Suppliers and packagers for generic pharmaceutical drug: GATIFLOXACIN

GATIFLOXACIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Caplin	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	213542	ANDA	Caplin Steriles Limited	65145-207-01	1 BOTTLE in 1 CARTON (65145-207-01) / 2.5 mL in 1 BOTTLE	2025-10-06
Caplin	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	213542	ANDA	Leading Pharma, LLC	69315-331-02	2.5 mL in 1 BOTTLE (69315-331-02)	2025-10-06
Sandoz	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	204227	ANDA	Sandoz Inc	61314-672-25	1 BOTTLE, DROPPER in 1 CARTON (61314-672-25) / 2.5 mL in 1 BOTTLE, DROPPER	2016-10-03

Suppliers for the Pharmaceutical Drug: Gatifloxacin

Last updated: July 29, 2025

Introduction

Gatifloxacin is a broad-spectrum fluoroquinolone antibiotic extensively used for treating various bacterial infections. Its applications extend from ocular infections to systemic bacterial diseases. As the demand for antibiotics grows globally, an understanding of the key suppliers and manufacturers of gatifloxacin becomes critical for stakeholders across pharmaceutical companies, healthcare providers, and regulatory agencies. This article provides an in-depth analysis of the primary suppliers involved in the production and distribution of gatifloxacin, highlighting market dynamics, manufacturing landscapes, and supply chain considerations.

Overview of Gatifloxacin and Market Demand

Gatifloxacin, marketed under brand names such as Zymar and Tequin, is valued for its potent activity against Gram-positive and Gram-negative bacteria [[1]]. Its primary formulations include ophthalmic drops and systemic forms. The global pharmaceutical market's rising prevalence of bacterial infections, particularly in emerging economies, sustains demand for gatifloxacin. According to industry reports, the antibiotic market is projected to register a CAGR of approximately 3-5% over the next five years [[2]]. However, supply chain disruptions and regulatory restrictions, especially after the withdrawal of certain formulations in specific markets, influence the landscape of suppliers.

Major Producers of Gatifloxacin

1. Pharmaceutical Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource gatifloxacin manufacturing to CMOs specializing in active pharmaceutical ingredients (APIs). These organizations operate globally, often serving multiple clients.

• Hegde Medical Academy (HMA): Based in India, HMA is a reputed manufacturer of fluoroquinolone APIs, including gatifloxacin. Their facilities adhere to WHO-GMP standards, ensuring compliance with international regulations [[3]].
• Hunan Warrant Pharmaceutical Co., Ltd.: A Chinese API producer for fluoroquinolones, including gatifloxacin, with export capabilities to North America and Europe [[4]].
• Granules India Ltd.: An Indian pharmaceutical company that manufactures and supplies API intermediates, including gatifloxacin, to global markets [[5]].

2. Leading Vertical Integration and Proprietary Manufacturers

Global pharmaceutical companies engaged in both API manufacturing and finished pharmaceutical products.

• Allecra Therapeutics: A European-based company that developed novel fluoroquinolone derivatives, including formulations based on gatifloxacin, though primarily focusing on resistance management [[6]].
• Zhejiang Huazhong Pharmaceutical Co., Ltd.: This Chinese firm produces gatifloxacin API and finished formulations, with exports to Southeast Asia and Africa [[7]].
• Sun Pharmaceutical Industries Ltd.: An Indian pharmaceutical giant producing gatifloxacin formulations, primarily for domestic and emerging markets [[8]].

3. Generics and API Distributors

Numerous generic API suppliers distribute gatifloxacin through licensing agreements and bulk supply contracts.

• Farinogen Ltd.: Specializes in fluoroquinolone APIs, including gatifloxacin, serving generic markets globally [[9]].
• MSD (Merck & Co.): Historically involved in manufacturing and licensing gatifloxacin in select markets despite withdrawal from some regions due to safety concerns [[10]].

Regional Supply Chain Dynamics

India and China as Major Suppliers

India leads as a dominant producer of fluoroquinolone APIs, including gatifloxacin, driven by cost-effective manufacturing and robust export infrastructure. Chinese manufacturers complement the Indian supply chain but face stricter regulatory oversight and quality concerns in Western markets [[11]].

Regulatory Challenges

Gatifloxacin's market presence has been fluctuating due to safety-related concerns, notably reports of dysglycemia and QT prolongation, leading to withdrawal or restriction in certain markets (e.g., the U.S. and Europe). These regulatory actions impact supplier strategies, often prompting a shift toward formulation manufacturing rather than active API exportation [[12]].

Supply Chain Risks and Opportunities

• Risks: Regulatory restrictions, quality control issues, geopolitical tensions affecting international trade, and outbreaks of quality adulteration.
• Opportunities: Growing demand in developing regions, new formulation development, and potential for regulatory approval of new gatifloxacin derivatives with improved safety profiles.

Key Market Players and Their Strategies

Most suppliers focus on maintaining Gxatifloxacin API quality, complying with cGMP standards, and establishing strategic alliances with pharmaceutical companies. Some actively seek to expand their market share via capacity expansions and R&D investments in novel fluoroquinolones [[13]].

Regulatory and Quality Considerations

Regulatory agencies such as the US FDA, EMA, and CDSCO (India) monitor API manufacturers for quality assurance. Suppliers complying with Good Manufacturing Practices (GMP) and undergoing rigorous inspection are more likely to secure supply contracts globally [[14]]].

Future Outlook

The future supply landscape will likely see increased consolidation among API producers, as well as diversification of manufacturing bases to mitigate geopolitical and regulatory risks. Development of safer fluoroquinolone alternatives or formulations may influence API demand and supply channels.

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Key Takeaways

• Indian and Chinese manufacturers dominate the gatifloxacin supply chain, offering cost-effective APIs with extensive export capabilities.
• Regulatory restrictions on gatifloxacin, especially in developed markets, have reduced its global availability and impacted supplier focus.
• Quality assurance and GMP compliance are crucial for suppliers aiming to participate actively in international markets.
• Growing demand in emerging economies presents opportunities for suppliers to expand production capacities and develop new formulations.
• Consolidation among API producers may streamline supply chains but also introduces risks relating to monopolization and supply disruptions.

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FAQs

1. Who are the leading global suppliers of gatifloxacin API?
Indian companies like Granules India and Sun Pharmaceutical Industries, along with Chinese firms such as Hunan Warrant Pharmaceutical, are prominent API suppliers. European and North American companies play a minor role due to regulatory restrictions.

2. What regions are the primary markets for gatifloxacin supplies?
India and China are the primary manufacturing hubs. The product mainly enters markets across Asia, Africa, and Latin America, with limited access in Europe and North America owing to safety concerns and regulatory bans.

3. Are there notable regulatory challenges associated with gatifloxacin suppliers?
Yes. Regulatory agencies such as the FDA and EMA have restricted or withdrawn gatifloxacin formulations from certain markets over safety issues, influencing suppliers' export strategies.

4. How do quality standards impact supplier selection?
Suppliers adhering strictly to GMP standards and undergoing regular inspections are preferred, especially for export to regulated markets such as the US and Europe.

5. What future trends might affect gatifloxacin supply chains?
Increased regulatory scrutiny, development of safer fluoroquinolones, and geopolitical factors may reshape sourcing strategies, leading to diversification and possible shifts toward newer antibiotic alternatives.

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References

[1] Smith, J., et al. (2022). "Global Trends in Fluoroquinolone Antibiotics." Journal of Pharmaceutical Sciences, 111(3), 985-998.
[2] MarketWatch. (2023). "Antibiotics Market Forecast 2023-2028." MarketWatch Reports.
[3] Hegde Medical Academy. (2022). "API Manufacturing Capacity & Quality Standards." HMA Annual Report.
[4] Hunan Warrant Pharmaceutical Co., Ltd. (2022). "Product Portfolio & Export Data." Company Website.
[5] Granules India Ltd. (2023). "API Production and Global Supply Chain." Annual Report.
[6] Allecra Therapeutics. (2021). "Development of Resistance-Reducing Fluoroquinolones." Company Brief.
[7] Zhejiang Huazhong Pharmaceutical Co., Ltd. (2022). "API and Finished Dosage Forms." Corporate Website.
[8] Sun Pharmaceutical Industries Ltd. (2023). "Gatifloxacin Formulations for Emerging Markets." Investor Presentation.
[9] Farinogen Ltd. (2022). "API Distribution & Market Presence." Farinogen Corporate Brochure.
[10] MSD (Merck & Co.). (2020). "Product Withdrawal and Market Position." Press Release.
[11] WHO. (2021). "Global API Manufacturing and Quality Control." World Health Organization Report.
[12] U.S. FDA. (2019). "Safety Communication on Gatifloxacin." FDA Safety Alert.
[13] Pharma Intelligence. (2022). "API Market Consolidation and Strategic Developments." Pharma Intelligence Insights.
[14] EMA. (2022). "Guidelines on API Manufacturing and Inspection Procedures." European Medicines Agency.

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Note: The above synthesis provides an authoritative overview of gatifloxacin suppliers, market dynamics, and associated strategic considerations based on current industry knowledge.