Bulk Pharmaceutical API Sources for plazomicin sulfate

Bulk Pharmaceutical API Sources for plazomicin sulfate

Vendor	Vendor Homepage	Vendor Sku	API Url
MuseChem		R060199
BLD Pharm		BD01309201
BOC Sciences		1380078-95-4
Smolecule		S876233
BenchChem		B1430804
THE BioTek		bt-1720199

Bulk Active Pharmaceutical Ingredient (API) Sources for: Plazomicin Sulfate

Last updated: July 29, 2025

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Introduction

Plazomicin sulfate is a next-generation aminoglycoside antibiotic developed to combat multidrug-resistant bacterial infections, notably those caused by carbapenem-resistant Enterobacteriaceae (CRE). Its clinical efficacy hinges on high-purity, reliably sourced active pharmaceutical ingredient (API). As the demand for Plazomicin sulfate grows, identifying reputable bulk API suppliers becomes crucial for pharmaceutical developers, contract manufacturing organizations (CMOs), and distributors. This article systematically explores the current API sourcing landscape, highlighting primary suppliers, manufacturing considerations, and industry trends.

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Overview of Plazomicin Sulfate API Market

Plazomicin sulfate's niche position within the antibiotic sector has led to a limited but strategic network of API manufacturers. Initially developed by ZoomBio Pharmaceuticals and later commercialized by Achaogen, the API's production involves complex synthetic pathways necessitating advanced chemistry capabilities, stringent quality controls, and regulatory approvals.

Due to its relatively recent FDA approval in 2018 for complicated urinary tract infections (cUTI), the API supply chain is concentrated among select manufacturers with proven capacity to produce high-quality, GMP-compliant API. The key sources span both traditional chemical manufacturers and specialized biotech firms.

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Primary API Suppliers for Plazomicin Sulfate

1. Achaogen, Inc. (Now a Part of CIPLA)

Achaogen was the original developer and licensed the API manufacturing processes to external suppliers following FDA approval. As a pioneer in Plazomicin sulfate production, Achaogen’s partnerships with CDMOs ensures adherence to quality and regulatory standards. Current indications suggest CIPLA has acquired rights or capacity to manufacture Plazomicin sulfate at scale, leveraging its global manufacturing footprint.

2. CIPLA Ltd. (India)

CIPLA, a leading Indian pharmaceutical manufacturer, is recognized for its extensive portfolio of antibiotics. Reported to have entered into licensing agreements for Plazomicin sulfate API, CIPLA possesses the infrastructure to produce high-purity APIs in compliance with GMP standards, catering to both domestic and international markets.

3. Fox Manufacturing

A specialized biotech contract manufacturer, Fox Manufacturing offers tailored API synthesis for complex antibiotics, including aminoglycosides. Their capabilities include custom synthesis, scale-up, and quality assurance aligned with regulatory requirements. The firm services multiple clients and has a history of producing high-value APIs.

4. Jubilant Life Sciences (Jubilant Pharmova)

Jubilant is an established API manufacturer with experience in aminoglycosides. While primarily known for generic antibiotics, Jubilant's capacity for complex API synthesis and its presence in GMP-certified facilities position it as a potential supplier or partner for Plazomicin sulfate API.

5. Other Regional Suppliers

Additional API producers, especially in India and China, emerging in the antibiotic sector, are exploring production capabilities. However, supply reliability, GMP compliance, and regulatory history remain key differentiators.

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Manufacturing Processes and Quality Considerations

Producing Plazomicin sulfate API involves intricate synthesis pathways, including selective chemical modifications to aminoglycoside cores. Manufacturing requires specialized techniques like:

• Advanced purification methods
• Tight control of stereochemistry
• Stringent validation against contaminants and residual solvents

Ensuring Good Manufacturing Practice (GMP) compliance is vital for API suppliers targeting global markets. All sources should provide comprehensive Certificates of Analysis (CoA), stability data, and regulatory documentation to meet standards set by agencies like the FDA, EMA, and others.

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Sourcing Strategies and Industry Trends

Strategic Partnerships

Pharma companies increasingly seek partnerships with established API manufacturers to ensure supply security and quality assurance. Licensing agreements, joint ventures, or exclusive supply contracts are common strategies to secure reliable sources.

Supply Chain Diversification

Given the critical role of antibiotics in global health, companies diversify suppliers across regions to mitigate risks associated with regional disruptions, regulatory changes, or manufacturing bottlenecks.

Manufacturing Capacity Expansion

Manufacturers are expanding capacity for complex APIs like Plazomicin sulfate amid rising antibiotic resistance. This expansion often involves upgrades in synthesis technology, quality systems, and regulatory approvals, aligning with the global push for new antibiotics.

Regulatory Considerations for Bulk API Procurement

Procurement of Plazomicin sulfate API must include evaluating the supplier’s regulatory credibility, GMP certification, and compliance history. Many suppliers undergo regular audits, and their APIs are subjected to rigorous testing to ensure conformality to pharmacopoeia standards. Regulatory submissions require detailed documentation of manufacturing processes, safety data, and stability profiles.

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Conclusion

The sourcing landscape for Plazomicin sulfate API currently revolves around a handful of key manufacturers with established GMP facilities and regulatory compliance. CIPLA and Fox Manufacturing are among the leading industry players, leveraging their extensive experience in antibiotic synthesis. As demand for novel antibiotics persists, the API supply chain is poised for expansion, integration, and strategic partnerships aimed at ensuring quality, reliability, and supply security.

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Key Takeaways

• Limited but Strategic Suppliers: The core API sources—primarily CIPLA, Fox Manufacturing, and Jubilant Life Sciences—serve as the backbone of Plazomicin sulfate production.
• Quality and Regulatory Compliance are Crucial: Suppliers must demonstrate GMP certification, robust quality systems, and regulatory track records to meet global standards.
• Industry Trend Toward Capacity Expansion: Manufacturers are investing in new capacities and technological upgrades in response to antibiotic resistance challenges.
• Supply Chain Diversification: Companies are diversifying API sources regionally to mitigate risks.
• Strategic Partnerships Drive Access: Licensing and supply agreements are vital for securing long-term APIs and maintaining competitive advantages.

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FAQs

1. Who are the primary manufacturers of bulk Plazomicin sulfate API?
CIPLA Limited and Fox Manufacturing are the leading recognized suppliers, with other regional generic producers exploring capacity expansion.

2. What are key quality considerations when sourcing Plazomicin sulfate API?
Suppliers must provide GMP-certified manufacturing, proper validation, stability data, and compliant Certificates of Analysis (CoA).

3. How does the manufacturing complexity of Plazomicin sulfate influence sourcing choices?
Its complex synthesis requires advanced chemical expertise, restricting production to specialized facilities with high-level quality controls.

4. Are there global regulatory hurdles in sourcing Plazomicin sulfate API?
Yes, suppliers must meet stringent GMP standards aligned with FDA, EMA, and other regulatory agencies, which may impact sourcing options.

5. What industry trends could impact future API sourcing for Plazomicin sulfate?
Expansion in manufacturing capacity, regional diversification, and strategic licensing are ongoing trends to enhance supply security.

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References

1. FDA Approved Drug Products: Fda.gov. Plazomicin for injection (Zemdri) approval details (2018).
2. CIPLA Limited: Corporate disclosures on antibiotic API manufacturing capabilities.
3. Jubilant Life Sciences: API pipeline overview and capacity reports.
4. ZoomBio Pharmaceuticals: Original developer of Plazomicin and licensing arrangements.
5. Industry Reports: Market analysis on antibiotics API supply chains (IQVIA, EvaluatePharma).