CIPROFLOXACIN HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	CILOXAN	ciprofloxacin hydrochloride	OINTMENT;OPHTHALMIC	020369	NDA	Sandoz Inc	66758-071-38	3.5 g in 1 TUBE (66758-071-38)	1998-06-02
Sandoz	CILOXAN	ciprofloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019992	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-0882-0	1 BOTTLE, PLASTIC in 1 CARTON (50090-0882-0) / 5 mL in 1 BOTTLE, PLASTIC	2004-05-07
Sandoz	CILOXAN	ciprofloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019992	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-1754-0	1 BOTTLE, PLASTIC in 1 CARTON (50090-1754-0) / 2.5 mL in 1 BOTTLE, PLASTIC	2004-05-07
Sandoz	CILOXAN	ciprofloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019992	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-656-05	1 BOTTLE, PLASTIC in 1 CARTON (61314-656-05) / 5 mL in 1 BOTTLE, PLASTIC	2004-05-07
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Ciprofloxacin Hydrochloride is a broad-spectrum fluoroquinolone antibiotic extensively used to treat various bacterial infections, including urinary tract infections, respiratory infections, and skin infections. As a critical pharmaceutical ingredient (API), ciprofloxacin hydrochloride's supply chain involves multiple manufacturers, suppliers, and distributors globally. Ensuring an uninterrupted, high-quality supply chain is vital for pharmaceutical companies, healthcare providers, and regulatory compliance.

This article offers a comprehensive overview of the key suppliers and manufacturers of ciprofloxacin hydrochloride, elaborates on the global manufacturing landscape, and provides strategic insights into sourcing practices.

Global Manufacturing Landscape of Ciprofloxacin Hydrochloride

Ciprofloxacin hydrochloride is produced worldwide, primarily in regions with high pharmaceutical manufacturing capacities, including India, China, Europe, and North America. The manufacturing process involves complex chemical synthesis, requiring sophisticated facilities adhering to Good Manufacturing Practices (GMP).

Market dynamics are influenced by factors such as regulatory approvals, patent statuses, cost competitiveness, and supply reliability. The high demand for antibiotics and pharmaceutical APIs, in general, sustains a large existing supplier base, with many manufacturers also involved in producing generic versions following patent expirations.

Major Suppliers and Manufacturers

1. Indian Manufacturers

India stands as one of the dominant producers of ciprofloxacin hydrochloride, catering to both domestic and international markets. Indian suppliers are known for cost-effective manufacturing, often complying with WHO-GMP standards and increasingly obtaining approval from stringent regulatory entities like the US FDA and EMA.

Glenmark Pharmaceuticals:
An established global pharmaceutical company with robust API manufacturing capabilities, Glenmark produces ciprofloxacin hydrochloride primarily for exports. Their facilities are certified under multiple international standards.
Aurobindo Pharma:
A leading global supplier, Aurobindo offers ciprofloxacin hydrochloride with high purity standards, serving clients across North America, Europe, and Asia. Their manufacturing plants are GMP-certified, ensuring quality and compliance.
Hetero Drugs:
Known for affordable APIs, Hetero supplies ciprofloxacin hydrochloride globally, including in the US and Europe, following high-quality standards aligned with regulatory requirements.
Lupin Ltd.:
With extensive API production facilities, Lupin manufactures ciprofloxacin hydrochloride meeting international regulatory standards, emphasizing quality control and scalability.
Sun Pharmaceutical Industries:
A major Indian pharmaceutical enterprise, Sun Pharma supplies ciprofloxacin hydrochloride to a diverse client base globally, backed by rigorous quality assurance frameworks.

2. Chinese Manufacturers

China's pharmaceutical chemical sector produces significant quantities of ciprofloxacin hydrochloride, often at competitive prices. These manufacturers serve as key players for generic and bulk API supply.

Zhejiang GenaTech:
Focused on antibiotic APIs, this Chinese manufacturer is GMP-certified and supplies ciprofloxacin hydrochloride to global markets.
Jiangsu Hengrui Medicine Co., Ltd.:
An API supplier with broad antimicrobial product lines, Hengrui adheres to international standards and offers high-quality ciprofloxacin hydrochloride.
Shandong Xinhua Pharmaceutical Co.:
Supplies APIs to both domestic and international markets, including ciprofloxacin hydrochloride, with certifications compliant with global quality standards.

3. European and North American Suppliers

While manufacturing in Europe and North America is comparatively limited due to higher production costs, several companies and contract manufacturing organizations (CMOs) produce ciprofloxacin hydrochloride, primarily for high-end markets and specialized applications.

BASF SE:
A chemical giant offering pharmaceutical intermediates and APIs, including ciprofloxacin hydrochloride, with a focus on quality and compliance.
Lonza:
A Swiss-based CMO providing custom manufacturing services, including fermentation and chemical synthesis for APIs like ciprofloxacin hydrochloride, adhering to strict GMP standards.
Hoffmann-La Roche:
While primarily a diagnostic and pharmaceutical company, Roche historically engaged in antibiotic production, though their current focus has shifted; some APIs are supplied via licensing agreements.

Suppliers and Distributors

Numerous third-party distributors operate globally, sourcing ciprofloxacin hydrochloride from primary manufacturers. These distributors play a crucial role in bridging supply gaps, especially for smaller pharmaceutical companies and generic drug producers.

Alibaba and Global Sources:
Wholesalers and API brokers often list ciprofloxacin hydrochloride from Chinese manufacturers, providing varied grade options depending on application (bulk pharma, research, etc.).
Mundipharma, Lyophilized APIs:
Some specialized distributors focus on high-purity, GMP-grade ciprofloxacin hydrochloride, catering to regulated markets.

Criteria for Supplier Selection

When selecting ciprofloxacin hydrochloride suppliers, companies consider:

Regulatory Compliance:
GMP certification, FDA approval, EMA certification, and adherence to WHO standards.
Quality Standards:
High purity levels (>98%), precise pharmacopoeial specifications, and validated manufacturing processes.
Supply Reliability:
Proven track record of consistent shipment, capacity to meet large volume demands, and contingency planning.
Cost Competitiveness:
Balancing quality with competitive pricing, especially for large-scale procurement.
Lead Time and Logistics:
Efficient logistics capabilities to ensure timely delivery and minimal supply disruptions.

Emerging Trends and Strategic Considerations

Localization and Diversification:
To mitigate supply chain risks, companies increasingly diversify suppliers across geographical regions, emphasizing origins in both India and China.
Regulatory Stringency:
Suppliers are investing in GMP upgrades to meet international standards, which is critical as regulatory scrutiny intensifies globally.
Contract Manufacturing & Licensing:
Strategic partnerships and licensing agreements with established manufacturers enable access to high-quality APIs while reducing compliance risks.
Sustainability and Green Chemistry:
Growing emphasis on environmentally sustainable manufacturing processes influences supplier selection, favoring those with eco-friendly practices.

Key Challenges in Sourcing Ciprofloxacin Hydrochloride

Supply Chain Disruptions:
Global events such as the COVID-19 pandemic have strained supply networks, leading to procurement delays.
Quality Variability:
Differing standards across regions necessitate thorough supplier audits and quality verification.
Pricing Pressures:
While Indian and Chinese manufacturers offer competitive prices, maintaining quality at lower costs remains a balancing act.

Conclusion

The procurement of ciprofloxacin hydrochloride involves navigating a complex global supply network characterized by diverse manufacturers, regulatory requirements, and market dynamics. Indian and Chinese suppliers dominate the landscape, offering cost-effective solutions with varying degrees of regulatory approval. High-quality suppliers based in Europe and North America, though limited in number, provide critical options for quality-sensitive markets.

Strategic sourcing, emphasizing supplier qualification, diversification, and compliance, remains essential for pharmaceutical companies aiming to secure a reliable, high-quality supply of ciprofloxacin hydrochloride.

Key Takeaways

Global Suppliers: Top manufacturers are primarily located in India and China, with select European and North American firms offering high-regulatory-standard APIs.
Quality Assurance: Ensuring GMP compliance and high purity standards is paramount in supplier selection.
Supply Chain Risks: Geopolitical issues, pandemics, and regulatory changes can disrupt supply, requiring diversification strategies.
Cost vs. Quality: Balancing competitive pricing with stringent quality standards is critical for procurement success.
Emerging Trends: Adoption of green chemistry practices and strategic partnerships enhance supply resilience and sustainability.

FAQs

1. What are the primary regions producing ciprofloxacin hydrochloride?
India and China dominate production, offering cost-effective APIs, with European and North American suppliers providing higher regulatory-standard products.

2. How can purchasers verify the quality of ciprofloxacin hydrochloride suppliers?
By assessing GMP certifications, obtaining samples for independent testing, reviewing audit reports, and verifying regulatory approvals such as FDA or EMA certifications.

3. What factors influence the pricing of ciprofloxacin hydrochloride?
Manufacturing costs, regulatory compliance, scale of production, source country, and supply chain stability.

4. Are there any recent regulatory changes affecting ciprofloxacin hydrochloride suppliers?
Stringent quality standards from agencies like the FDA and EMA have increased the need for suppliers to maintain compliance with GMP and pharmacopoeial specifications.

5. How can companies mitigate supply chain disruptions for antibiotics like ciprofloxacin hydrochloride?
Through supplier diversification, establishing long-term contracts, engaging with multiple regions, and integrating risk management strategies like safety stock and flexible logistics.

References

[1] Pharmaceutical Technology. "Ciprofloxacin: Manufacturing and Supply Chain." (2022).
[2] World Health Organization. "Guidelines for Quality Assurance of Pharmaceutical Products." (2021).
[3] U.S. Food & Drug Administration. "GMP Regulations for APIs." (2022).
[4] MarketWatch. "Global Ciprofloxacin Hydrochloride Market Analysis." (2023).
[5] Indian Pharmaceutical Association. "API Manufacturing in India." (2021).

Suppliers and packagers for generic pharmaceutical drug: CIPROFLOXACIN HYDROCHLORIDE