Bulk Pharmaceutical API Sources for CIPROFLOXACIN EXTENDED RELEASE

Bulk Pharmaceutical API Sources for CIPROFLOXACIN EXTENDED RELEASE

Vendor	Vendor Homepage	Vendor Sku	API Url
Vitas-M Laboratory		STK021082
Molport		MolPort-000-819-654
Hangzhou APIChem Technology		AC-7613

Bulk Active Pharmaceutical Ingredient (API) Sources for: CIPROFLOXACIN EXTENDED RELEASE

Last updated: July 30, 2025

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Introduction

Ciprofloxacin Extended Release (ER) is a broad-spectrum fluoroquinolone antibiotic widely prescribed for various bacterial infections, including urinary tract, respiratory, and skin infections. As with all pharmaceuticals, the quality, purity, and supply chain integrity of its Active Pharmaceutical Ingredient (API) are crucial factors influencing drug efficacy, safety, regulatory compliance, and market competitiveness. This report provides a comprehensive overview of reliable bulk API sources for Ciprofloxacin ER, emphasizing global manufacturers, quality standards, sourcing strategies, and critical considerations for pharmaceutical developers and suppliers.

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Overview of Ciprofloxacin Extended Release API

Ciprofloxacin ER formulations utilize a specific API with controlled release characteristics, often achieved through complex formulation techniques such as matrix systems or coating processes. While the active ingredient's chemical structure remains consistent, the API quality and processing significantly impact bioavailability and therapeutic outcomes.

The API for Ciprofloxacin ER requires stringent manufacturing controls to meet pharmacopoeial specifications set by USP, EP, and JP. Ensuring consistent API sourcing from high-quality manufacturers is vital to achieving regulatory approval and maintaining product patent integrity.

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Global API Manufacturers and Suppliers

1. Major International API Producers

a. Shanghai Desano Pharmaceutical Co., Ltd. (China):
A leading manufacturer of Ciprofloxacin API with ISO and GMP certification. Desano supplies API to both domestic and international markets, emphasizing quality standards aligned with USP and EP.

b. Zhejiang Kangle Pharmaceutical Co., Ltd. (China):
Specializes in chemical synthesis of fluoroquinolones, including Ciprofloxacin. The company emphasizes rigorous quality control, and its APIs are approved by several regulatory bodies, including China FDA and GMP accreditation.

c. Zhuhai Rundu Pharmaceutical Co., Ltd. (China):
Offers high-purity Ciprofloxacin APIs with consistent batch-to-batch quality, serving regional and global pharmaceutical companies.

d. Sandoz (Novartis):
A global leader in generic pharmaceuticals, Sandoz produces Ciprofloxacin API meeting strict international standards (GMP, EMA, FDA). Their supply chain is characterized by robust quality assurance processes and regulatory compliance.

e. Teva Pharmaceutical Industries Ltd.:
Offers high-quality APIs for Ciprofloxacin, blending global manufacturing standards with comprehensive quality control mechanisms.

f. Micro Labs Ltd. (India):
An established API manufacturer with GMP certification producing Ciprofloxacin API for export and domestic markets, adhering to strict quality standards.

g. Aurobindo Pharma (India):
Provides Ciprofloxacin API with certifications including USFDA, EU-GMP, and WHO-GMP, supporting its role as a key supplier in the international generic API market.

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2. Regional and Emerging API Suppliers

a. Benzo Chemicals Inc. (India):
Specializes in fluoroquinolone APIs, including Ciprofloxacin, with competitive pricing and quality certifications.

b. Himalaya Drug Company (India):
Offers Ciprofloxacin API suitable for markets emphasizing cost-effective solutions, maintaining Good Manufacturing Practice compliance.

c. Hubei Huatian Pharmaceutical Co., Ltd. (China):
Emerging manufacturer with increasing market share due to competitive pricing and expanding quality certifications.

d. Pharmaceutica (Russia):
Provides Ciprofloxacin API tailored for Eastern European and CIS markets, complying with regional regulatory standards.

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Quality Standards and Regulatory Considerations

Reliable API sources must comply with recognized pharmacopoeia standards—USP, EP, JP—and adhere to Good Manufacturing Practices (GMP). These ensure API potency, purity, residual solvents, heavy metals, and microbial contamination are within acceptable thresholds.

For companies targeting markets like the US, Europe, or Japan, API suppliers should maintain certifications such as USFDA approval, EMA certification, and adherence to ISO standards. Transparency in batch records, QC data, and stability studies further affirms API suitability.

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Supply Chain and Sourcing Strategies

a. Diversification:
To mitigate risks associated with single-source dependency, select multiple suppliers spanning different regions. This balance ensures supply continuity amidst geopolitical or logistical disruptions.

b. Qualification and Validation:
Engage in rigorous supplier qualification processes, including onsite audits, batch record reviews, and stability testing data analyses.

c. Long-term Contracts:
Establish long-term memoranda of understanding (MOUs) or supply agreements to secure bulk batches at predictable pricing and delivery schedules.

d. Quality Agreements:
Develop comprehensive quality agreements to define specifications, testing requirements, and non-conformance procedures.

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Challenges and Critical Considerations

• Regulatory Compliance: Ensuring API suppliers hold valid GMP certifications and meet the listing requirements of major regulatory agencies.
• Traceability and Transparency: Suppliers must provide detailed documentation, including analysis reports, stability data, and compliance certificates.
• Pricing and Lead Times: Cost-effectiveness versus quality trade-offs require careful evaluation, especially during fluctuating global raw material costs.
• Environmental and Ethical Standards: Prefer suppliers following sustainable practices and ethical manufacturing principles, aligning with corporate social responsibility initiatives.

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Emerging Trends in API Sourcing

• Development of Local API Manufacturing: Countries are investing in local API production to reduce dependency on imports, driven by geopolitical factors and supply chain resilience concerns.
• Focus on API Quality Innovation: Increasing emphasis on impurity profiling and residual solvent reduction to meet evolving regulatory standards.
• Digital Supply Chain Tracking: Utilizing blockchain and advanced tracking for enhanced transparency and traceability of API batches.

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Conclusion

The supply landscape for Ciprofloxacin ER API is characterized by a mix of established multinational manufacturers and emerging regional suppliers. Ensuring a reliable and high-quality API source demands meticulous qualification, compliance with international standards, and strategic sourcing approaches. Companies should prioritize partnerships with GMP-certified producers demonstrating transparency, consistency, and regulatory approval capabilities to sustain competitive advantage and meet global regulatory requirements.

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Key Takeaways

• Global suppliers such as Sandoz, Teva, and Aurobindo Pharma are established sources of Ciprofloxacin API meeting international standards.
• Regional suppliers in China and India offer cost-effective, high-quality APIs, but require thorough qualification.
• Regulatory compliance (GMP, USFDA, EMA), quality assurance, and traceability are non-negotiable criteria for supplier selection.
• Diversification and strategic partnerships mitigate supply risks amid geopolitical and logistical uncertainties.
• Evolving industry trends include localized manufacturing, enhanced quality protocols, and digital supply chain solutions.

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FAQs

Q1: What certifications should I verify when selecting a Ciprofloxacin API supplier?
Ensure suppliers hold GMP certificates aligned with major regulatory agencies such as USFDA, EMA, or PIC/S. Certificates of analysis (CoA), stability data, and audit reports further guarantee quality.

Q2: How can I mitigate supply chain risks associated with Ciprofloxacin ER API?
Diversify suppliers across regions, establish long-term contracts, perform rigorous qualification processes, and monitor geopolitical conditions affecting supply routes.

Q3: Are there regional differences in Ciprofloxacin API quality standards?
While pharmacopoeial standards aim for global consistency, regional regulatory requirements and manufacturing practices can vary, necessitating supplier verification against specific standards for markets like the US, EU, or Japan.

Q4: What factors influence the pricing of Ciprofloxacin API?
Factors include raw material costs, production scale, regulatory compliance, certification levels, and geopolitical stability. Quality often correlates with price, underscoring the importance of balancing cost with compliance.

Q5: How do emerging manufacturing trends impact API sourcing for Ciprofloxacin ER?
Global efforts toward localized API production aim to reduce dependency and improve supply resilience. Advancements in process technology also enhance impurity profiles and batch consistency, positively influencing sourcing strategies.

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References

1. United States Pharmacopeia (USP). USP General Chapter <661> Packaging Materials.
2. European Pharmacopoeia (EP). Monograph on Ciprofloxacin Hydrochloride.
3. International Pharmaceutical Regulators Forum. API Manufacturing and Quality Standards.
4. MarketInsight Reports on API Industry Trends, 2022.
5. Company websites and GMP certification disclosures from major API producers.