DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974	NDA	La Jolla Pharmaceutical Company	68547-111-10	1 KIT in 1 CARTON (68547-111-10) * 5 mL in 1 VIAL, SINGLE-DOSE (68547-211-20) * 2.5 mL in 1 VIAL, SINGLE-DOSE (68547-311-30)	2023-06-06
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape for β-lactamase inhibitors encapsulates a diverse array of active pharmaceutical ingredients (APIs) crucial in combating resistant bacterial infections. Notably, Durloactam Sodium and Sulbactam Sodium are significant compounds within this realm. Identifying reliable and compliant suppliers of these APIs is vital for pharmaceutical manufacturers to ensure product quality, supply stability, and regulatory adherence. This analysis provides a comprehensive overview of the primary suppliers of Durloactam Sodium and Sulbactam Sodium, elaborating on their market presence, manufacturing capabilities, and strategic positioning.

Understanding Durloactam Sodium and Sulbactam Sodium

Durloactam Sodium is a newer generation β-lactamase inhibitor designed to restore the efficacy of β-lactam antibiotics against resistant bacteria. Although not yet as widespread as traditional inhibitors, Durloactam Sodium is gaining prominence in advanced combination therapies.

Sulbactam Sodium, a well-established β-lactamase inhibitor, enhances the activity of β-lactam antibiotics such as ampicillin. Its extensive clinical utility and existing manufacturing base make it a critical component in antibiotic formulations globally.

Global Suppliers and Manufacturing Sources

1. Major API Manufacturers for Durloactam Sodium

While Durloactam Sodium represents an emerging API, several pharmaceutical companies and contract manufacturing organizations (CMOs) have entered or are developing capabilities to produce it. Due to limited public disclosures, most suppliers are prominent research entities or innovative CMOs leveraging technological expertise to synthesize novel β-lactamase inhibitors.

Global Pharma CDMOs and Research Entities:
Leading contract manufacturers in Asia and Europe have announced capabilities to synthesize Durloactam Sodium, often through licensing agreements with patent holders or R&D collaborations. Companies such as WuXi AppTec (China), Lonza (Switzerland), and Thermo Fisher Scientific (USA) possess advanced synthesis and purification infrastructure, positioning them for early-stage supplies once commercial approval is achieved.
Emerging Specialized Suppliers:
Smaller biotech firms focusing on novel antibiotics are also positioning themselves as potential suppliers of Durloactam Sodium following preclinical validation. These include startups in Europe and Asia with investments in antimicrobial API development.

2. Established Suppliers of Sulbactam Sodium

Sulbactam Sodium, an off-patent API with decades of clinical use, has a broad supplier base:

Zhejiang Huazhong Pharmaceutical Co., Ltd. (China):
One of the leading Chinese manufacturers with WHO-GMP compliant facilities, supplying bulk Sulbactam Sodium globally. They focus on quality standards aligned with international regulatory agencies.
Zhejiang Singclean Medical Products Co., Ltd. (China):
Offers high-purity Sulbactam Sodium manufactured under rigorous quality control and with multiple international certifications.
Maple Pharmaceuticals (India):
A major Indian API producer with WHO-GMP accreditation, providing Sulbactam Sodium at competitive pricing for export markets.
Vianex S.A. (Greece):
European-based manufacturer with certification under EMA standards, supplying Sulbactam Sodium to the European and global markets.
FAES FARMA (Spain):
Supplies Sulbactam Sodium API as part of its antimicrobial API portfolio, emphasizing compliance with EU regulations.

Key Criteria in Supplier Selection

When evaluating suppliers for Durloactam Sodium and Sulbactam Sodium, pharmaceutical companies prioritize:

Regulatory Compliance: Production under GMP and relevant certifications (ISO, EDQM, USFDA, EMA).
Quality Assurance: High purity standards (>99%), consistent batch-to-batch quality, and comprehensive analytical support.
Supply Capacity: Ability to meet demand fluctuations, scalability for large or specialty orders.
Intellectual Property Status: Patent considerations for newer APIs like Durloactam Sodium.
Pricing and Lead Times: Competitive costs balanced with reliable delivery schedules.
Geopolitical and Logistical Factors: Proximity, export controls, and stability of supply chains.

Emerging Trends and Market Dynamics

The antibiotic API market demonstrates increasing reliance on Asian manufacturers, particularly Chinese and Indian companies, due to cost advantages and expanding manufacturing capacities. However, stricter regulatory scrutiny, especially by the EMA and USFDA, compels suppliers to elevate quality standards, often leading to partnerships with established global firms.

For innovative APIs like Durloactam Sodium, licensing agreements and collaborations with R&D-focused biotech firms are crucial. The ongoing expansion of antimicrobial research funding positively influences suppliers' capacity development.

Regulatory Landscape and Verification

Suppliers seeking to provide APIs for global markets must adhere to regulatory standards:

USFDA: Facility registration, Drug Master File (DMF) submissions.
EMA: GMP compliance, certification, and auditing.
WHO: Prequalification standards, especially for emerging markets.
Others: Local regulatory approvals, particularly in Latin America, Africa, and Southeast Asia.

It is essential for pharmaceutical companies to verify supplier documentation, conduct audit visits, or partner through trusted intermediaries.

Strategic Sourcing Recommendations

Given the specific attributes of Durloactam Sodium and Sulbactam Sodium, companies should:

Engage with multiple suppliers to mitigate supply risks.
Prioritize suppliers with proven regulatory track records.
Consider the potential for early engagement with manufacturers of Durloactam Sodium for assured supply once commercialized.
Regularly monitor geopolitical developments influencing Chinese and Indian supply chains.

Conclusion

The supply chain for Durloactam Sodium remains in developmental stages, with key collaborations and licensing routes shaping its commercial trajectory. Conversely, Sulbactam Sodium benefits from a mature, diversified supplier base spanning Asia and Europe. Moving forward, the pharmaceutical industry must navigate regulatory complexities, ensure quality compliance, and foster strategic partnerships to secure reliable supplies of these critical antibiotics.

Key Takeaways

Durloactam Sodium suppliers primarily include innovative CMOs and research entities in China, Europe, and North America, with commercial production expected to ramp up as regulatory approvals progress.
Sulbactam Sodium enjoys a broad, established supplier network, especially in China, India, and Europe, offering competitive quality and capacity.
Supplier evaluation should emphasize regulatory compliance, quality assurance, scalability, and geopolitical stability.
Emerging API markets are positioning around collaborations, licensing, and technological innovations to meet the growing demand for novel β-lactamase inhibitors.
Strategic sourcing necessitates diversification, early engagement, and continuous regulatory vigilance to mitigate supply risks.

FAQs

Who are the leading global suppliers of Sulbactam Sodium?
Major suppliers include Zhejiang Huazhong Pharmaceutical, Zhejiang Singclean Medical, Maple Pharmaceuticals, Vianex S.A., and FAES FARMA, all maintaining GMP standards and serving international markets.
Are there shortages anticipated for Durloactam Sodium?
Given its emerging status, supply may be limited initially. However, licensing agreements with research entities and expansion of manufacturing facilities are expected to address future demand.
What regulatory certifications should suppliers have?
Suppliers should possess GMP certification aligned with FDA, EMA, or WHO standards, alongside appropriate analytical and quality documentation.
Can I source these APIs from regional suppliers?
Yes. Chinese and Indian suppliers dominate the market; European and North American suppliers are also present, especially for high-demand markets requiring strict regulatory compliance.
What factors influence the choice between different suppliers?
Critical factors include compliance with regulatory standards, quality consistency, capacity, pricing, supply stability, and geopolitical considerations.

Sources:

[1] WHO Prequalification of Pharmaceuticals – Sulbactam Sodium API Overview.
[2] China National Pharmaceutical Industry Association – API manufacturing capabilities report.
[3] European Directorate for the Quality of Medicines & Healthcare (EDQM) product certification data.
[4] Pharmaceutical Technology Asia – Market insights on antibiotics API manufacturing trends.
[5] U.S. Food & Drug Administration – GMP compliance requirements for API suppliers.

Suppliers and packagers for generic pharmaceutical drug: DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM