FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER bulk active fine chemical vendors

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Last updated: August 4, 2025

Introduction

Floxin (ofloxacin) in dextrose 5% solution is a broad-spectrum fluoroquinolone antibiotic often used intravenously for bacterial infections. As a critical component, the quality, sourcing, and regulatory compliance of the active pharmaceutical ingredient (API), ofloxacin, are paramount for pharmaceutical manufacturers aiming to produce safe, efficacious, and compliant formulations. This article provides an in-depth analysis of the global API supply landscape for ofloxacin, specifically targeting bulk sources suitable for manufacturing Floxin in dextrose 5% in plastic containers.

Market Overview of ofloxacin API

Ofloxacin, developed in the 1980s, remains a vital antimicrobial in the treatment of respiratory, urinary tract, and soft tissue infections. The global demand for injectable antibiotics like Floxin in dextrose 5% has increased, driven by hospital settings and IV therapy protocols. As a result, a robust supply chain for high-quality ofloxacin API is essential.

The API's manufacturing and sourcing landscape includes high-volume producers primarily located in China, India, and European countries, supported by stringent regulatory environments and quality control standards. Ensuring compliance with pharmacopeial standards such as USP, EP, and JP is a fundamental requirement for APIs used in injectable products.

Key API Sourcing Countries and Manufacturers

1. China

China remains the dominant API supplier globally, accounting for a significant share of ofloxacin API production. Leading Chinese API manufacturers focus on large-scale production, adhering to international GMP standards, and often hold certifications such as ISO 9001, ISO 13485, and EMA approval.

Shanghai Hisoar Pharmaceutical Co. Ltd.: Recognized for high-quality ofloxacin API compliant with USP and EP standards. Supplies bulk API worldwide and emphasizes rigorous quality control processes.
Qingdao Sinomed Pharmaceutical Co., Ltd.: Provides ofloxacin API with export certifications; their facilities are approved by Chinese regulatory authorities and meet cGMP requirements.
Shandong Xinhua Pharmaceutical: Supplies ofloxacin API, emphasizing consistent quality and competitive pricing, primarily serving the Asian and international markets.

2. India

India hosts some of the world's largest API manufacturers, with many firms achieving WHO-GMP certification. Indian API manufacturers benefit from cost-effective production, advanced manufacturing techniques, and extensive export networks.

Aarti Drugs Ltd.: Active in API synthesis, with ofloxacin included in their portfolio, complying with USP and EP standards.
Lupin Ltd.: Recognized globally, supplies high-purity ofloxacin APIs to pharmaceutical companies for injectable formulations. Their APIs meet stringent regulatory standards.
Deva Pharmacy: Offers GMP-certified ofloxacin APIs, with a focus on quality and consistent supply for large-volume injectable products.

3. Europe

European suppliers, though smaller in volume compared to China and India, focus on premium quality, regulatory compliance, and supply chain integrity, especially for products destined for regulated markets like the US and EU.

BASF SE: Supplies pharmaceutical-grade APIs, including ofloxacin, with a focus on high purity, traceability, and compliance with international standards.
Hoffmann-La Roche: Historically involved in API manufacturing, with some APIs available for partnership under strict regulatory oversight.

4. Other Notable Suppliers

Sanner Pharma (South Korea): Offers pharmaceutical-grade ofloxacin API with a focus on quality and reliable supply.
Hetero Labs Limited (India): Provides ofloxacin API, emphasizing compliance with global regulatory requirements.

Regulatory and Quality Standards for API Suppliers

Selecting an API supplier for Floxin in dextrose 5% injection requires careful consideration of compliance and quality assurance.

GMP Certification: Essential for API manufacturers to ensure consistent quality and regulatory approval for injectable formulations.
Regulatory Approvals: Suppliers should hold approvals or inspections from agencies such as the US FDA, EMA, PMDA (Japan), or TGA (Australia).
Pharmacopoeial Compliance: APIs must meet USP, EP, or JP specifications for purity, quality, and stability.
Documentation and Traceability: Comprehensive batch records, Certificates of Analysis (CoA), and stability data are vital for GMP compliance and regulatory audits.

Supply Chain Considerations

Volume Capacity and Lead Times: Large-scale manufacturers with proven capacity ensure reliable supply chains for bulk API requirements.
Pricing and Contracting: Competitive pricing, long-term supply agreements, and flexible contracts enhance sourcing stability.
Quality Control and Testing: In-house analytical testing, third-party lab verification, and transparent documentation are non-negotiable.
Logistics and Shipping: Ensuring API stability during transit, especially for temperature-sensitive APIs, involves choosing suppliers experienced in international logistics.

Future Trends and Challenges

Regulatory Harmonization: Increased global harmonization of GMP standards simplifies sourcing from multiple regions, reducing regulatory hurdles.
Supply Chain Disruptions: Pandemic-related disruptions and geopolitical issues pose risks; diversifying suppliers mitigates dependency.
Sustainable Manufacturing: Growing emphasis on environmentally sustainable API production influences supplier selection.
Technological Advances: Adoption of continuous manufacturing and process optimization enhances API quality and consistency.

Conclusion

Sourcing high-quality ofloxacin API for the production of Floxin in dextrose 5% in plastic containers hinges on selecting reputable manufacturers complying with international GMP standards and pharmacopeial specifications. Predominantly, Chinese, Indian, and European producers supply reliably, with strategic partnerships often evolving around regulatory approval, capacity, and supply chain stability.

Pharmaceutical companies must vet API suppliers through rigorous audits, verify regulatory compliance, and consider logistical and cost factors to ensure uninterrupted, compliant manufacturing processes.

Key Takeaways

Diverse Supply Sources: Chinese and Indian manufacturers dominate the ofloxacin API landscape, supplemented by European suppliers emphasizing premium standards.
Regulatory Excellence: Ensuring API suppliers hold GMP certification and international approvals is critical for injectable quality.
Quality Assurance: Proper documentation, quality control, and traceability underpin trustworthy API sourcing.
Supply Chain Strategy: Diversification and long-term agreements minimize risk and support continuous production.
Future Focus: Adaptability to regulatory changes, sustainable manufacturing, and technological innovations will shape API sourcing strategies.

FAQs

1. What are the leading countries for sourcing ofloxacin API?
Primarily China and India, due to their large-scale production capability and cost advantages. European suppliers focus on high-quality, regulated markets.

2. How can I verify that an API supplier complies with regulatory standards?
Request GMP certificates, Certificates of Analysis (CoA), and regulatory approvals (FDA, EMA, etc.). Conduct audits if possible.

3. Are there specific quality certifications I should look for in API suppliers?
Yes, ensure GMP certification, ISO 9001/13485 certifications, and adherence to pharmacopeial standards such as USP or EP.

4. What supply chain factors are critical for API sourcing?
Capacity, lead times, logistical expertise, regulatory compliance, and reliability of the supplier’s quality control processes.

5. How does market demand influence API sourcing decisions?
High demand for injectable antibiotics prompts manufacturers to build robust supplier relationships, diversify sources, and prioritize quality and delivery reliability.

References

[1] U.S. Pharmacopeia (USP). “Ofloxacin Monograph,” USP-NF, latest edition.
[2] European Pharmacopoeia (EP). “Ofloxacin Monograph,” EP, latest version.
[3] IQVIA Institute. “Global API Market Trends,” 2022.
[4] Industry reports from PharmSource and BioPlan Associates.
[5] Regulatory database and supplier certifications, company disclosures, and audits.

This comprehensive sourcing overview aims to empower pharmaceutical manufacturing professionals with existing market intelligence, regulatory insights, and strategic considerations for procuring ofloxacin API efficiently and compliantly.

Bulk Pharmaceutical API Sources for FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER