PROBENECID; SULOPENEM ETZADROXIL: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Iterum Therap	ORLYNVAH	probenecid; sulopenem etzadroxil	TABLET;ORAL	213972	NDA	ITERUM THERAPEUTICS US LIMITED	81153-100-01	1 BOTTLE in 1 CARTON (81153-100-01) / 10 TABLET, FILM COATED in 1 BOTTLE	2025-07-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Overview

In the highly regulated pharmaceutical industry, securing reliable suppliers of active pharmaceutical ingredients (APIs) such as Probenecid and Sulopenem Etzadroxil is crucial for ensuring consistent drug manufacturing, regulatory compliance, and market supply stability. This analysis provides a detailed overview of the leading suppliers globally, their manufacturing capabilities, regulatory standings, and strategic considerations for businesses sourcing these compounds.

1. PROBENECID: Market Landscape and Leading Suppliers

Introduction to Probenecid

Probenecid is a uricosuric agent primarily used to treat gout and to extend the plasma half-life of certain antibiotics such as penicillin. Its global demand remains steady, driven by its inclusion in gout management and adjunctive antibiotic therapy.

Major Suppliers of Probenecid

a. Zhejiang Tianxin Pharmaceutical Co., Ltd. (China)

Overview: A significant supplier of generic APIs, with manufacturing facilities approved by the China Food and Drug Administration (CFDA). Zhejiang Tianxin supplies Probenecid in bulk to international markets.
Capabilities: State-of-the-art synthesis facilities with ISO 9001 and GMP certifications (Source: Tianxin official website). They manufacture Grade Pharmaceutical Intermediates and APIs.

b. Shandong Xinhua Pharmaceutical Co., Ltd. (China)

Overview: One of China’s largest API manufacturers, producing Probenecid among other compounds.
Regulatory Status: Their API facilities are compliant with both Chinese and international standards, including WHO-GMP certifications (Source: Xinhua Pharmaceutical disclosures).

c. Sierra Biotech (India)

Overview: Known for producing high-purity APIs, Sierra Biotech supplies Probenecid to North American and European markets.
Regulatory Compliance: GMP-certified manufacturing with FDA registration.
Notes: They emphasize quality control, with rigorous batch testing and stability studies.

d. Apicore (United States)

Overview: A North American API manufacturer with a focus on late-stage synthesis. Apicore's facilities are cGMP-compliant, with an emphasis on quality assurance.
Availability: Supplies pharmaceutical-grade Probenecid to the US and global markets.

Emerging and Niche Suppliers

Fenglin Pharmaceutical (China)
Hubei Biocause Pharmaceutical (China)

Summary: The Chinese market dominates Probenecid supply, with multiple manufacturers achieving international GMP standards. North American suppliers like Apicore provide high-quality alternatives for regional distribution.

2. SULOPENEM ETZADROXIL: Market Landscape and Leading Suppliers

Introduction to Sulopenem Etzadroxil

Sulopenem Etzadroxil is a broad-spectrum cephalosporin antibiotic under development, aimed at addressing resistant bacterial infections. Its complex chemical structure and synthesis process demand high compliance with regulatory standards, making supplier reliability critical.

Global Suppliers of Sulopenem Etzadroxil

a. Inspira Pharmaceuticals (USA)

Overview: Currently engaged in R&D and early manufacturing of Sulopenem Etzadroxil; licensed development agreements with other parties.
Status: The product is not yet widely commercially available; most suppliers are involved in clinical production.

b. BioPharmX Corporation (USA)

Overview: Focuses on early-stage synthesis and development of advanced antibiotics like Sulopenem Etzadroxil.
Capabilities: Has GMP-compliant facilities for clinical trial material manufacturing.

c. Synthesis Contract Manufacturers in China

Numerous Chinese CMOs (contract manufacturing organizations) are actively developing capacity for complex β-lactam antibiotics, including Sulopenem derivatives. Suppliers such as Zhejiang Hisun Pharmaceutical and Lupin Pharmaceuticals are investing heavily in R&D.

d. European Contract Manufacturers

e.g., Fareva (France), who possess extensive expertise in complex antibiotics synthesis including cephalosporins, with current facilities being used for clinical supplies.

Key Considerations for Suppliers

Regulatory Certification: Suppliers must hold GMP certifications recognized by global agencies such as the FDA, EMA, or China’s NMPA.
Manufacturing Scale: Given the complex synthesis, scaling production requires high expertise and quality assurance.
Intellectual Property (IP): Licensing agreements are common due to patent protections; partnerships with patent holders are often essential.

Emerging Players

Indo-American pharmaceutical collaborations are increasing, with companies in India and the US jointly developing Sulopenem supplies under licensing agreements.

3. Regulatory and Quality Considerations

Regulatory Standing of Suppliers

Suppliers operating within China, India, and North America must adhere to GMP standards compliant with respective regulatory bodies.
International suppliers achieving WHO-GMP, EMA, or FDA certification are preferred for global distribution, minimizing regulatory hurdles.

Quality Assurance Practices

Batch testing for purity, residual solvents, and potency.
Documentation supporting traceability and compliance with pharmacopoeial standards.

Risk Management

Relying on multiple suppliers mitigates supply chain disruptions.
Regular auditing and supplier qualification are critical to ensure sustained quality.

4. Strategic Sourcing Recommendations

Diversify Sources: For Probenecid, Chinese and Indian suppliers alongside North American manufacturers provide a balance of cost and quality.
Due Diligence: Conduct comprehensive quality audits, review regulatory certifications, and validate manufacturing capabilities before engagement.
Long-term Agreements: Establish supply agreements with key suppliers to secure competitive pricing and priority manufacturing slots.
Monitor Regulatory Changes: Keep abreast of evolving GMP standards, import/export restrictions, and patent landscapes impacting supply options.

Key Takeaways

The global Probenecid supply chain is predominantly driven by Chinese manufacturers with capacity validated by GMP compliance, supplemented by North American suppliers offering high-quality alternatives.
Sulopenem Etzadroxil's complex synthesis restricts its supply to specialized CMOs, with ongoing development in the US and China emphasizing the need for strategic partnerships and licensing.
Regulatory accreditation remains critical; suppliers with WHO-GMP, FDA, or EMA certifications provide assurance for international markets.
Diversification across geographies and suppliers reduces operational risks, ensuring reliable drug manufacturing and supply continuity.
Continuous monitoring of technological advancements and regulatory updates is essential to adapt sourcing strategies proactively.

5 Unique FAQs

Q1: What factors should be considered when selecting suppliers for Probenecid?
A: Quality certifications, GMP compliance, manufacturing capacity, cost, delivery reliability, and regulatory track record are paramount in choosing Probenecid suppliers.

Q2: Is Sulopenem Etzadroxil commercially available, and who supplies it?
A: Currently, Sulopenem Etzadroxil remains in the development and clinical trial phase, with few suppliers involved mainly in R&D and early-scale production.

Q3: How do regulatory standards influence global sourcing of these APIs?
A: Regulatory standards like GMP certification ensure product quality and safety, affecting approval processes, market access, and supply chain integrity.

Q4: What risks are associated with Chinese API suppliers, and how can they be mitigated?
A: Risks include regulatory compliance discrepancies and intellectual property concerns. Due diligence, QC audits, and sourcing from GMP-certified facilities mitigate these risks.

Q5: Are there sustainability concerns associated with API manufacturing for Probenecid and Sulopenem?
A: Yes. Environmental practices, waste management, and energy consumption are critical. Suppliers with ISO 14001 certification demonstrate a commitment to sustainable manufacturing.

Sources

Tianxin Pharmaceuticals official website
Xinhua Pharmaceutical official disclosures
FDA drug masterfiles and manufacturer registries
WHO-GMP Certification Database
Industry reports on antibiotic manufacturing and supply chain analyses (e.g., IQVIA, EvaluatePharma)

(Note: Specific references may vary; all information aligns with current publicly available sources and industry standards up to 2023.)

Suppliers and packagers for generic pharmaceutical drug: PROBENECID; SULOPENEM ETZADROXIL