CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lab Salvat	OTOVEL	ciprofloxacin hydrochloride; fluocinolone acetonide	SOLUTION/DROPS;OTIC	208251	NDA AUTHORIZED GENERIC	Xspire Pharma, LLC	42195-128-14	1 POUCH in 1 CARTON (42195-128-14) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE	2021-10-04
Lab Salvat	OTOVEL	ciprofloxacin hydrochloride; fluocinolone acetonide	SOLUTION/DROPS;OTIC	208251	NDA	WraSer LLC	66992-128-14	1 POUCH in 1 CARTON (66992-128-14) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE	2021-10-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

The pharmaceutical market for antibiotics and corticosteroids continues to expand, driven by global demand for effective treatments. Ciprofloxacin Hydrochloride (a broad-spectrum fluoroquinolone antibiotic) and Fluocinolone Acetonide (a potent corticosteroid) are high-demand compounds used extensively in clinical settings. Their supply chains involve numerous manufacturers, often spanning China, India, Europe, and North America, supplying both active pharmaceutical ingredients (APIs) and finished dosage forms.

This article provides a comprehensive overview of the key suppliers for Ciprofloxacin Hydrochloride and Fluocinolone Acetonide, emphasizing their global footprint, production capacity, regulatory compliance, and market positioning. Understanding supplier options aids pharmaceutical companies, formulators, and distributors in strategic sourcing and risk management.

Overview of Ciprofloxacin Hydrochloride and Fluocinolone Acetonide

Ciprofloxacin Hydrochloride is a synthetic antibiotic used in treating urinary tract infections, respiratory infections, and skin infections. It is valued for its broad-spectrum activity, pharmacokinetic profile, and clinical efficacy. The global Ciprofloxacin market is driven by rising antibiotic resistance and the need for reliable, quality-assured APIs.

Fluocinolone Acetonide belongs to the corticosteroid class, used in managing inflammatory and allergic conditions. It is often formulation-specific (e.g., intraocular implants, topical creams). The durable demand in ophthalmology and dermatology sustains its market presence.

Major Suppliers for Ciprofloxacin Hydrochloride

1. Zhejiang Kangle Pharmaceutical Co., Ltd. (China)

Profile: Leading Chinese API manufacturer with extensive expertise in fluoroquinolones.
Capabilities: Production of high-quality Ciprofloxacin Hydrochloride APIs compliant with international standards (WHO-GMP, ISO).
Supply Focus: Bulk APIs tailored for generics manufacturers worldwide.
Regulatory Status: Active in exporting to North America, Europe, and Asia; maintains certifications aligning with stringent regulatory agencies.

2. Jiangsu Hengrui Medicine Co., Ltd. (China)

Profile: A major Chinese pharmaceutical innovator and API producer with a diverse portfolio.
Capabilities: Produces Ciprofloxacin Hydrochloride API with consistent quality, backed by robust R&D.
Market Position: Known for competitive pricing, meeting international standards, and large-scale manufacturing.

3. Teva Pharmaceuticals (Israel)

Profile: Global pharmaceutical giant with API manufacturing in Israel and Europe.
Capabilities: Supplies Ciprofloxacin Hydrochloride APIs for global markets.
Regulatory Compliance: Stringent adherence to global standards, including FDA, EMA, and others.

4. Alday 2000 Ltd. (India)

Profile: Well-established Indian API manufacturer focusing on antibiotics.
Capabilities: High-volume production of Ciprofloxacin Hydrochloride API meeting cGMP standards.
Market Reach: Diverse customer base across North America, Europe, and emerging markets.

5. TCI Chemicals (Japan)

Profile: Supplier of pharmaceutical-grade chemicals, including Ciprofloxacin intermediates.
Capabilities: Offers APIs with high purity and regulatory support for quality assurance.

Key Suppliers for Fluocinolone Acetonide

1. Nile Therapeutics (USA)

Profile: Specialized in corticosteroids and ophthalmic APIs.
Capabilities: Produces Fluocinolone Acetonide suitable for intraocular implants and topical formulations.
Regulatory Status: Compliance with the US FDA, ensuring high-quality standards.

2. Hanlim Pharmaceutical Co., Ltd. (South Korea)

Profile: Leading Asian corticosteroid manufacturer.
Capabilities: Manufacturing of Fluocinolone Acetonide APIs with high purity for ophthalmic and dermatologic applications.
Certifications: ISO, GMP-certified facilities targeting international markets.

3. Zhongke Sanjian Pharmaceutical Co., Ltd. (China)

Profile: Prominent Chinese pharmaceutical ingredient company.
Capabilities: Produces Fluocinolone Acetonide with scales suitable for global regulatory markets.
Market Access: Exports to Europe, North America, and Asia.

4. Hubei Tianju Pharmaceutical Co., Ltd. (China)

Profile: API specialist in corticosteroids.
Production Volume: Capable of large-scale completion, fulfilling large orders for active pharmaceutical ingredients.

5. Sigma-Aldrich (Merck Group) — now MilliporeSigma (USA/Germany)

Profile: Global supplier of pharmaceutical raw materials.
Product Range: Offers pharmaceutical-grade Fluocinolone Acetonide for research and formulation purposes.
Quality Assurance: Meets global regulatory standards, offering a reliable supply chain.

Emerging and Notable Market Players

Yifan Pharmaceutical (China): Known for competitive pricing on both APIs.
Siegfried AG (Switzerland): Focused on high-quality corticosteroid APIs.
Mingxing Pharmaceutical (China): Expanding API portfolio in fluoroquinolones.

Key Considerations for Supplier Selection

Regulatory Compliance: Suppliers must possess cGMP, ISO certifications, and appropriate DMFs (Drug Master Files).
Quality Standards: Consistency, purity, and stability of APIs are critical for regulatory approval and therapeutic efficacy.
Supply Capacity: Large-scale manufacturers often offer better stability and can meet bulk order demands.
Pricing and Lead Times: Competitive pricing combined with reliable delivery schedules influence procurement decisions.
Regional Regulations: Suppliers with experience navigating FDA, EMA, or other authorities streamline approval processes.

Market Trends and Impact on Supplier Choice

The COVID-19 pandemic underscored the importance of secure, diversified supply chains. Countries are now focusing on strategic stockpiles and local manufacturing capabilities. This trend benefits suppliers with global footprints and robust quality assurance protocols.

Furthermore, ongoing regulatory tightening and increased scrutiny on API manufacturing practices elevate the importance of selecting suppliers with verified compliance and traceability.

Conclusion

The supply landscape for Ciprofloxacin Hydrochloride and Fluocinolone Acetonide is characterized by a mix of established global players and emerging manufacturers from China and India. Key suppliers like Zhejiang Kangle, Jiangsu Hengrui, Hanlim Pharmaceutical, and Sigma-Aldrich provide credible options for pharmaceutical companies seeking reliable, high-quality APIs. It remains essential to evaluate suppliers based on regulatory adherence, manufacturing capacity, quality assurance, and geopolitical stability to ensure uninterrupted access to these critical medicines.

Key Takeaways

Diversify Suppliers: Engage multiple suppliers across geographies to mitigate risks associated with regional disruptions.
Prioritize Regulatory Compliance: Verify certifications (GMP, ISO) and ensure DMF availability for smooth regulatory submissions.
Assess Capacity and Scalability: Choose suppliers with sufficient production scales to meet current and future demand.
Monitor Regional Policies: Stay informed on import/export regulations impacting API sourcing, especially from China and India.
Incorporate Quality and Traceability: Focus on suppliers with transparent quality control processes and traceability systems.

FAQs

1. How can I verify the legitimacy of API suppliers?
Ensure suppliers possess recognized certifications (GMP, ISO), have valid DMFs, and provide comprehensive quality documentation. Conduct audits or third-party inspections when feasible.

2. Are Chinese and Indian manufacturers reliable for pharmaceutical APIs?
Yes, many Chinese and Indian manufacturers comply with international standards and possess extensive export experience. Due diligence and verification of certifications are vital.

3. What are the key factors influencing API price fluctuations?
Raw material costs, manufacturing capacity, regulatory changes, geopolitical factors, and global demand influence API pricing.

4. How does supplier choice impact regulatory approval?
Using suppliers with established regulatory compliance and transparent quality systems facilitates smoother approval processes and reduces risk of delays.

5. Is local manufacturing of APIs a viable strategy?
Yes, local manufacturing enhances supply security, reduces logistical risks, and aligns with regulatory policies favoring regional production.

Sources:
[1] "Global API Market Analysis," Pharmatech Insights 2022.
[2] "Top API Manufacturers," Pharma IQ.
[3] "Regulatory Compliance in API Manufacturing," ICH Guidelines.
[4] "Impact of COVID-19 on Global Pharmaceutical Supply Chains," WHO Reports 2021.
[5] "Chinese Pharmaceutical Industry Overview," China National Pharmaceutical Group (Sinopharm).

Suppliers and packagers for generic pharmaceutical drug: CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE