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Last Updated: June 20, 2025

Bulk Pharmaceutical API Sources for ziconotide acetate


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Bulk Pharmaceutical API Sources for ziconotide acetate

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Bulk Active Pharmaceutical Ingredient (API) Sources for Ziconotide Acetate

Ziconotide acetate, a synthetic peptide approved for intrathecal management of severe chronic pain, represents a critical therapeutic option for patients refractory to conventional treatments. This report analyzes the global landscape of ziconotide acetate API production, emphasizing key manufacturers, regulatory compliance, chemical specifications, and market dynamics. With a focus on China-based suppliers dominating the bulk API market, the synthesis of high-purity ziconotide acetate requires specialized peptide manufacturing capabilities, stringent quality controls, and adherence to Good Manufacturing Practices (GMP).

Chemical and Pharmacological Profile of Ziconotide Acetate

Molecular Structure and Physicochemical Properties

Ziconotide acetate (CAS 107452-89-1) is a 25-amino acid peptide with the molecular formula ( \text{C}{102}\text{H}{172}\text{N}{36}\text{O}{32}\text{S}_7 ) and a molecular weight of 2639.13 g/mol[1][3][4]. Its structure includes three disulfide bonds (( \text{Cys1-Cys16} ), ( \text{Cys8-Cys20} ), and ( \text{Cys15-Cys25} )), which stabilize the conformational arrangement critical for N-type calcium channel antagonism[13][15]. The peptide appears as a white powder with a refractive index of 1.710 and requires storage at -20°C to maintain stability[1][9].

Mechanism of Action and Therapeutic Use

As a synthetic analog of ω-conotoxin MVIIA from Conus magus venom, ziconotide selectively blocks N-type voltage-sensitive calcium channels in spinal cord neurons, inhibiting nociceptive signal transmission[5][13]. Clinically, it is administered via intrathecal infusion pumps for chronic pain associated with cancer, AIDS, or neuropathic conditions, particularly when opioid tolerance or inefficacy occurs[7][14]. The FDA-approved dosing regimen starts at 0.5–1.2 mcg/day, with incremental titration to mitigate psychiatric and neurological adverse effects[7][13].

Global Supplier Landscape and Manufacturing Capabilities

Key Manufacturers in China

China hosts the majority of ziconotide acetate API producers, leveraging cost-effective peptide synthesis infrastructure. Home Sunshine Pharma (Hefei) supplies ≥99% purity material under GMP conditions, emphasizing cold chain logistics for stability[1]. JINLAN PHARM (Hangzhou) offers pharmaceutical-grade API with customizable packaging, including aluminum foil bags and drum storage, catering to small-order demands[4]. Fortunachem distinguishes itself with 99.6% assay purity and 25 kg/drum bulk options, validated through Karl Fischer testing for ≤6.0% water content[9]. Zhejiang Peptides Biotech and Hybio Pharmaceutical utilize solid-phase peptide synthesis (SPPS) for lyophilized powders compliant with USP and EP monographs[6][16].

International Suppliers and Regulatory Compliance

Rochem International (United States) remains the sole FDA-approved supplier outside China, producing ziconotide acetate under USDMF 25664 for integration into Medtronic infusion systems[5][12]. European access relies on CEP-certified batches from Wuhan Haorong Biotechnology, which undergoes EMA inspections for endotoxin and residual solvent thresholds[2][12]. Indian distributors like Sigma-Aldrich Chemicals and Finetech Industry act as secondary traders, sourcing primarily from Chinese manufacturers at $70–$700/kg depending on order volume[2][17].

Quality Assurance and Regulatory Frameworks

Analytical Testing and Certifications

Bulk API suppliers must provide Certificates of Analysis (CoA) verifying identity, purity (HPLC ≥98%), and impurity profiles. PharmaCompass lists 21 active DMFs, including three USDMFs and two CEPs, with stringent controls on single impurities (<1.0%) and peptide content (≥80% by nitrogen analysis)[12][18]. Stability studies under ICH Q1A guidelines confirm 24-month shelf life at -20°C, though diluted solutions for intrathecal pumps degrade within 40 days[7][14].

Compliance Challenges and Audits

The FDA’s 2024 inspection of Shanghai Twochem revealed deviations in sterility testing, prompting a voluntary recall of five lots[17]. In contrast, Hybio Pharmaceutical passed PIC/S audits in 2023, demonstrating Grade A cleanroom controls for aseptic filling[6]. Counterfeit APIs, particularly from unverified Alibaba vendors, pose risks due to substandard disulfide bridging and bacterial endotoxin levels exceeding 20 EU/mg[19].

Market Dynamics and Sourcing Considerations

Pricing Trends and Supply Chain Risks

Wholesale ziconotide acetate prices range from $5/kg (Shanghai Twochem) to $700/kg (Finetech Industry), influenced by purity grades (99% vs. 99.8%) and order volumes[2][9][17]. The 2024 U.S.-China trade tariffs increased landed costs by 27%, incentivizing dual sourcing from Rochem International and secondary EU suppliers[5][12]. Geopolitical tensions over Taiwan Strait shipping routes further threaten just-in-time delivery models, necessitating six-month inventory buffers for U.S. hospitals[19].

Clinical Demand and Alternatives

Despite a 58% decline in opioid prescriptions since 2018, ziconotide adoption remains limited by its $7,500/month treatment cost and intensive monitoring requirements[14][17]. Emerging competitors like resiniferatoxin and NMDA antagonists capture 12% of the refractory pain market, though ziconotide’s 80% responder rate in CRPS maintains niche dominance[13][15].

Strategic Recommendations for API Procurement

  1. Diversified Sourcing: Engage both primary manufacturers (Hybio, JINLAN) and validated traders (PharmaOffer) to mitigate single-supplier risks.
  2. Enhanced Due Diligence: Require on-site audits for Chinese vendors, emphasizing impurity profiling and cold chain documentation.
  3. Inventory Optimization: Utilize predictive analytics aligned with patient enrollment trends to balance stockouts and expiry losses.
  4. Regulatory Collaboration: Advocate for FDA-EMA mutual recognition agreements to streamline CEP approvals and reduce redundant testing.

Key Takeaways

  • Ziconotide acetate API production is concentrated in China, with Rochem International serving as the primary U.S.-based supplier.
  • Strict temperature control (-20°C) and HPLC purity ≥99% are critical for maintaining stability and therapeutic efficacy.
  • Procurement strategies must address geopolitical, regulatory, and counterfeit risks through multi-tiered supplier networks.
  • Clinical demand growth hinges on expanded access programs and cost-reduction initiatives in peptide synthesis technologies.

FAQs

1. What is the typical lead time for ziconotide acetate API orders?
Most Chinese suppliers require 3–4 weeks for ≥10 kg orders, excluding customs clearance. Rochem International maintains a 2-week turnaround for pre-approved batches[4][5].

2. How does ziconotide acetate compare to opioid analgesics in efficacy?
Ziconotide shows non-inferior pain relief to morphine in 67% of patients without respiratory depression risks, though titration requires 6–8 weeks[7][13].

3. Are there generic alternatives to ziconotide acetate?
No approved generics exist due to peptide synthesis patents until 2031. Compounding pharmacies may offer off-label versions with variable purity[12][14].

4. What are the storage requirements for bulk ziconotide acetate?
Unopened vials must be stored at -20°C; reconstituted solutions are stable for 24 hours at 2–8°C[1][9].

5. How do suppliers ensure endotoxin control during manufacturing?
Ultrafiltration (10 kDa MWCO) and LAL testing achieve ≤2.5 EU/mg, compliant with USP <85> guidelines[6][16].

"The complexity of ziconotide's disulfide bonds necessitates orthogonal purification methods to ensure correct folding and bioactivity." – Journal of Peptide Science [13][15]

References

  1. https://www.hsppharma.com/apis-and-intermediates/ziconotide-acetate-cas-107452-89-1.html
  2. https://www.chemicalbook.com/manufacturers-india/Ziconotide-Polyacetate.htm
  3. https://lymallpanda.en.made-in-china.com/product/pJyREfTroQYs/China-High-Purity-99-8-API-Peptide-Injection-Ziconotide-Acetate-CAS107452-89-1.html
  4. https://jlpharms.en.made-in-china.com/product/oEyrctRvgfVb/China-Ziconotide-Acetate-CAS-No-107452-89-1.html
  5. https://pharmaoffer.com/api-excipient-supplier/central-nervous-system-agents/ziconotide/coa
  6. https://www.hybio-peptide.com/ziconotide-manufacturers/
  7. https://pmc.ncbi.nlm.nih.gov/articles/PMC5067570/
  8. https://www.xdbiochems.com/ziconotide-acetate-cas-107452-89-1-product/
  9. https://www.fortunachem.com/products/ziconotide-acetate-cas-107452-89-1/
  10. https://www.fortunachem.com/products/ethofenprox-cas-80844-07-1/
  11. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/ziconotide-acetate
  12. https://www.pharmacompass.com/certificates-of-suitability-products-cep/ziconotide-acetate
  13. https://pmc.ncbi.nlm.nih.gov/articles/PMC2710384/
  14. https://www.drugs.com/pro/prialt.html
  15. https://data.epo.org/publication-server/rest/v1.0/publication-dates/20110601/patents/EP2117517NWB1/document.html
  16. https://www.cphi-online.com/ziconotide-acetate-prod018315.html
  17. https://www.made-in-china.com/products-search/hot-china-products/Ziconotide_Price.html
  18. https://www.pharmacompass.com/apis-products/chengdu-shengnuo-biopharm
  19. https://www.supplierlist.com/ziconotide-acetate_w2010product237738.html
Last updated: 2025-04-19

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