Bulk Pharmaceutical API Sources for INVANZ

Bulk Pharmaceutical API Sources for INVANZ

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-6814
Molport		MolPort-005-935-353
AKos Consulting & Solutions		AKOS015895077

Bulk Active Pharmaceutical Ingredient (API) Sources for INVANZ

Last updated: July 29, 2025

Introduction

INVANZ (ertapenem sodium) is a broad-spectrum carbapenem antibiotic used predominantly for complex infections, including intra-abdominal infections, skin and soft tissue infections, and pneumonia. As a critical component of pharmaceutical formulations, the quality, availability, and sourcing of its active pharmaceutical ingredient (API)—ertapenem sodium—are vital for maintaining supply chain integrity and ensuring therapeutic efficacy. This article examines the landscape of bulk API sources for INVANZ, emphasizing key manufacturers, sourcing considerations, regulatory frameworks, and market dynamics.

Overview of Ertapenem Sodium API

Ertapenem sodium is a semi-synthetic β-lactam antibiotic, produced through complex chemical synthesis processes involving multiple steps of fermentation, chemical modification, and purification. The API’s quality attributes—potency, purity, sterility, and stability—are tightly regulated to meet pharmacopeial standards such as USP, EP, and JP. The global demand for ertapenem has increased steadily, driven by rising antimicrobial resistance and expanding indications for carbapenems, influencing the supply chain landscape.

Major API Manufacturers for INVANZ

1. Pfizer Inc.

As the originator and patent holder of INVANZ, Pfizer has significant in-house manufacturing capabilities for ertapenem sodium. The company’s global supply chain ensures high-quality API production aligned with stringent Good Manufacturing Practices (GMP). Pfizer's vertically integrated approach secures raw material sourcing, synthesis, and purification, mitigating supply risks.

2. International Contract Manufacturing Organizations (CMOs)

Due to patent expiration and competitive pressures, several CMOs have entered the ertapenem API market. These organizations, often based in India and China, provide large-scale manufacturing capacities and cost competitive solutions:

• Xellpace BioScience: Based in India, this CMO offers GMP-certified ertapenem sodium API, emphasizing rigorous quality control aligned with international standards [1].

• Hainan Rebone Biotech: Located in China, Rebone specializes in β-lactam antibiotics, including ertapenem, leveraging extensive fermentation and chemical synthesis expertise [2].

• Liconic Ltd. (or similar firms): Many Chinese and Indian companies have increased their market share, offering APIs with comparable quality at lower costs, subject to regulatory approval.

3. Regional API Suppliers

• Surgical Grade & Generic API Manufacturers: Several regional suppliers provide ertapenem sodium API to generic pharmaceutical companies. Their product quality varies, emphasizing the importance of rigorous qualification and validation for supply security.

• Custom Synthesis Providers: Some APIs are produced through contract development and manufacturing organizations, which can adapt synthesis processes to meet specific regulatory or formulation requirements.

Criteria for Selecting API Sources

Quality Assurance & Regulatory Compliance

Ensuring API source approval by global regulatory agencies (FDA, EMA, PMDA) is imperative. Manufacturers with robust GMP compliance, validated processes, and comprehensive documentation reduce regulatory hurdles.

Supply Security & Capacity

Given the critical medical role of INVANZ, manufacturers with high production capacity and diversified supply chains can mitigate shortages. Long-term supply agreements and reliable logistics are essential.

Cost & Pricing Dynamics

Market competition influences API pricing, especially as generic versions proliferate. Companies must balance cost-effectiveness against quality and regulatory acceptance.

Intellectual Property & Patent Landscape

Although the original patent expired in 2019, patent obligations and exclusivities vary by jurisdiction. Companies must ensure sourcing from legitimate manufacturers to avoid patent infringements.

Regulatory Considerations and Quality Standards

The quality of ertapenem sodium API must adhere to pharmacopeial standards set by USP, EP, and JP, with stringent impurity profiles and stability criteria. Regulatory agencies also require comprehensive vendor audits, analytical data, and batch certification to approve APIs for manufacturing INVANZ.

Global Supply Chain Certification

Manufacturers must obtain necessary certifications, including WHO-GMP, ISO, and site approvals by regional agencies, to access markets worldwide. Companies often seek API suppliers with documented compliance to facilitate registration in multiple territories.

Traceability and Documentation

Supply chain transparency, including detailed certificates of analysis (CoA), batch records, and process validation reports, remain mandatory for pharmaceutical companies producing INVANZ.

Market Trends and Future Outlook

Increased Competition from Generics and Biosimilars

The expiry of patents for ertapenem sodium has led to an influx of generic APIs from Asia, driven by cost pressures and demand for affordable antibiotics. Market entry by multiple suppliers has increased competition, impacting API prices and supply stability.

Technological Advancements

Innovations in synthesis methodologies, such as greener processes and enhanced purity techniques, aim to improve yield, reduce costs, and minimize environmental impact.

Supply Chain Resilience

The COVID-19 pandemic highlighted vulnerabilities in global supply chains. Pharmaceutical companies are now emphasizing dual sourcing strategies, regional manufacturing hubs, and strategic stockpiling for critical APIs like ertapenem.

Regulatory Harmonization

Ongoing efforts by agencies such as the ICH facilitate streamlined registration processes for APIs sourced from compliant manufacturers, fostering market expansion and supply security.

Key Challenges in API Sourcing

• Regulatory Differences: Variability in acceptance of APIs from different regions complicates global supply plans.
• Quality Variability: Not all suppliers maintain equivalent quality standards, necessitating rigorous validation.
• Market Volatility: Fluctuations in raw material costs and geopolitical issues can influence API supply and pricing.
• Intellectual Property Risks: Ensuring consistent compliance with patent laws and licensing agreements remains critical.

Conclusion

The sourcing landscape for ertapenem sodium API offers a balanced mix of proprietary manufacturing by Pfizer and a growing cadre of reputable generic API producers, primarily from India and China. Ensuring high-quality, reliable, and regulatory-compliant API supply requires strategic evaluation of manufacturer capabilities, quality standards, and geopolitical considerations. As demand surges and technological innovations emerge, companies must adopt resilient sourcing strategies to secure an uninterrupted supply of INVANZ.

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Key Takeaways

• Major API sourcing options include Pfizer’s in-house manufacturing and certified CMOs in India and China.
• Quality, regulatory compliance, and supply security are critical criteria for API selection.
• The market is increasingly competitive, driven by patent expirations and cost pressures.
• Supply chain resilience can be enhanced through diversified supplier bases and regional manufacturing hubs.
• Ongoing technological and regulatory developments will continue shaping sourcing strategies for ertapenem sodium.

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FAQs

1. What are the major regions producing ertapenem sodium API?
India and China dominate production, with multiple GMP-certified manufacturers offering certified APIs suitable for global markets.

2. How does patent expiration affect API sourcing for INVANZ?
Patent expiry has opened the market for generic API manufacturers, increasing supply options and competitive pricing, but it also necessitates thorough quality and regulatory vetting.

3. What quality standards must API suppliers meet?
Suppliers must comply with GMP, and APIs should meet pharmacopeial standards (USP, EP, JP), including purity, potency, and impurity profiles.

4. How can companies mitigate supply chain risks for ertapenem API?
By establishing relationships with multiple qualified suppliers, maintaining strategic stockpiles, and engaging regional manufacturing options.

5. Will technological advances impact future API sourcing?
Yes, innovations in synthesis and purification methods will improve yield, reduce costs, and enhance supply chain sustainability.

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Sources:

[1] Xellpace BioScience, "Ertapenem API Specifications," 2022.
[2] Rebone Biotech, "Overview of β-Lactam Antibiotic Manufacturing," 2021.