Bulk Pharmaceutical API Sources for DURACILLIN A.S.

Bulk Pharmaceutical API Sources for DURACILLIN A.S.

Vendor	Vendor Homepage	Vendor Sku	API Url
Amadis Chemical		A830119
AKos Consulting & Solutions		AKOS015896161
Molport		MolPort-019-998-469
BOC Sciences		54-35-3
OChem		14928
Key Organics/BIONET		AS-15252

Bulk Active Pharmaceutical Ingredient (API) Sources for DURACILLIN A.S.

Last updated: August 5, 2025

Overview of DURACILLIN A.S. and Its API

DURACILLIN A.S., recognized under the generic name oxacillin sodium, is a β-lactam antibiotic classified as a penicillinase-resistant penicillin. It is primarily used in the treatment of penicillinase-producing staphylococcal infections. The efficacy and safety of DURACILLIN hinge on the quality and sourcing of its active pharmaceutical ingredient (API), oxacillin sodium.

Global API Manufacturing Landscape

The landscape for sourcing oxacillin sodium APIs encompasses several regions with established pharmaceutical manufacturing capabilities:

• India: Home to leading API manufacturers specializing in antibiotics, including oxacillin sodium. Companies such as Sandoz (a Novartis division), Micro Labs, and Aarti Drugs have robust facilities that meet global GMP standards.

• China: A significant API exporter, with numerous manufacturers producing β-lactam antibiotics, including oxacillin sodium. Firms such as North China Pharmaceutical Group Corporation (NCPC) and Sichuan Kelun Pharmaceutical Co., Ltd. are notable players.

• Europe and the United States: Fewer firms produce bulk oxacillin sodium due to regulatory hurdles and market size but maintain high-quality standards. Companies like Teva Pharmaceuticals and Pfizer historically had manufacturing capabilities, though market shifts have impacted their presence.

Criteria for Selecting API Suppliers

When sourcing oxacillin sodium bulk APIs for DURACILLIN A.S., several factors are paramount:

1. Regulatory Compliance: Suppliers must adhere to cGMP standards and have relevant certificates, including FDA approval (if applicable), European Medicines Agency (EMA) certifications, or equivalent.

2. Quality Certification: ISO certifications, batch consistency, and rigorous quality control processes ensure API purity, potency, and stability.

3. Capacity and Lead Times: Large-scale manufacturing with reliable lead times supports uninterrupted pharmaceutical production.

4. Cost and Pricing: Competitive pricing, factoring in tariffs and freight, influences procurement strategies.

5. Documentation and Traceability: Complete batch documentation, certificates of analysis (COA), and traceability bolster regulatory compliance.

Leading Suppliers of Oxacillin Sodium API

• Sandoz (Novartis): Offers high-quality oxacillin sodium APIs, complying with international standards. Their extensive manufacturing capacity and stringent quality controls position them as a premium supplier.

• Aarti Drugs Ltd. (India): Known for producing generic antibiotics, including oxacillin sodium, with WHO-GMP certification, suitable for global export.

• Micro Labs (India): Well-established in the antibiotic API market, Micro Labs supplies high-grade oxacillin sodium with comprehensive quality documentation.

• Sichuan Kelun Pharmaceutical Co., Ltd. (China): A major API producer with significant output capacity, adhering to Good Manufacturing Practice (GMP) and ISO standards.

• North China Pharmaceutical Group Corporation (NCPC): Engaged in a wide array of antibiotics, offering competitive pricing and reliable supply chains.

Regulatory and Quality Considerations

Procurement of oxacillin sodium APIs must strictly comply with the regulatory requirements of the intended market. For the U.S., this involves FDA registration; in Europe, EMA certification. Manufacturers must demonstrate consistent batch quality, stability data, and robust quality systems. Importantly, issues such as potential contamination or impurity profiles are critical, given the antibiotic's role.

Supply Chain Logistics

API sourcing involves managing global logistics, including freight, customs clearance, and storage conditions. Temperature-sensitive APIs like oxacillin sodium require cold chain logistics to maintain stability, underscoring the importance of reliable supplier partnerships.

Emerging Trends and Future Outlook

The antibiotic API market is evolving with increased emphasis on quality assurance, regulatory harmonization, and cost-effectiveness. Advances in antimicrobial resistance strategies may influence demand patterns for specific APIs, including oxacillin sodium. Suppliers investing in process improvements and quality assurance frameworks can better position themselves in this competitive landscape.

Conclusion

Sourcing bulk oxacillin sodium API for DURACILLIN A.S. necessitates a comprehensive assessment of suppliers' regulatory compliance, quality standards, capacity, and logistical capabilities. Leading manufacturers from India and China offer reliable, cost-effective options, provided they adhere to stringent GMP regulations and provide comprehensive documentation. Building partnerships with reputable suppliers ensures consistent API quality, regulatory compliance, and uninterrupted production.

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Key Takeaways

• The primary sources for oxacillin sodium API are established manufacturers in India and China, with quality certifications aligning with international standards.
• Regulatory compliance, quality assurance, and supply chain reliability are critical criteria for API sourcing.
• Suppliers like Sandoz, Aarti Drugs, Micro Labs, Sichuan Kelun, and NCPC are recognized for high-quality, high-capacity manufacturing.
• Strategic sourcing must involve rigorous due diligence, including certificates of analysis, regulatory status, and traceability.
• Evolving antimicrobial resistance trends may influence future API demand, stressing the importance of flexible, compliant supply chains.

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Frequently Asked Questions (FAQs)

1. What are the key regulatory considerations when sourcing oxacillin sodium API?
   Suppliers must demonstrate compliance with cGMP standards, possess relevant certifications like FDA or EMA approval, and provide complete documentation including Certificates of Analysis and stability data to meet regulatory requirements.

2. How do I ensure the quality and purity of the API?
   Verify supplier certifications, review batch tests, and conduct independent analysis or audits if necessary. Reliable suppliers should provide detailed COAs, impurity profiles, and stability data.

3. Is it feasible to source oxacillin sodium API from emerging markets?
   Yes, with appropriate quality assurance measures, many emerging market suppliers from India and China offer high-quality APIs that comply with international standards and can meet global demand.

4. What logistical factors should be considered in API procurement?
   Consider temperature sensitivity, lead times, customs clearance procedures, shipping costs, and storage conditions to maintain API integrity throughout the supply chain.

5. How might antimicrobial resistance trends impact oxacillin sodium API demand?
   Rising resistance may lead to shifting prescribing patterns and reduced demand for certain antibiotics. Continuous market analysis and flexible sourcing strategies are essential to adapt to such trends.

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Sources

1. [1] U.S. Food and Drug Administration (FDA). API Registration and Compliance Guidelines.
2. [2] European Medicines Agency (EMA). Good Manufacturing Practice (GMP) guidelines for APIs.
3. [3] Pharmaceutical Technology. “Global Antibiotic API Market Outlook,” 2022.
4. [4] Sandoz. API manufacturing standards and certifications.
5. [5] Market Report: "Antibiotic API Manufacturers in India and China," Global Industry Analysts, 2023.