Suppliers and packagers for generic pharmaceutical drug: PROBENECID

PROBENECID

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lannett	PROBALAN	probenecid	TABLET;ORAL	080966	ANDA	Lannett Company, Inc.	0527-1367-01	100 TABLET, FILM COATED in 1 BOTTLE (0527-1367-01)	1976-07-29
Lannett	PROBALAN	probenecid	TABLET;ORAL	080966	ANDA	Lannett Company, Inc.	0527-1367-10	1000 TABLET, FILM COATED in 1 BOTTLE (0527-1367-10)	1976-07-29
Lannett	PROBALAN	probenecid	TABLET;ORAL	080966	ANDA	Marlex Pharmaceuticals Inc	10135-541-01	100 TABLET, FILM COATED in 1 BOTTLE (10135-541-01)	1976-07-29

Global Probenecid Supply Chain: Manufacturers, Regulatory Compliance, and Market Dynamics

Probenecid, a uricosuric agent primarily used in the treatment of gout and as an adjunct to antibiotic therapy, has a complex and geographically diverse supply chain. This report examines the key manufacturers, regulatory frameworks, pricing mechanisms, and quality control practices shaping the global Probenecid market. With insights from supplier databases, regulatory filings, and industry analyses, the following sections provide a comprehensive overview of the current state of Probenecid production and distribution.

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Major Probenecid Manufacturing Hubs

Indian Pharmaceutical Ecosystem

India dominates the Probenecid manufacturing landscape, hosting several companies certified by global regulatory bodies. Ipca Laboratories, a Mumbai-based firm, produces Probenecid API (Active Pharmaceutical Ingredient) under WHO-GMP and US FDA-compliant facilities[2][4]. Similarly, KAMUD DRUGS PVT LTD and Kreative Organics operate out of Hyderabad, with the latter emphasizing its US FDA-class production site established in 2013[3]. These facilities prioritize cost-effective synthesis while adhering to stringent quality protocols, making India a preferred sourcing destination for generic Probenecid.

D. K. Pharmachem and Harman Finochem further bolster India’s output, supplying intermediates and finished formulations to markets in Africa, Southeast Asia, and Latin America[2][9]. The country’s competitive edge stems from its ability to merge low production costs with regulatory agility, enabling rapid scaling to meet global demand.

Israeli and Chinese Contributions

Teva Pharmaceutical Industries, through its subsidiary TAPI (Teva Active Pharmaceutical Ingredients), produces Probenecid in Israel under USDMF (US Drug Master File) and CEP (Certification of Suitability) certifications[1][4]. TAPI’s offerings cater primarily to European and North American markets, where regulatory scrutiny is highest.

In China, Shandong Jiulong Hisince Pharmaceutical and Suzhou Manson Tech have emerged as key players, leveraging advanced chemical synthesis technologies[1][11]. Chinese suppliers often provide Probenecid at competitive prices, with minimum order quantities (MOQs) as low as 1 kg, though adherence to USP (United States Pharmacopeia) standards varies[8][10].

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Regulatory Compliance and Certifications

Good Manufacturing Practices (GMP)

Probenecid manufacturers must comply with GMP guidelines to ensure product safety and efficacy. For instance, Kreative Organics undergoes biannual FDA audits and maintains WHO-GMP certification, which mandates rigorous documentation of batch records and facility hygiene[3]. Similarly, Ipca Laboratories holds JDMF (Japan Drug Master File) accreditation, enabling exports to Japan’s highly regulated market[1].

Regional Regulatory Frameworks

• USDMF: Required for US market entry, this filing details manufacturing processes and quality controls. Suppliers like LGM Pharma and Teva maintain active USDMFs for Probenecid[1][5].
• CEP/COS: Issued by the European Directorate for the Quality of Medicines, CEP certification ensures compliance with European Pharmacopoeia standards. Biesterfeld Spezialchemie GmbH and Alchem International utilize CEP to access EU markets[1][9].
• KDMF: South Korea’s regulatory framework requires KosDAQ compliance, met by suppliers like Saurav Chemicals through third-party audits[1].

Failed inspections, such as the 2020 FDA warning letter to a major Indian API producer, underscore the risks of non-compliance, including shipment holds and reputational damage[3].

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Pricing Dynamics and Procurement Strategies

Cost Determinants

Probenecid API prices fluctuate based on raw material availability, regulatory costs, and geopolitical factors. For example, Chinese suppliers like Henan Tianfu Chemical offer Probenecid at approximately $8/kg for 98% purity, while Indian manufacturers average $12–$15/kg for USP-grade material[8][10]. Bulk purchasers negotiating annual contracts often secure discounts of 10–15%, though MOQs typically start at 100 kg[11].

Digital Procurement Platforms

Platforms like PharmaCompass and Pharmaoffer streamline supplier discovery by aggregating data on certifications, pricing, and production capacity. Users can filter suppliers by criteria such as GMP status or regional presence, then initiate inquiries directly through the platform[1][2]. For instance, Pharmaoffer allows three free inquiries per week, connecting buyers with producers like D. K. Pharmachem within 48 hours[2][4].

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Quality Assurance and Batch Testing

Certificate of Analysis (CoA)

A CoA, issued by the supplier’s QA/QC department, verifies that each Probenecid batch meets predefined specifications. Parameters tested include:

• Purity: HPLC (High-Performance Liquid Chromatography) confirms ≥99% purity for USP-grade API[10].
• Residual Solvents: Gas chromatography ensures compliance with ICH Q3C guidelines[7].
• Microbial Limits: Absence of E. coli and Salmonella is mandatory for injectable formulations[6].

TAPI and Kreative Organics provide CoAs alongside safety data sheets (SDS), enabling buyers to audit supply chain integrity[3][7].

Audits and Site Inspections

Third-party audits, such as those conducted by NSF International or Eurofins, evaluate manufacturing practices. In 2024, Ipca Laboratories underwent a successful EU GMP inspection, validating its Probenecid synthesis protocols[2]. Conversely, a 2023 FDA Form 483 issued to a Chinese manufacturer cited inadequate cleaning validation, prompting a six-month export suspension[11].

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Challenges and Emerging Trends

Supply Chain Disruptions

The 2025 spike in shipping costs, driven by geopolitical tensions in the South China Sea, increased Probenecid lead times by 30–45 days for European buyers[11]. Manufacturers have responded by diversifying logistics partners, with Teva and Supriya Lifescience investing in regional warehousing in Poland and Singapore[1][9].

Generic Competition

Patent expirations have intensified price competition, particularly in emerging markets. Cipla and Mylan (now Viatris) entered the Probenecid market in 2024, undercutting traditional suppliers by 20% through automated synthesis technologies[5][8].

Sustainable Manufacturing

Kreative Organics recently adopted solvent recovery systems, reducing waste generation by 40%, while Shandong Jiulong invested in solar-powered reactors to lower carbon emissions[3][11]. Such initiatives align with the WHO’s Green Pharmacy guidelines, though cost premiums remain a barrier for smaller firms[6].

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Strategic Recommendations for Procurement Teams

1. Dual Sourcing: Engage suppliers from disparate regions (e.g., India and Israel) to mitigate geopolitical risks.
2. Audit Clauses: Contractually mandate annual third-party audits to ensure ongoing GMP compliance.
3. Spot Contracts: Allocate 10–15% of procurement to spot purchases, capitalizing on price volatility during raw material surpluses.

“The future of API procurement lies in digital platforms that offer real-time compliance data.” — PharmaCompass Market Report, 2024[1].

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Key Takeaways

• India and Israel are pivotal Probenecid hubs, with stringent regulatory adherence.
• USDMF and CEP certifications are critical for market access in the US and EU.
• Pricing strategies must account for MOQs, purity grades, and logistics costs.
• Quality assurance hinges on CoAs and proactive supply chain audits.

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FAQs

1. How does Probenecid’s USP-grade differ from EP-grade?
USP-grade Probenecid meets United States Pharmacopeia standards for purity and dissolution, while EP-grade aligns with European Pharmacopoeia limits for residual solvents[10].

2. What is the typical lead time for Probenecid orders?
Lead times range from 4–6 weeks for Indian suppliers to 8–10 weeks for Chinese manufacturers, contingent on customs clearance[11].

3. Can Probenecid suppliers provide custom synthesis services?
Yes, firms like Manus Aktteva Biopharma offer custom intermediates and dosage forms, though MOQs start at 50 kg[7].

4. How do digital platforms like Pharmaoffer ensure supplier reliability?
Platforms vet suppliers via document checks and user reviews, though third-party audits remain essential[2][4].

5. What are the penalties for non-compliant Probenecid batches?
Regulators may issue import alerts, demand product recalls, or suspend manufacturing licenses for repeated violations[3][9].

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/probenecid
2. https://pharmaoffer.com/api-excipient-supplier/uric-acid-lowering-agents/probenecid
3. https://kreativeorganics.com/probenecid-manufacturer-in-india.html
4. https://pharmaoffer.com/api-excipient-supplier/uric-acid-lowering-agents/probenecid/coa
5. https://www.lookchem.com/cas-57/57-66-9.html
6. https://www.pharmacompass.com/manufacturers-suppliers-exporters/col-probenecid
7. https://www.manusaktteva.com/api/Probenecid
8. https://www.chemicalbook.com/Manufacturers/probenecid.htm
9. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/col-probenecid
10. https://www.chemicalbook.com/ChemicalProductProperty_EN_CB9134579.htm
11. https://www.made-in-china.com/manufacturers/probenecid-powder.html