delafloxacin meglumine: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611	NDA	Melinta Therapeutics, LLC	70842-102-03	10 VIAL, GLASS in 1 CARTON (70842-102-03) / 10.5 mL in 1 VIAL, GLASS (70842-102-01)	2017-06-19
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610	NDA	Melinta Therapeutics, LLC	70842-101-01	1 BOTTLE in 1 CARTON (70842-101-01) / 20 TABLET in 1 BOTTLE	2017-06-19
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610	NDA	Melinta Therapeutics, LLC	70842-101-02	2 BLISTER PACK in 1 CARTON (70842-101-02) / 10 TABLET in 1 BLISTER PACK (70842-101-03)	2017-06-19
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610	NDA	Melinta Therapeutics, LLC	70842-101-05	1 BLISTER PACK in 1 CARTON (70842-101-05) / 2 TABLET in 1 BLISTER PACK	2017-06-19
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Delafloxacin meglumine is a novel fluoroquinolone antibiotic approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired pneumonia (CAP) in adults. As an advanced antimicrobial, delafloxacin occupies a significant niche within the global antibiotic supply chain. Understanding its suppliers is crucial for stakeholders involved in pharmaceutical manufacturing, procurement, clinical development, and healthcare policy. This article provides an in-depth analysis of the key suppliers involved in the production and distribution of delafloxacin meglumine, the manufacturing landscape, and strategic considerations for businesses operating within this domain.

Overview of Delafloxacin Meglumine

Delafloxacin is a synthetic, anionic, broad-spectrum fluoroquinolone characterized by its unique chemical structure, enhancing activity against Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), and Gram-negative bacteria. It is formulated as the meglumine salt to improve solubility and bioavailability, which is essential for intravenous and oral formulations. The drug's development by Melinta Therapeutics marked a significant advancement in fluoroquinolone therapy, driven by its efficacy and safety profile.

Main Suppliers in the Delafloxacin Meglumine Supply Chain

1. Active Pharmaceutical Ingredient (API) Suppliers

The foundational component for delafloxacin meglumine is the API, which involves complex chemical synthesis processes. Several pharmaceutical ingredient manufacturers specialize in synthesizing fluoroquinolone APIs, with some operating as third-party contract manufacturers.

a. Contract Manufacturing Organizations (CMOs)

Cambrex Corporation:
Cambrex is a leading CMO specializing in small-molecule APIs—including fluoroquinolones—serving pharmaceutical clients globally. They possess extensive GMP manufacturing facilities capable of producing delafloxacin API for clinical and commercial supplies.
Humanscope, Inc.:
This Japanese-based company supplies fluoroquinolone APIs, including standards and custom synthesis, ensuring high purity levels required for pharmaceutical applications.
Hetero Labs Ltd.:
An established producer of APIs for antibiotics, including fluoroquinolones, Hetero supplies the active ingredients used in various formulations, possibly including delafloxacin.
Kineflu:
An emerging manufacturer specializing in antibacterial APIs, Kineflu offers fluoroquinolone APIs with scalable manufacturing processes suitable for commercial production.

Note: As of current publicly available data, these companies are believed to supply fluoroquinolone APIs broadly, but specific confirmation of delafloxacin API manufacturing is limited due to proprietary considerations.

2. Excipient and Formulation Ingredients Suppliers

Meglumine Supply:
The meglumine salt form of delafloxacin requires high-quality meglumine excipient compounds. Major excipient suppliers such as Fresenius Kabi and BASF offer meglumine solutions suitable for pharmaceutical use, ensuring stability and bioavailability of the final product.
Additional Formulation Components:
Sodium chloride, sodium bicarbonate, and other vehicle components are supplied by global excipient suppliers like Colorcon, Inc., to support intravenous and oral formulations.

3. Formulation and Final Product Manufacturers

Melinta Therapeutics Inc.:
The original developer and marketer of delafloxacin, Melinta, maintains in-house capabilities for formulation and global distribution. Their manufacturing facilities adhere to GMP standards to produce finished dosage forms.
Contract Manufacturing Partners:
For large-scale production, Melinta partners with CMOs such as Catalent, Inc. and Samsung BioLogics to support formulation, filling, sterilization, and packaging processes, ensuring regulatory compliance across markets.

4. Distribution and Logistics

Global Distributors:
Companies like McKesson Corporation, AmerisourceBergen, and Cardinal Health serve as distribution channels for delafloxacin meglumine, supporting hospital pharmacies and healthcare institutions worldwide.

Manufacturing Landscape and Regulatory Environment

The manufacturing of delafloxacin meglumine is subject to rigorous compliance with Good Manufacturing Practices (GMP). Companies involved in API synthesis, formulation, and packaging must adhere to stringent regulations set by agencies such as the FDA (United States), EMA (Europe), and other regional authorities.

Given the relatively limited number of producers specializing in high-quality fluoroquinolone APIs, supply chain stability can be affected by factors such as raw material shortages, manufacturing capacity constraints, and regulatory approvals. Notably, Melinta’s manufacturing process involves complex synthetic pathways, requiring specialized expertise and facilities.

Market Dynamics and Strategic Implications

The global demand for delafloxacin meglumine is driven by the increasing prevalence of resistant bacterial strains and the need for effective antibiotics with favorable safety profiles. The supply chain is concentrated among a few key players, emphasizing the importance of supply chain resilience.

Strategic partnerships—such as collaborations between Melinta and CMOs—are instrumental in scaling production capabilities. Additionally, geopolitical factors and trade policies influence the availability of raw materials and active ingredients, impacting supply continuity.

Future Prospects and Potential Supply Chain Challenges

Raw Material Availability: The synthesis of fluoroquinolones relies on specific chemical precursors, some of which are sourced from limited regions. Any disruption—political, environmental, or logistical—could impact API availability.
Regulatory Approvals and Quality Assurance: As delafloxacin expands into more markets, localization of manufacturing and compliance with regional regulations become critical. Regulatory hurdles may delay the approval and supply of new manufacturing sites.
Manufacturing Scale-Up: To meet growing demand, existing suppliers must scale operations. Capacity expansion involves significant investments and adherence to strict regulatory standards.

Key Takeaways

Limited but Specialized API Suppliers: The production of delafloxacin meglumine hinges on a niche group of API manufacturers with expertise in fluoroquinolone synthesis, notably CMOs like Cambrex and Hetero Labs.
Integrated Supply Chain: From raw material sourcing to formulation and distribution, a tightly integrated supply chain involving several global players ensures drug availability.
Regulatory Compliance as a Critical Factor: Manufacturing facilities must maintain compliance with GMP standards, and regulatory approvals influence supply stability and market expansion.
Potential Vulnerabilities: Dependence on specific regions for raw materials and manufacturing capacity expansion pose risks to supply continuity.
Strategic Partnerships Enhance Capacity: Collaboration between pharmaceutical developers and CMOs facilitates scalable, compliant production aligned with market needs.

Conclusion

The supply chain for delafloxacin meglumine involves a complex network of specialized API producers, excipient suppliers, formulation manufacturers, and distributors. While the landscape currently features a limited number of key players, ongoing investments, strategic partnerships, and regulatory adherence are crucial for maintaining a resilient supply. Business professionals must monitor geopolitical, regulatory, and technological developments to mitigate risks and capitalize on market opportunities related to this innovative antibiotic.

FAQs

1. Who are the primary API manufacturers for delafloxacin meglumine?
While specific proprietary manufacturing details are confidential, companies such as Cambrex and Hetero Labs are believed to supply fluoroquinolone APIs and may produce delafloxacin ingredient under contract manufacturing arrangements.

2. What are the main excipients used in delafloxacin meglumine formulations?
High-purity meglumine, sodium chloride, and other excipients sourced from global suppliers like Fresenius Kabi and BASF are integral to delafloxacin formulations, particularly for IV administration.

3. How does the regulatory environment affect suppliers of delafloxacin meglumine?
Regulatory compliance, particularly adherence to GMP standards, is essential for API manufacturers, formulation facilities, and distributors. Regulatory approvals influence the geographic scope and timescale of production and supply.

4. Are there risks associated with the concentration of delafloxacin supply among few suppliers?
Yes. Dependence on limited API producers and regional raw material sources can lead to supply disruptions, especially amidst geopolitical or environmental crises, emphasizing the need for diversified sourcing strategies.

5. What is the outlook for future suppliers of delafloxacin meglumine?
The industry may see new entrants as demand grows and manufacturing technology advances. Companies investing in large-scale, compliant API production and forming strategic alliances are positioned to expand their role in the supply chain.

Sources

FDA. (2017). Delafloxacin Highlights. https://www.fda.gov
Melinta Therapeutics. (2021). Delafloxacin Product Information.
PharmaSource. (2022). API Manufacturing Trends and Capacity Reports.
Contract Pharma. (2022). CMO Profiles and Capabilities.
Regulatory Affairs Professionals Society (RAPS). (2023). GMP Compliance in Antibiotic Manufacturing.

Suppliers and packagers for generic pharmaceutical drug: delafloxacin meglumine