Suppliers and packagers for generic pharmaceutical drug: LEVOFLOXACIN

LEVOFLOXACIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare Corp	LEVOFLOXACIN	levofloxacin	INJECTABLE;INJECTION	091436	ANDA	Baxter Healthcare Corporation	36000-045-01	20 mL in 1 VIAL, SINGLE-USE (36000-045-01)	2013-07-01
Eugia Pharma	LEVOFLOXACIN	levofloxacin	INJECTABLE;INJECTION	202328	ANDA	Eugia US LLC	55150-156-20	1 VIAL, SINGLE-USE in 1 CARTON (55150-156-20) / 20 mL in 1 VIAL, SINGLE-USE	2013-01-24
Eugia Pharma	LEVOFLOXACIN	levofloxacin	INJECTABLE;INJECTION	202328	ANDA	Eugia US LLC	55150-157-30	1 VIAL, SINGLE-USE in 1 CARTON (55150-157-30) / 30 mL in 1 VIAL, SINGLE-USE	2013-01-24
Gland	LEVOFLOXACIN	levofloxacin	INJECTABLE;INJECTION	205540	ANDA	Gland Pharma Limited	68083-394-01	1 VIAL, SINGLE-DOSE in 1 CARTON (68083-394-01) / 20 mL in 1 VIAL, SINGLE-DOSE	2020-04-22
Gland	LEVOFLOXACIN	levofloxacin	INJECTABLE;INJECTION	205540	ANDA	Gland Pharma Limited	68083-395-01	1 VIAL, SINGLE-DOSE in 1 CARTON (68083-395-01) / 30 mL in 1 VIAL, SINGLE-DOSE	2020-04-22
Eugia Pharma	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	206919	ANDA	Eugia US LLC	55150-243-46	24 POUCH in 1 CARTON (55150-243-46) / 1 BAG in 1 POUCH / 50 mL in 1 BAG	2016-02-10
Eugia Pharma	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	206919	ANDA	Eugia US LLC	55150-244-47	24 POUCH in 1 CARTON (55150-244-47) / 1 BAG in 1 POUCH / 100 mL in 1 BAG	2016-02-10

Levofloxacin API Suppliers and Manufacturing Landscape

Last updated: February 19, 2026

This report details key manufacturers and suppliers of levofloxacin active pharmaceutical ingredient (API), essential for the production of the fluoroquinolone antibiotic. The analysis focuses on production capacity, regulatory standing, and geographic distribution to inform supply chain strategies for pharmaceutical companies.

What are the Primary Levofloxacin API Manufacturing Regions?

The global manufacturing of levofloxacin API is concentrated in Asia, with India and China dominating production volume. Europe also contributes, though at a smaller scale.

• India: Holds a significant share of the global levofloxacin API market due to its established pharmaceutical manufacturing infrastructure, cost competitiveness, and skilled workforce.
• China: Another major producer, benefiting from large-scale chemical synthesis capabilities and government support for the pharmaceutical sector.
• Europe: While less dominant in bulk API production, European manufacturers focus on high-purity grades and specialized formulations, often catering to stringent regulatory markets.

Who are the Leading Levofloxacin API Suppliers?

Several companies are recognized as major suppliers of levofloxacin API, characterized by their production volume, adherence to quality standards, and market presence.

Key Suppliers:

• Saturn Pharma Private Limited (India): A significant Indian manufacturer with substantial production capacity for levofloxacin hemihydrate. The company holds GMP certifications and supplies to multiple international markets. Its production facilities are located in Gujarat, India.
• Sun Pharmaceutical Industries Ltd. (India): One of India's largest pharmaceutical companies, Sun Pharma produces levofloxacin API through its integrated manufacturing network. It adheres to strict quality control measures and regulatory compliance for its global supply chain.
• Zydus Lifesciences Limited (formerly Cadila Healthcare) (India): This Indian pharmaceutical giant is involved in the manufacturing of levofloxacin API. The company has a strong regulatory compliance record and exports its products to regulated markets worldwide.
• Dr. Reddy's Laboratories Ltd. (India): A prominent Indian pharmaceutical company with capabilities in API manufacturing, including levofloxacin. Dr. Reddy's operates multiple manufacturing sites compliant with international standards.
• Lupin Limited (India): Lupin is a global pharmaceutical company that manufactures and supplies levofloxacin API. Its API division is known for its quality and regulatory adherence, serving both domestic and international markets.
• Teva Pharmaceutical Industries Ltd. (Israel): As a global leader in generic pharmaceuticals, Teva is a significant producer and supplier of levofloxacin API, often integrating its API production with its finished dosage form manufacturing.
• Hikma Pharmaceuticals PLC (UK): Hikma manufactures a range of APIs, including those for antibiotics like levofloxacin, serving markets in North America, Europe, and the Middle East.
• Chemigem S.p.A. (Italy): A European manufacturer of APIs, Chemigem has capabilities in complex organic synthesis, including fluoroquinolone derivatives.
• Jiangsu Aosaikang Pharmaceutical Co., Ltd. (China): A major Chinese pharmaceutical enterprise with substantial API production, including levofloxacin. The company emphasizes R&D and compliance with international quality standards.
• Fujian Nanping Chemical Pharmaceutical Co., Ltd. (China): This Chinese company is a notable producer of levofloxacin API, leveraging its chemical synthesis expertise.

What are the Regulatory Requirements for Levofloxacin API?

Manufacturers of levofloxacin API must comply with stringent regulatory standards to ensure product quality, safety, and efficacy. These requirements are primarily governed by pharmacopoeias and national regulatory agencies.

Key Regulatory Aspects:

• Good Manufacturing Practices (GMP): Compliance with GMP guidelines is mandatory. This includes detailed protocols for facility design, equipment, personnel training, process validation, quality control, and documentation. Authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) enforce GMP.
• Pharmacopoeial Standards: Levofloxacin API must meet the specifications outlined in major pharmacopoeias, including:
  • United States Pharmacopeia (USP): Sets standards for identity, strength, quality, and purity.
  • European Pharmacopoeia (Ph. Eur.): Defines similar quality parameters for the European market.
  • Japanese Pharmacopoeia (JP): Provides Japanese national standards.
  • Indian Pharmacopoeia (IP): Sets standards relevant to the Indian market.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies (e.g., FDA). A DMF provides detailed information about the manufacturing process, facilities, and quality control of the API. It allows drug product manufacturers to reference the DMF in their marketing applications without disclosing proprietary API information.
• Certificates of Suitability (CEP): Issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM), a CEP confirms that an API complies with the relevant monograph of the European Pharmacopoeia. This simplifies the regulatory process for companies using the API in their marketing authorization applications within Europe.
• Inspections and Audits: API manufacturing sites are subject to regular inspections by regulatory authorities (FDA, EMA, etc.) and audits by their pharmaceutical clients.

What is the Production Process for Levofloxacin API?

The synthesis of levofloxacin involves multiple chemical steps, typically starting from quinolone precursors. The process demands precise control of reaction conditions to ensure high purity and yield.

General Synthesis Route:

1. Starting Materials: The synthesis commonly begins with a precursor such as 7-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid ethyl ester or similar intermediates.
2. Nucleophilic Substitution: A key step involves the nucleophilic displacement of the chlorine atom at the C-7 position with a piperazine derivative, specifically (S)-(-)-2-aminomethyl-1-methylpiperazine, which introduces the chiral center crucial for levofloxacin's activity.
3. Hydrolysis: The ester group at the C-3 position is hydrolyzed to yield the carboxylic acid.
4. Purification: The crude levofloxacin is then subjected to purification processes, often involving crystallization. Levofloxacin is typically produced and supplied as levofloxacin hemihydrate, requiring controlled hydration.
5. Quality Control: Each batch undergoes rigorous testing to confirm identity, purity (including enantiomeric purity to ensure it is the (S)-enantiomer and to limit the R-enantiomer, ofloxacin), assay, and absence of impurities.

Critical Parameters:

• Chiral Purity: Maintaining high enantiomeric purity (>99%) for the (S)-enantiomer is paramount.
• Impurity Profile: Strict control over process-related impurities and potential degradation products is essential.
• Crystallization and Hydration: Controlled crystallization conditions are necessary to achieve the desired particle size distribution and consistent hydrate form.

What are the Market Dynamics for Levofloxacin API?

The levofloxacin API market is influenced by several factors, including the prevalence of bacterial infections, regulatory changes, and competitive pricing.

Key Market Drivers and Constraints:

• Increasing Incidence of Bacterial Infections: A primary driver for levofloxacin demand is its broad-spectrum antibacterial activity against Gram-positive and Gram-negative bacteria, making it a vital treatment for respiratory tract infections, urinary tract infections, and skin infections.
• Generic Competition: Levofloxacin is an off-patent drug, leading to intense competition among API manufacturers. This competition exerts downward pressure on API prices.
• Regulatory Scrutiny: Increased regulatory oversight regarding API quality, impurity limits, and manufacturing standards can impact supply chains and necessitate investment in compliance.
• Development of Antibiotic Resistance: Growing concerns about antibiotic resistance may lead to more cautious prescribing of fluoroquinolones, potentially moderating demand growth. However, levofloxacin remains a critical option for certain resistant infections.
• Supply Chain Resilience: Pharmaceutical companies increasingly focus on diversifying their API suppliers to mitigate risks associated with geopolitical instability, natural disasters, or single-source dependencies.
• Emerging Markets: Growing healthcare access and rising diagnosis rates in emerging economies contribute to demand for essential antibiotics like levofloxacin.

What are the Supply Chain Considerations for Pharmaceutical Companies?

For pharmaceutical companies manufacturing or sourcing levofloxacin-based finished drug products, robust supply chain management is critical.

Strategic Considerations:

• Supplier Qualification: Thoroughly vet potential API suppliers. This involves assessing their regulatory compliance history, GMP certifications, quality control systems, production capacity, financial stability, and track record for delivering consistent quality.
• Geographic Diversification: Avoid over-reliance on a single geographic region for API sourcing. Establishing relationships with suppliers in different continents (e.g., India, China, Europe) can enhance supply chain resilience.
• Contractual Agreements: Implement comprehensive supply agreements that clearly define quality specifications, delivery timelines, pricing, audit rights, change control procedures, and business continuity plans.
• Inventory Management: Maintain adequate inventory levels of API to buffer against unexpected supply disruptions, while also managing carrying costs. Just-in-time (JIT) strategies may be less suitable for critical APIs.
• Regulatory Intelligence: Stay informed about evolving regulatory requirements in target markets, including any changes to pharmacopoeial monographs or impurity thresholds for levofloxacin.
• Audit and Monitoring: Conduct regular audits of key suppliers and continuously monitor their performance against agreed-upon metrics. Establish open communication channels for timely issue resolution.
• Quality Agreements: Ensure detailed Quality Agreements are in place with API suppliers, outlining specific responsibilities for quality control, release testing, batch traceability, and handling of deviations.

Key Takeaways

• Levofloxacin API manufacturing is heavily concentrated in India and China, with established players in Europe.
• Major suppliers include Sun Pharma, Dr. Reddy's, Lupin, Teva, and Chinese entities like Jiangsu Aosaikang.
• Adherence to GMP, USP, Ph. Eur., and other pharmacopoeial standards is non-negotiable, supported by DMF filings and CEPs.
• The synthesis is chemically complex, requiring stringent control over chiral purity and impurity profiles.
• Market dynamics are driven by infection rates but constrained by generic competition and antibiotic resistance concerns.
• Pharmaceutical companies must prioritize supplier qualification, geographic diversification, robust contracts, and continuous quality monitoring to ensure a secure levofloxacin API supply chain.

Frequently Asked Questions

What is the typical lead time for procuring levofloxacin API from major suppliers?

Lead times can vary significantly based on supplier capacity, current market demand, and order volume. Generally, for established suppliers with consistent production, lead times for bulk orders can range from 4 to 12 weeks. This includes production, quality control release, and logistics. For new or specialized orders, lead times can extend.

How can a company assess the enantiomeric purity of levofloxacin API from a new supplier?

Assessment involves requesting analytical data from the supplier, specifically a Certificate of Analysis (CoA) that details the enantiomeric purity using validated chiral chromatography methods (e.g., HPLC with a chiral stationary phase). It is also advisable for the receiving company to perform independent testing of incoming batches to verify the supplier's data.

What are the major impurities to monitor in levofloxacin API?

Key impurities to monitor include the R-enantiomer (ofloxacin), process-related impurities arising from synthetic intermediates, degradation products, and residual solvents. Regulatory bodies and pharmacopoeias specify acceptable limits for these impurities.

Are there any specific environmental regulations that levofloxacin API manufacturers must comply with?

Yes, API manufacturers worldwide, including those producing levofloxacin, must adhere to local and international environmental regulations concerning chemical waste disposal, air emissions, and water discharge. This includes managing hazardous byproducts from chemical synthesis.

What is the typical shelf life of levofloxacin API?

The typical shelf life for levofloxacin API, when stored under recommended conditions (e.g., protected from light and moisture, at controlled room temperature), is generally between two to five years. Specific shelf life is determined by stability studies conducted by the manufacturer and is indicated on the product's CoA and labeling.

Citations

1. European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP). EDQM.
2. U.S. Food & Drug Administration. (n.d.). Drug Master Files (DMFs). FDA.
3. United States Pharmacopeial Convention. (n.d.). Levofloxacin. USP-NF.
4. European Directorate for the Quality of Medicines & HealthCare. (n.d.). Levofloxacin Hemihydrate. Ph. Eur.
5. Various Company Websites and Public Filings (e.g., Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories Ltd., Lupin Limited, Teva Pharmaceutical Industries Ltd., Jiangsu Aosaikang Pharmaceutical Co., Ltd., F Fujian Nanping Chemical Pharmaceutical Co., Ltd.).