Suppliers and packagers for baxdela

baxdela

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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

Suppliers for the Pharmaceutical Drug: Baxdela (Delafloxacin)

Last updated: July 28, 2025

Introduction

Baxdela, the brand name for delafloxacin, is a broad-spectrum fluoroquinolone antibiotic approved by the U.S. Food and Drug Administration (FDA) for the treatment of complicated skin and skin structure infections (cSSSI) and acute bacterial skin and skin structure infections (ABSSSI). As a relatively new entrant in the antibiotic market, Baxdela's supply chain is critical for ensuring availability and meeting global demand amidst rising antimicrobial resistance. This article examines the key suppliers of Baxdela, the manufacturing landscape, and factors affecting its sourcing strategy.

Manufacturers and Licensing Agreements

1. Melinta Therapeutics

Melinta Therapeutics, based in the United States, is the original manufacturer and marketer of Baxdela (delafloxacin). The company developed Baxdela as part of its portfolio of novel antibiotics targeting resistant bacterial infections. Melinta holds the proprietary rights to produce, distribute, and sell Baxdela globally, under license agreements with various manufacturing partners.

2. Contract Manufacturing Organizations (CMOs)

Given the high complexity and stringent quality standards involved in antibiotic production, Melinta relies heavily on contract manufacturing organizations (CMOs) for active pharmaceutical ingredient (API) synthesis and formulation. While specific CMO names are often confidential, prominent global players such as Patheon (a division of Thermo Fisher Scientific), Famar, and Samsung Biologics are known for fulfilling large-scale pharmaceutical manufacturing needs across the industry, including antibacterials similar to Baxdela.

3. API Suppliers

The active pharmaceutical ingredient of Baxdela, delafloxacin, is synthesized through complex chemical processes requiring high-purity raw materials. Major API suppliers for fluoroquinolone intermediates and final products include:

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Known for bulk API production of fluoroquinolones, including levofloxacin and moxifloxacin, Zhejiang Hisun leverages advanced manufacturing facilities to supply APIs for global markets.

• Shanghai Fosun Pharmaceutical (China): A significant player in API synthesis, with extensive capacity for fluoroquinuluones and other antibiotics.

• Sanofi (France): While primarily a pharmaceutical developer, Sanofi supplies some APIs and intermediates for global manufacturers, notably in fluoroquinolone segments.

• Indian API Manufacturers: Companies such as Aarti Industries, Expleogic Chemicals, and Gujarat Synthetic Chemicals produce generic fluoroquinolone APIs, including intermediates used in delafloxacin synthesis.

Note: As Baxdela is a branded product with strategic manufacturing controls, the precise API sourcing varies between licensees and global markets, often comprising a mix of domestic Chinese API producers complemented by Western manufacturing infrastructure.

Regulatory and Supply Chain Factors Affecting Suppliers

The supply chain for Baxdela is impacted by regulatory scrutiny, geopolitical considerations, and global raw material availability:

• Regulatory Compliance: Manufacturers must adhere to Good Manufacturing Practices (GMP) enforced by agencies like the FDA, EMA, and other national regulatory bodies. This compliance influences sourcing decisions and quality standards across the supply chain.

• Trade Policies: U.S.-China trade tensions and export controls can affect API sourcing from Chinese manufacturers, prompting diversification of suppliers.

• Raw Material Availability: The synthesis of delafloxacin depends on specific intermediates, with their availability fluctuating due to global supply chain disruptions, especially highlighted during the COVID-19 pandemic.

Global Distribution and Supply Chain Logistics

Melinta primarily distributes Baxdela within the United States, with licensing agreements extending to European, Asian, and other markets through regional partners. The supply chain's robustness depends on:

• Manufacturing Capacity: To meet global demand, Melinta and its partners maintain multiple manufacturing sites with scalable capacity.

• Distribution Channels: Efficient logistical networks, including cold-chain logistics where applicable, ensure a steady supply of Baxdela to hospitals and clinics worldwide.

• Stockpile and Backup Suppliers: To mitigate risks, companies maintain multiple supplier relationships and localized manufacturing agreements, ensuring continuity during disruptions.

Emerging Trends in Baxdela Supply Chain

As antimicrobial resistance accelerates, demand for novel antibiotics like Baxdela is expected to grow. Consequently:

• Strategic Partnerships: Melinta may pursue collaborations with Asian API producers to diversify supply sources and reduce reliance on limited suppliers.

• Advanced Manufacturing Techniques: Adoption of continuous manufacturing, biocatalysis, and other innovative processes could improve efficiency and reduce dependency on specific raw materials.

• Regulatory Pathways: Fast-track approvals and expanded indications may increase production requirements, prompting suppliers to enhance capacity and quality controls.

Conclusion

The supply landscape for Baxdela hinges on specialized manufacturing, robust API sourcing, and adaptive logistics. Melinta Therapeutics remains the primary developer and distributor, leveraging a network of CMOs and global API producers, notably in China and India. Ensuring supply chain resilience amid geopolitical and pandemic-related disruptions remains vital for meeting clinical needs and combating resistant bacterial infections.

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Key Takeaways

• Primary Manufacturer: Melinta Therapeutics is the central producer and distributor of Baxdela, relying on strategic global partnerships.

• API Sourcing: Major API suppliers for delafloxacin include Chinese manufacturers like Zhejiang Hisun and Shanghai Fosun, supplemented by Indian producers.

• Manufacturing Dynamics: Contract manufacturing organizations play a crucial role, adhering to strict GMP standards to ensure quality and supply continuity.

• Supply Chain Risks: Geopolitical tensions, raw material shortages, and regulatory shifts can impact Baxdela’s availability; diversification and advanced manufacturing are key strategic responses.

• Market Growth: Rising antibiotic resistance and expanding indications may increase demand, prompting manufacturers to scale up and diversify supply sources.

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FAQs

1. Who are the main suppliers of the API for Baxdela (delafloxacin)?
Major API suppliers include Chinese companies such as Zhejiang Hisun Pharmaceutical and Shanghai Fosun Pharmaceutical, along with Indian manufacturers like Aarti Industries. These entities provide the high-purity intermediates required for Baxdela synthesis, supporting global supply.

2. Is Baxdela produced solely in the United States?
While Melinta Therapeutics develops and markets Baxdela primarily in the U.S., production involves a network of contract manufacturing organizations and international API suppliers, with manufacturing capacity distributed across multiple countries to ensure supply resilience.

3. How do regulatory standards affect Baxdela supply?
Regulatory agencies, particularly the FDA and EMA, impose strict GMP requirements, necessitating rigorous quality control. These standards influence supplier selection, manufacturing practices, and cross-border logistics, aiming to ensure consistent drug quality.

4. Are there any alternative suppliers or manufacturers for Baxdela?
Currently, Baxdela's production is concentrated under Melinta’s licensing agreements. However, as demand increases, new licensing partnerships and manufacturer collaborations are likely to emerge, especially among Asian API producers.

5. What factors could disrupt Baxdela’s supply chain in the future?
Disruptions could stem from geopolitical tensions, raw material shortages, manufacturing capacity constraints, or regulatory changes. Supply chain diversification and technological innovation are strategies to mitigate these risks.

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Sources

[1] Melinta Therapeutics: Baxdela Product Information.
[2] U.S. Food and Drug Administration (FDA): Approvals and Labeling.
[3] Industry Reports on API Manufacturing in China and India.
[4] Global Supply Chain Analyses of Antibiotics.
[5] Regulatory Guidelines for GMP Compliance.