Suppliers and packagers for generic pharmaceutical drug: SUCCIMER

SUCCIMER

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Recordati Rare	CHEMET	succimer	CAPSULE;ORAL	019998	NDA	Recordati Rare Diseases, Inc.	55292-201-11	100 CAPSULE in 1 BOTTLE (55292-201-11)	2013-08-21

Suppliers for the Pharmaceutical Drug Succimer: A Comprehensive Analysis

Succimer, chemically known as meso-2,3-dimercaptosuccinic acid (DMSA), is a critical pharmaceutical agent used as a heavy metal chelator to treat lead and mercury poisoning. Its production and supply involve a complex network of manufacturers, distributors, and regulatory frameworks. This report provides an in-depth examination of Succimer’s global suppliers, regulatory landscape, market dynamics, and challenges in procurement.

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Global Supplier Landscape of Succimer

The supply chain for Succimer spans multiple continents, with a concentration of active pharmaceutical ingredient (API) manufacturers in Asia, particularly China. Key players include Hefei Lifeon Pharmaceutical Co., Ltd., Xi'an Lyphar Biotech Co., Ltd., and Shandong Octagon Chemicals Limited[2][3][9]. These companies specialize in producing Succimer API with certifications such as Good Manufacturing Practices (GMP), U.S. Drug Master Files (USDMF), and compliance with European Pharmacopoeia (EP) or United States Pharmacopeia (USP) standards[7][12].

In North America, Recordati Rare Diseases holds the brand name Chemet (succimer capsules), which remains the sole FDA-approved formulation as of April 2025[4][6]. While generic versions are unavailable in the U.S., distributors like GNH India facilitate global access to Chemet through validated cold-chain logistics[6]. European suppliers, including Cilag AG and Piramal Pharma Solutions, contribute to the API market with adherence to stringent regulatory requirements like the Certificate of Suitability (CEP)[2][7].

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Regulatory and Certification Requirements

Good Manufacturing Practices (GMP) dominate the production standards for Succimer API. Manufacturers must adhere to region-specific guidelines, such as the U.S. Food and Drug Administration’s (FDA) cGMP and the European Medicines Agency’s (EMA) EU GMP[7][12]. For instance, Hefei Lifeon Pharmaceutical highlights its GMP-certified facilities, ensuring batch consistency and quality control[3][8]. Regulatory filings like USDMFs and Joint Drug Master Files (JDMF) protect intellectual property while enabling global market access[2][7].

Pharmacopeial standards further dictate quality benchmarks. Suppliers like Fengchen Group comply with BP (British Pharmacopoeia), EP, and USP monographs, which specify purity levels (e.g., ≥99%) and testing protocols[12]. Certificates of Analysis (CoA) provided by manufacturers validate each batch’s compliance, detailing parameters such as heavy metal residues and solubility[7][9].

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Pricing and Market Dynamics

Succimer API prices exhibit variability influenced by production scale, purity, and geopolitical factors. As of April 2025, quotations range from $1.10/g for high-purity batches (99% min) from Shaanxi Dideu Medichem to $10.00/kg for bulk orders from Hebei Chuanghai Biotechnology[10]. Finished formulations like Chemet command higher costs due to patent exclusivity and distribution logistics[4][6].

The absence of generic alternatives in the U.S. market underscores Recordati’s market dominance, though API suppliers strategically position themselves for potential patent expirations[4][7]. Platforms like PharmaCompass and Alibaba streamline supplier discovery, enabling buyers to compare prices, certifications, and regional availability[2][3][9].

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Challenges in Procurement and Quality Assurance

Procuring Succimer involves navigating fragmented regulatory landscapes and ensuring supply chain transparency. Buyers must verify supplier credentials, as fraudulent APIs pose significant risks[4][7]. For example, PharmaOffer and ChemicalBook provide audit reports and CoAs to mitigate quality concerns[9][10]. Cold-chain logistics, emphasized by distributors like GNH India, are critical for maintaining API stability during transit[6].

Regional disparities in regulatory enforcement also pose challenges. While Chinese suppliers dominate API production, concerns over data integrity and inspections persist[3][8]. Conversely, European and U.S. manufacturers face higher production costs but offer robust regulatory track records[2][7].

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Future Outlook and Strategic Considerations

The Succimer market is poised for evolution as patent cliffs and emerging markets drive competition. Strategic partnerships with API manufacturers, such as Shandong Octagon Chemicals, could reduce costs for generic entrants post-2025[9][10]. Advances in chelation therapy and expanded indications for heavy metal detoxification may further stimulate demand.

Buyers are advised to prioritize suppliers with multi-regional certifications (e.g., USDMF, CEP) and invest in long-term quality agreements. Platforms facilitating direct supplier engagement, such as PharmaCompass, will remain pivotal in navigating this dynamic landscape[2][7][9].

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Key Takeaways

• Succimer’s global supply chain relies heavily on Chinese API manufacturers, supplemented by branded distributors in the U.S. and Europe.
• Regulatory compliance (GMP, USDMF, pharmacopeial standards) is non-negotiable for ensuring product quality.
• Price variability and patent exclusivity shape procurement strategies, with platforms like PharmaCompass aiding supplier selection.
• Future market shifts will hinge on patent expirations, generic entry, and advancements in chelation therapy.

FAQs

1. Is a generic version of Succimer available in the U.S.?
   No, Chemet (by Recordati) remains the only FDA-approved formulation as of 2025[4].

2. What certifications should buyers prioritize when selecting a Succimer supplier?
   GMP, USDMF, and compliance with EP/USP standards are critical[7][12].

3. How do Succimer API prices vary?
   Prices range from $1.10/g to $10.00/kg, depending on purity and order volume[10].

4. Which regions dominate Succimer API production?
   China leads in API manufacturing, with key players like Hefei Lifeon Pharmaceutical[3][8].

5. What logistical considerations are essential for Succimer distribution?
   Cold-chain shipping and validated packaging are crucial for maintaining stability[6].

"The Succimer market exemplifies the interplay between regulatory rigor and global supply chain agility." – PharmaCompass Analysis[2][7].

References

1. https://www.adooq.com/succimer.html
2. https://www.pharmacompass.com/manufacturers-suppliers-exporters/succimer
3. https://www.alibaba.com/dmsa-suppliers.html
4. https://www.drugs.com/availability/generic-chemet.html
5. https://www.pharmacompass.com/ndc-api/sanofi-brand-of-succimer
6. https://www.gnhindia.com/products/us-ndc/succimer-chemet-55292-201/
7. https://www.pharmacompass.com/active-pharmaceutical-ingredients/succimer
8. https://www.buyersguidechem.com/chemical_supplier/DMSA_(Meso-2,3-dimercaptosuccinic_acid)
9. https://pharmaoffer.com/api-excipient-supplier/succimer
10. https://www.chemicalbook.com/ChemicalProductProperty_EN_CB9142563.htm
11. https://www.chemical-distributors.com/dir/profile.asp?CompanyID=112
12. https://www.fengchengroup.com/pharmaceutical-api/intermediates/succimer-dimercaptosuccinic-acid-dmsa-bp-ep.html