Suppliers and packagers for CHEMET

CHEMET

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 CHEMET (Succimer)

CHEMET, the brand name for the chelating agent succimer (meso-2,3-dimercaptosuccinic acid), is critical in treating heavy metal poisoning, particularly lead toxicity. The drug’s supply chain involves a network of manufacturers, distributors, and regulatory frameworks that ensure quality and availability. This report examines the key suppliers, regulatory requirements, regional dynamics, and challenges in the CHEMET pharmaceutical market.

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Key Manufacturers of CHEMET API and Finished Dosage Forms

Major Global Pharmaceutical Companies

Recordati Rare Diseases is the primary U.S. supplier of CHEMET capsules, as evidenced by its role during the 2021 drug shortage[13]. The company manufactures the drug under strict Good Manufacturing Practices (GMP) and holds necessary certifications like the U.S. Drug Master File (USDMF)[14]. Sanofi and Lundbeck Inc. are also listed as manufacturers, with Sanofi contributing to both active pharmaceutical ingredient (API) production and finished formulations[8][5]. These companies operate GMP-compliant facilities, ensuring adherence to U.S. FDA and European Medicines Agency (EMA) standards[3][14].

API Production and Specialty Chemical Suppliers

American Chemet Corporation, though primarily a metal-based chemical manufacturer, indirectly supports pharmaceutical supply chains by producing precursors for APIs[2][6]. Meanwhile, Hefei Lifeon Pharmaceutical Co., Ltd. and Zhengzhou Jingjiang Chemical Co., Ltd. in China specialize in synthesizing succimer API, catering to global demand[15]. These suppliers emphasize cost-effectiveness but face scrutiny over compliance with international GMP standards[5].

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Regulatory Frameworks Governing CHEMET Suppliers

Drug Master Files (DMFs) and Certifications

A Chemet USDMF is mandatory for U.S. market entry, detailing the drug’s manufacturing process, quality controls, and stability data[3][14]. For example, Recordati’s USDMF includes specifications for succimer’s chemical properties and storage conditions[14]. The European Union requires a Certificate of Suitability (CEP), while Japan mandates a Japanese Drug Master File (JDMF)[5]. Non-compliance with these standards can result in market exclusion, as seen in the 2021 shortage when Recordati’s production delays disrupted supply[13].

Good Manufacturing Practices (GMP)

GMP certifications are non-negotiable for CHEMET suppliers. The FDA’s Current Good Manufacturing Practices (cGMP) require rigorous batch testing, documented in Certificates of Analysis (CoA)[3]. For instance, Chemet capsules must undergo purity assessments against pharmacopeial standards like the U.S. Pharmacopeia (USP) and European Pharmacopoeia (EP)[3][14]. Indian API suppliers, such as those listed on PharmaCompass, often highlight WHO-GMP compliance to access emerging markets[5][12].

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Regional Supplier Dynamics

U.S. and European Markets

The U.S. relies on Recordati Rare Diseases and Kremers Urban Pharmaceuticals (a Lannett Company subsidiary) for CHEMET capsules[14][17]. These companies dominate due to their USDMF holdings and established distribution networks. In Europe, Sanofi and Helsinn Advanced Synthesis leverage CEP certifications to supply succimer for clinical use[5][8]. The EU’s emphasis on environmental stewardship aligns with American Chemet’s sustainability initiatives, though their role remains peripheral to direct drug production[6][12].

Asian Suppliers and Emerging Economies

India’s Chemet Chemicals Pvt. Ltd. and Chemitron Group focus on API sourcing and distribution, acting as intermediaries between global manufacturers and regional markets[10][12]. However, their primary revenue stems from agrochemicals and industrial chemicals, with limited direct involvement in succimer production[9][10]. Chinese API manufacturers, such as Jinan Shengqi Pharmaceutical, capitalize on lower production costs but face regulatory hurdles in Western markets[15].

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Market Challenges and Supply Chain Vulnerabilities

Drug Shortages and Production Disruptions

The 2021 CHEMET shortage underscored the risks of relying on a single supplier[13]. Recordati’s production delays, attributed to raw material shortages, highlighted the need for diversified sourcing. Compounding pharmacies and alternative chelators like calcium disodium EDTA bridged the gap, but clinicians noted succimer’s superior oral bioavailability[13][17].

Pricing and Access Disparities

CHEMET’s cost varies significantly by region. In the U.S., a 100 mg capsule costs approximately $8.60, whereas Indian wholesalers like GNH India offer discounted rates through validated cold-chain shipments[16][17]. Despite this, low-income regions face access barriers due to inadequate regulatory infrastructure and counterfeit risks[15][16].

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Conclusion

The CHEMET supply chain is a complex interplay of multinational pharmaceutical companies, regional distributors, and stringent regulatory frameworks. While manufacturers like Recordati and Sanofi ensure quality, vulnerabilities persist due to monopolistic production and geopolitical factors. Future strategies should prioritize API diversification, enhanced GMP harmonization, and public-private partnerships to mitigate shortages. For healthcare providers, understanding supplier landscapes and regulatory nuances is essential to securing reliable access to this critical antidote.

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Key Takeaways

• Recordati Rare Diseases is the primary U.S. supplier of CHEMET, with Sanofi and Lundbeck contributing to global API production.
• USDMF and GMP certifications are critical for market entry, ensuring drug safety and efficacy.
• Supply chain vulnerabilities, exemplified by the 2021 shortage, necessitate diversified manufacturing and strategic stockpiling.

FAQs

1. Who manufactures CHEMET?
   Recordati Rare Diseases (U.S.), Sanofi (EU/Asia), and Lundbeck (global) are key manufacturers.

2. What regulatory approvals are required for CHEMET suppliers?
   USDMF (U.S.), CEP (EU), and JDMF (Japan), alongside GMP certifications.

3. How did the 2021 shortage impact CHEMET availability?
   Recordati’s production delay forced reliance on alternative chelators until supply resumed in June 2021[13].

4. What role do Indian companies play in the CHEMET supply chain?
   They act as distributors and API intermediaries but rarely produce the finished drug[9][12].

5. Why is CHEMET costly in the U.S.?
   Limited suppliers and stringent FDA compliance increase production costs, with capsules priced at ~$8.60 each[17].

“The 2021 CHEMET shortage revealed critical gaps in our pharmaceutical supply chains, emphasizing the need for redundancy in critical drug production.” — CDC Archive[13]

References

1. https://www.chemical-distributors.com/dir/profile.asp?CompanyID=112
2. https://www.chemet.com
3. https://www.pharmacompass.com/active-pharmaceutical-ingredients/chemet
4. https://www.cphi-online.com/chemet-comp245812.html
5. https://www.pharmacompass.com/manufacturers-suppliers-exporters/chemet
6. https://directory.marinelink.com/companies/company/american-chemet-210190
7. https://www.chemet.com/history
8. https://go.drugbank.com/drugs/DB00566
9. https://chemetindia.com/about
10. https://www.tradeindia.com/products/methyl-parathion-1592142.html
11. https://www.drugs.com/imprints/100-chemet-2202.html
12. https://pluschem.com/about-us/our-members/
13. https://archive.cdc.gov/www_cdc_gov/nceh/lead/news/succimer-drug-shortage.html
14. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019998s021lbl.pdf
15. https://www.chemicalbook.com/ChemicalProductProperty_EN_CB9142563.htm
16. https://www.gnhindia.com/products/us-ndc/succimer-chemet-55292-201/
17. https://www.empr.com/drug/chemet/