilities and a track record of supplying APIs for international markets, suggesting potential as a bulk API provider for delafloxacin meglumine, contingent on licensing and regulatory approval [3].

3. Sino Bioway

Specializing in pharmaceutical intermediates, Sino Bioway offers advanced synthesis services, including specialty antibiotics and complex chemical intermediates. Their manufacturing infrastructure supports the production of high-value APIs, making them a candidate for delafloxacin meglumine API supply, especially for clients seeking regional manufacturing in Asia [4].

4. Privately-Owned Contract Manufacturing Organizations (CMOs)

Several CMOs worldwide, such as SciGen (Taiwan) and CordenPharma (Europe), possess the capacity for custom API synthesis and scale-up. These organizations are capable of producing delafloxacin meglumine under GMP conditions upon client demand, subject to licensing and contractual arrangements [5].

5. Contract Development and Manufacturing Organizations (CDMOs) in India and China

Given the cost advantages and expanding capacities, India-based firms like Divi's Laboratories and Hikal Ltd. are exploring opportunities in API synthesis for complex molecules, including fluoroquinolones. Chinese CDMOs such as Hengli Chemical and North China Pharmaceutical Group have similar capabilities and may become suppliers given appropriate collaborations [6].

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Regulatory and Patent Landscape Influencing API Supply

Delafloxacin’s patent exclusivity, held by Melinta Therapeutics until 2030, constrains generic manufacturing and API sourcing. Companies seeking to produce the API or enter supply chains must navigate patent protections, licensing agreements, and regional regulations. Additionally, regulatory registration of APIs must align with regional authorities such as the FDA (U.S.), EMA (Europe), and NMPA (China), influencing sourcing strategies.

Challenges and Opportunities

• Patent Landscape: Licensing arrangements are often necessary for non-originator manufacturers.
• Manufacturing Barriers: Complex synthesis routes inhibit large-scale replication without advanced technical knowledge.
• Regional Variations: API sourcing may be constrained or facilitated depending on the country’s regulatory environment and patent status.

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Supply Chain Strategies and Market Outlook

Given the specialized nature of delafloxacin meglumine API, the supply chain strategy involves selecting a trusted partner capable of ensuring quality, scale, and regulatory compliance. Securing multiple suppliers reduces dependency risks and enhances supply stability, particularly during global disruptions such as pandemics or geopolitical conflicts.

The future outlook for API sourcing hinges on patent status, technological advancements in synthesis, and market demand. As delafloxacin’s indications expand and global antibiotic resistance challenges intensify, demand for API supplies will likely grow, prompting existing suppliers to scale up and new entrants to develop manufacturing capabilities.

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Conclusion

Reliable bulk API sourcing for delafloxacin meglumine is pivotal for ongoing production and availability. Currently, high-grade suppliers include regional players in China, India, and select Western CMO providers with specialized synthesis expertise. Navigating the patent landscape, ensuring compliance, and fostering strategic partnerships will be essential for future API procurement. Stakeholders must evaluate supplier capabilities comprehensively to mitigate supply risks and support sustained market growth.

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Key Takeaways

• The manufacturing of delafloxacin meglumine API requires sophisticated synthesis processes, demanding companies with advanced chemical capabilities and GMP certification.
• Leading potential suppliers include specialized Chinese and Indian firms, alongside global CMOs with experience in complex antibiotic API production.
• Patent protections influence market access, necessitating licensing agreements or in-house synthesis development.
• Diversifying API sourcing through multiple qualified suppliers reduces supply chain risks amid geopolitical and pandemic-related disruptions.
• As delafloxacin’s therapeutic use expands, demand for high-quality, scalable API sources will intensify, incentivizing supplier capacity expansion and technological innovation.

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FAQs

1. Are there generic manufacturers of delafloxacin meglumine API?
Currently, generic manufacturing is limited due to patent protections held by Melinta Therapeutics. Licensing arrangements or patent expiry in the future could facilitate generic production.

2. What are the main challenges in synthesizing delafloxacin meglumine?
Its complex multi-step synthesis, requiring advanced chemistries such as selective halogenation and salt formation, presents challenges in yield, purity, and large-scale manufacturing.

3. How do regional regulations affect API sourcing for delafloxacin meglumine?
Regulatory standards, including GMP compliance and regional approval processes, influence the selection of suppliers and the feasibility of importing APIs into specific markets.

4. Can contract manufacturing organizations produce delafloxacin meglumine API?
Yes, skilled CMOs with relevant synthesis expertise and GMP facilities can produce delafloxacin meglumine API based on contractual arrangements, provided licensing and patent considerations are addressed.

5. What is the outlook for delafloxacin API supply in the global market?
Supply prospects are promising with increasing demand; however, capacity expansion and technological advancements are necessary to meet global needs amid patent and regulatory challenges.

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References

[1] U.S. Food and Drug Administration (FDA). FDA approves new drug to treat bacterial infections. 2017.
[2] Cayman Chemical. Chemical Synthesis Capabilities. 2022.
[3] Luye Pharmaceuticals. Product Portfolio and GMP Certification. 2022.
[4] Sino Bioway. Advanced API manufacturing services. 2022.
[5] CordenPharma. API Contract Manufacturing Capabilities. 2022.
[6] Hikal Ltd. API and Intermediates Production. 2022.