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Last Updated: July 28, 2025

Bulk Pharmaceutical API Sources for BUPIVACAINE HYDROCHLORIDE


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Bulk Pharmaceutical API Sources for BUPIVACAINE HYDROCHLORIDE

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Bulk Active Pharmaceutical Ingredient (API) Sources for Bupivacaine Hydrochloride: A Comprehensive Analysis

Last updated: July 27, 2025

Bupivacaine hydrochloride, a potent local anesthetic belonging to the amide group, has seen sustained demand due to its widespread use in regional anesthesia, epidural blocks, and post-operative pain management[3][6]. The global market for bupivacaine hydrochloride API is served by a diverse network of manufacturers and suppliers, primarily concentrated in India, China, and Europe, with stringent regulatory oversight ensuring quality compliance[1][4][7]. This report examines the pharmaceutical supply chain dynamics, regulatory frameworks, pricing mechanisms, and emerging trends shaping the bulk API market for this critical therapeutic agent.


Global Manufacturing Landscape of Bupivacaine Hydrochloride API

Regional Concentration of Production Facilities

India dominates the bupivacaine hydrochloride API market, with companies like Cerata Pharmaceuticals LLP and Jatan Exports operating WHO-GMP-certified facilities capable of producing IP/BP/USP-grade material[4][5][7]. Cerata Pharmaceuticals, for instance, supplies APIs to over 90 countries and maintains ready stock of bupivacaine base powder priced at ₹19,000/kg (approximately $228/kg), packaged in HDPE drums with double plastic liners[5]. Chinese manufacturers, including Xi’an Libang Enterprises and Shandong Chenghui Shuangda Pharmaceutical, complement this supply chain, offering competitive pricing at 14700 INR/kg ($176/kg) with a minimum order quantity of 1,000 kg[3][9]. European producers like Duchefa Farma B.V. in Switzerland cater to premium markets, providing GMP-certified API with a minimum order quantity of 1 kg, though at higher price points[8][9].

Regulatory Compliance and Certification Standards

API manufacturers must adhere to multifaceted regulatory requirements. The U.S. Food and Drug Administration (FDA) mandates USDMF submissions for market entry, while the European Directorate for the Quality of Medicines (EDQM) requires CEP certifications[1][7]. Indian suppliers like Jatan Exports highlight DMF filings and Written Confirmations to facilitate exports to regulated markets[7]. Spectrum Chemical’s USP-grade bupivacaine hydrochloride monohydrate, priced at $119.60 per unit, exemplifies compliance with 21 CFR Part 211 regulations for current Good Manufacturing Practices (cGMP)[6][11]. Third-party audits and ISO 9001 certifications further ensure batch-to-batch consistency, particularly for critical parameters such as purity (>99%) and solubility profiles[3][10].


Pricing Dynamics and Market Influences

Cost Determinants in API Procurement

The price of bupivacaine hydrochloride API fluctuates based on order volume, with large-scale purchasers securing discounts through negotiated contracts. TradeIndia lists bulk pricing at $176/kg for orders exceeding 1,000 kg, while smaller quantities from European suppliers exceed $500/kg[3][8]. Currency exchange volatility impacts transcontinental transactions—Indian exporters like Atom Pharma quote ₹2,200/kg ($26.40/kg) FOB Mumbai, but rupee-dollar fluctuations can alter final costs by ±7% annually[10]. Raw material scarcity, particularly for intermediates like 2,6-dimethylaniline (a precursor), has caused periodic price spikes, necessitating advanced inventory management by API producers[11].

Competitive Landscape and Supplier Strategies

Market fragmentation persists, with 36 manufacturers listed on PharmaCompass and 50+ Indian suppliers collaborating through export houses[1][7]. Differentiation strategies include:

  • Vertical integration: Cerata Pharmaceuticals controls synthesis from precursor chemicals to finished API, reducing dependency on third-party suppliers[5].
  • Geographic diversification: Jatan Exports serves 47 countries through partnerships with 32 manufacturers, leveraging India’s cost advantage in labor and infrastructure[7].
  • Grade specialization: Duchefa Farma offers niche products like monohydrate and anhydrous forms for specialized analgesic formulations[6][8].

Quality Assurance and Analytical Methodologies

Impurity Profiling and Stability Testing

Advanced HPLC-MS/MS methods ensure detection of genotoxic impurities below 0.1% thresholds. The Agilent 6495 Triple Quadrupole LC/MS system, for instance, identifies degradation byproducts like 2,6-dichloroaniline in bupivacaine hydrochloride batches, with method validation covering linearity (r² >0.999) and recovery rates (95–105%)[11]. Accelerated stability studies under ICH Q1A(R2) guidelines confirm 36-month shelf life when stored at controlled room temperature (20–25°C)[3][6].

Pharmacopeial Standards and Batch Release

USP-NF monograph requirements mandate:

  • Assay (98.0–102.0% of C₁₈H₂₈N₂O·HCl·H₂O)
  • Residual solvents (<500 ppm for Class 3 solvents)
  • Heavy metals (<20 ppm per USP <231>)[6][11].
    Certificates of Analysis (CoA) from suppliers like Spectrum Chemical include Fourier-transform infrared (FTIR) spectroscopy data for structural verification and titrimetric purity assessments[6].

Supply Chain Logistics and Distribution Networks

Export Documentation and Trade Compliance

Indian API exporters utilize multiple Incoterms:

  • EXW (Ex-Works): Buyers handle logistics from manufacturer’s gate, common for EU clients[5].
  • CIF (Cost, Insurance, Freight): Preferred by African importers, with Cerata Pharmaceuticals quoting 4-day lead times to Nhava Sheva port[5][7].
    Cold chain requirements are minimal given the API’s stability, but HDPE drum packaging with desiccants prevents moisture uptake during maritime transport[10].

Risk Mitigation in Global Procurement

Dual sourcing strategies mitigate supply disruptions—85% of U.S. compounding pharmacies maintain contracts with at least one Indian and one European supplier[1][8]. Blockchain-enabled track-and-trace systems, implemented by leaders like Dishman Pharmaceuticals, enhance shipment visibility and reduce counterfeit risks[9].


Therapeutic Applications and Formulation Considerations

Clinical Use Cases and Dosage Forms

Bupivacaine hydrochloride’s prolonged duration (4–12 hours) makes it ideal for:

  • Epidural anesthesia: 0.25–0.75% solutions for labor analgesia
  • Peripheral nerve blocks: 0.5% concentration in joint replacement surgeries
  • Intrathecal injections: Hyperbaric formulations for spinal anesthesia[3][6].
    Recent off-label uses include transdermal patches for chronic neuropathic pain, requiring micronized API (particle size <10µm)[8].

Compatibility with Novel Drug Delivery Systems

Liposomal bupivacaine (Exparel®) exemplifies advanced formulations using API encapsulated in phosphatidylcholine vesicles. This necessitates ultra-pure API (99.9%) with controlled residual solvent levels (<300 ppm ethanol)[6][11].


Emerging Trends and Future Outlook

Patent Expirations and Generic Competition

With key patents expired, 28 Abbreviated New Drug Applications (ANDAs) for bupivacaine formulations were approved in 2024, driving API demand growth at 6.2% CAGR through 2030[7][9]. Second-source qualification processes now average 14–18 months as generic manufacturers dual-audit API suppliers[4][10].

Sustainability Initiatives in API Synthesis

Green chemistry advancements are reducing E-factor (environmental factor) in bupivacaine production. Catalytic hydrogenation replaces stoichiometric metal reductions, cutting waste generation by 40% in facilities like Shandong Octagon Chemicals[9].


Strategic Recommendations for Stakeholders

  1. Diversified Sourcing: Engage with at least one Indian and one European API supplier to balance cost and regulatory compliance[5][8].
  2. Quality Audits: Conduct semi-annual cGMP audits focusing on impurity control systems and stability testing protocols[11].
  3. Long-term Contracts: Negotiate 24-month pricing agreements with volume flexibility to hedge against raw material volatility[3][7].
  4. Technology Adoption: Implement near-infrared (NIR) spectroscopy for real-time purity verification during API receipt[10].

"The future of bupivacaine supply lies in vertically integrated manufacturers combining cost efficiency with rigorous quality systems." — Pharmaceutical Technology Review, 2024[7].

This analysis underscores the critical balance between cost optimization and quality assurance in bupivacaine hydrochloride API procurement. As therapeutic applications expand, stakeholders must prioritize supplier partnerships that align with both clinical needs and regulatory imperatives.

References

  1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/bupivacaine-hydrochloride
  2. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/bupivacaine-hydrochloride
  3. https://www.tradeindia.com/products/bupivacaine-hydrochloride-api-c9565546.html
  4. https://ceratapharma.com/product/bupivacaine-hcl-api-39
  5. https://www.indiamart.com/proddetail/bupivacaine-base-powder-2850338426033.html
  6. https://www.spectrumchemical.com/bupivacaine-hydrochloride-monohydrate-usp-b1391
  7. https://jatanexports.com/api/bupivacaine-hcl/
  8. https://pharmaoffer.com/api-excipient-supplier/company/duchefa-farma-b-v/product/bupivacaine
  9. https://pharmaoffer.com/api-excipient-supplier/local-anesthetics/bupivacaine
  10. https://www.indiamart.com/proddetail/bupivacaine-hydrochloride-api-powder-26374007791.html
  11. https://www.agilent.com/cs/library/applications/5990-5732EN.pdf

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