Bulk Pharmaceutical API Sources for MOXALACTAM DISODIUM

Bulk Pharmaceutical API Sources for MOXALACTAM DISODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		441242
MolPort		MolPort-003-666-237
ABI Chem		AC1L9AT9
Chembase.cn		105900

Bulk Active Pharmaceutical Ingredient (API) Sources for Moxalactam Disodium

Last updated: August 1, 2025

Introduction

Moxalactam disodium is a broad-spectrum, beta-lactam antibiotic classified within the cephalosporin group, used primarily for its efficacy against Gram-positive and Gram-negative bacteria. As a vital pharmaceutical compound, its sourcing plays a critical role in ensuring consistent supply, quality, and regulatory compliance. In the growing context of global pharmaceutical manufacturing, identifying reliable bulk API sources for moxalactam disodium is essential for stakeholders aiming to optimize procurement strategies, control costs, and mitigate supply chain risks.

Market Overview of Moxalactam Disodium

Moxalactam disodium was developed during the late 20th century and has since experienced variable demand, primarily driven by its medical application in severe infections. Its synthesis involves complex chemical pathways, including the preparation of the core cephalosporin structure, subsequent modifications, and disodium salt formation to enhance solubility and stability.

The API's production is concentrated within a handful of countries with advanced pharmaceutical manufacturing capacities, including China, India, and certain European nations. Given the complexity of synthesis and stringent quality standards—namely Good Manufacturing Practice (GMP)—product sourcing from reputable suppliers is paramount.

Leading Global Suppliers of Moxalactam Disodium API

1. Chinese API Manufacturers

China accounts for a significant share of the global API market, with numerous manufacturers producing moxalactam disodium. Reputable Chinese firms typically possess GMP certification, enabling them to export APIs globally. Notably:

• Shenzhen Aoxing Pharmaceutical Co., Ltd.
  Specializes in cephalosporin APIs, including moxalactam disodium. The company operates under strict GMP standards, with successful export certifications, particularly in Asia, Africa, and parts of Europe.

• Shandong Freda Biotechnology Co., Ltd.
  Offers bulk moxalactam disodium with extensive quality documentation. Known for competitive pricing and comprehensive quality management systems compliant with international standards.

• Zhejiang Velley Pharmaceutical Co., Ltd.
  Focuses on specialty antibiotics, including cephalosporin derivatives. Their manufacturing facilities are certified by Chinese authorities and hold ISO 9001 and GMP certifications.

2. Indian API Manufacturers

India's pharmaceutical sector is a major player in antibiotic APIs due to cost competitiveness and robust regulatory frameworks:

• Sandoz Pvt. Ltd. (Novartis)
  While primarily known for finished pharmaceuticals, Sandoz has a notable API manufacturing division with supply agreements for cephalosporins, including moxalactam disodium, under strict quality controls.

• Glenmark Pharmaceuticals
  Known for APIs procurement, manufacturing, and R&D. Their API manufacturing plants are compliant with global standards and have supplied moxalactam disodium to international markets.

• Torrent Pharmaceuticals
  Has dedicated API manufacturing units with certifications affording reliable supply of cephalosporin APIs, including moxalactam disodium.

3. European and North American Suppliers

Despite limited manufacturing for moxalactam disodium specifically in the West, some European and U.S.-based companies undertake synthesis for niche markets:

• Evonik Industries (Germany)
  Provides specialized APIs and intermediates, including cephalosporin derivatives, via partnerships with Asian manufacturers or through licensed manufacturing.

• Bachem AG (Switzerland)
  Focuses on peptide and complex APIs, with some collaboration in cephalosporin chemistry—though direct supply of moxalactam disodium may be limited or through intermediates.

4. Contract Manufacturing and Custom Synthesis

Certain multinational Contract Manufacturing Organizations (CMOs) offer custom synthesis services for moxalactam disodium, including:

• CordenPharma (Germany)
  Offers full GMP manufacturing of complex APIs including cephalosporin derivatives, capable of scale-up to commercial quantities.

• Aenova Group (Germany)
  Provides formulation, API synthesis, and packaging services for cephalosporins, with potential to supply bulk moxalactam disodium under negotiated agreements.

• Ajinomoto Bio-Pharma Services (USA)
  Equipped for complex API manufacturing; may undertake custom manufacturing of cephalosporins upon request.

Criteria for Selecting API Suppliers

When sourcing moxalactam disodium, stakeholders must evaluate:

• GMP Certification and Regulatory Compliance
  Ensuring adherence to international standards such as EMA, FDA, and WHO approvals.

• Quality Documentation
  Certificates of Analysis (CoA), stability data, batch records, and validation reports.

• Supply Chain Reliability
  Track record of consistent supply, lead times, and capacity to meet demand fluctuations.

• Pricing and Payment Terms
  Competitive costs aligned with quality standards, including considerations for tariffs and import regulations.

• Traceability and Provenance
  Transparent manufacturing history, including raw material sourcing and process controls.

Challenges in Sourcing Moxalactam Disodium

• Synthetic Complexity
  The intricate synthesis of cephalosporin APIs demands high technical expertise, which may restrict manufacturing to specialized facilities.

• Regulatory Barriers
  Ensuring APIs meet stringent global regulatory standards can limit supplier options, especially from less regulated markets.

• Intellectual Property
  While many cephalosporins are off-patent, certain manufacturing processes may still be protected, affecting licensing and sourcing.

• Market Fluctuations
  Variability in demand and production capacity can cause supply shortages, emphasizing the need for diversified supplier portfolios.

Conclusion

Global procurement of moxalactam disodium API hinges on a nuanced understanding of manufacturer capabilities, regulatory statuses, and supply chain dynamics. Leading producers are predominantly based in China and India, equipped with GMP-compliant facilities capable of delivering high-quality API at competitive prices. Collaboration with reputable CMOs or established pharmaceutical firms can mitigate supply risks and ensure manufacturing compliance.

Key Takeaways

• Chinese and Indian manufacturers dominate the moxalactam disodium API market, offering scalable, GMP-compliant production.

• Due diligence in certification, quality documentation, and regulatory compliance is essential for reliable sourcing.

• Contract manufacturing organizations offer flexible, customized solutions for large-scale procurement.

• Navigating synthetic complexity and regulatory landscapes requires a strategic approach, emphasizing supplier diversification.

• Continuous market monitoring and supplier qualification processes are critical to securing resilient supply chains.

FAQs

1. Is moxalactam disodium API readily available from multiple sources?
Yes. Although primarily produced in China and India, multiple suppliers and CMOs offer the API, supporting diversified sourcing strategies.

2. What are the key quality certifications to look for in API suppliers?
Suppliers should hold GMP certification, and where applicable, ISO 9001, European Medicines Agency (EMA) approval, or FDA validation for manufacturing processes.

3. Are there regulatory considerations unique to sourcing APIs from China or India?
Yes. Importers should verify that the API complies with local regulatory standards in their importing country, including stability testing, documentation, and inspection reports to ensure quality and safety.

4. How does the complexity of moxalactam disodium synthesis impact sourcing?
The synthetic complexity limits manufacturing to specialized facilities with advanced chemical capabilities, potentially restricting supplier options but ensuring high-quality production when sourcing from reputable manufacturers.

5. Can contract manufacturing organizations (CMOs) supply moxalactam disodium API?
Yes. Several CMOs possess the technical expertise and GMP capabilities to produce moxalactam disodium at scale, often providing alternatives or supplementing direct supplier sources.

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Sources

[1] Pharmaceutical industry analysis reports and market datasheets on cephalosporin APIs.
[2] Official certifications and documentation from leading Chinese and Indian API manufacturers.
[3] European and North American regulatory standards for pharmaceutical manufacturing.
[4] Industry databases on API manufacturing capacities and supplier profiles.