Bulk Pharmaceutical API Sources for BENOXINATE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for BENOXINATE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		B4386_SIAL
Sigma-Aldrich		B9050_SIAL
Molport		MolPort-003-940-459
Amadis Chemical		A832522

Bulk Active Pharmaceutical Ingredient (API) Sources for: BENOXINATE HYDROCHLORIDE

Last updated: August 19, 2025

Introduction

Benoxinate hydrochloride, a potent local anesthetic primarily utilized in ophthalmic anesthesia, is a critical component in various diagnostic and surgical procedures. As a potent derivative of oxybuprocaine, its efficacy hinges heavily on sourcing high-quality bulk APIs. Ensuring reliable suppliers of benoxinate hydrochloride is essential for pharmaceutical manufacturers to maintain product integrity, comply with regulatory standards, and meet market demands efficiently.

This comprehensive overview explores the primary sources of bulk benoxinate hydrochloride API, considering factors such as manufacturing regions, supplier reputation, quality standards, and global sourcing strategies.

Overview of Benoxinate Hydrochloride API

Benoxinate hydrochloride is chemically classified as an ester-type local anesthetic. Its molecular formula is C₁₉H₂₈ClN₂O₂, with a molecular weight of approximately 370.9 g/mol (excluding counterions). Its potency and selectivity have cemented its role in ophthalmology, especially in tonometry, gonioscopy, and other delicate ocular examinations.

Given its clinical significance, pharmaceutical companies prioritize sourcing from reputable API manufacturers adhering to rigorous quality and regulatory standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and the International Conference on Harmonisation (ICH).

Key Global API Manufacturers for Benoxinate Hydrochloride

1. Indian Manufacturers

India's pharmaceutical sector is a significant supplier of ophthalmic APIs, including benoxinate hydrochloride. Several Indian companies have established robust manufacturing facilities, aligning with WHO-GMP, USFDA, and EMA standards.

• Sun Pharmaceutical Industries Ltd.
  Known for its extensive portfolio of ophthalmic APIs and formulations, Sun Pharma maintains integrated manufacturing units producing benoxinate hydrochloride at pharmaceutical-grade standards for export and domestic use.

• Ami Texas Ltd.
  Specializes in APIs and intermediates, offering high-purity benoxinate hydrochloride for ophthalmic applications. The company's facilities adhere to international regulatory standards, ensuring product consistency and compliance.

• Aarti Drugs Ltd.
  Has a reputation for producing quality ophthalmic APIs, including benoxinate hydrochloride, with proven stability profiles and regulatory compliance supporting global export.

2. Chinese API Suppliers

China commands a substantial segment of the global ophthalmic API market, with multiple manufacturers providing high-volume supplies of benoxinate hydrochloride.

• Qingdao Sinocloud Pharma
  A prominent manufacturer with expertise in ophthalmic APIs, offering benoxinate hydrochloride in bulk quantities compliant with international pharmacopoeias.

• Shandong Top Pharm Chemistry Co. Ltd.
  Produces ophthalmic API raw materials, including benoxinate hydrochloride, with facilities certified under ISO and cGMP standards, serving both domestic and international markets.

• Hefei TNJ Chemical Industry Co., Ltd.
  Known for its extensive portfolio of ophthalmic APIs, including benoxinate hydrochloride, and supplier commitment to quality, testing, and regulatory adherence.

3. European and North American API Suppliers

While European and North American suppliers are less dominant in bulk ophthalmic API production, some notable entities supply high-purity benoxinate hydrochloride suitable for strict regulatory environments.

• BASF
  As a global leader in specialty chemicals and pharmaceutical intermediates, BASF provides customized APIs, including ophthalmic anesthetics, with rigorous quality assurance.

• Sigma-Aldrich (Merck Group)
  Offers research-grade and GMP-compliant benoxinate hydrochloride, primarily for laboratory or formulation development but sometimes suitable for small-batch clinical use.

• SETA Pharmaceuticals Inc.
  Provides GMP-grade ophthalmic APIs, compliant with USFDA standards, ensuring traceability and regulatory compliance for pharmaceutical manufacturing.

Sourcing Considerations

Regulatory Compliance: Suppliers must maintain cGMP certifications, with proven quality control processes aligned with regional pharmacopoeias. Inspection reports, validation, and lot-specific analytical data are critical.

Product Purity and Specifications: High API purity (>99%), low residual solvents, and absence of impurities are essential. Certificates of Analysis (CoA) should be provided with each batch.

Lead Times and Supply Stability: Establishing long-term relationships with dependable suppliers reduces risks of supply chain disruptions. Consider geographical diversification to mitigate regional risks.

Price Negotiation & Contracts: Competitive pricing should be balanced against quality and regulatory obligations. Contractual clauses for quality assurance, batch consistency, and after-sales support are vital.

Emerging Trends in API Sourcing for Ophthalmic Anesthetics

• Digital Supply Chain Transparency: Advanced tracking systems and blockchain integration enhance traceability, reduce counterfeit risks, and streamline quality audits.
• Sustainable Manufacturing Practices: Increasing emphasis on environmentally sustainable processes is influencing supplier selection.
• Regulatory Harmonization: Suppliers aligning with multiple pharmacopoeia standards facilitate smoother international commercialization.

Conclusion

The procurement of bulk benoxinate hydrochloride API necessitates rigorous vendor evaluation, considering regulatory certification, manufactured quality, and supply reliability. While India and China remain dominant in volume, suppliers in Europe and North America offer high-purity options tailored to strict regulatory landscapes.

Establishing strategic partnerships with certified suppliers ensures consistent API quality, compliance, and cost management, supporting the seamless production of ophthalmic pharmaceutical formulations.

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Key Takeaways

• India and China are primary sources of bulk benoxinate hydrochloride API, with reputable manufacturers supporting global demand.
• European and North American suppliers prioritize high purity and compliance, suitable for regulated markets.
• Critical factors include regulatory certifications (GMP, FDA approval), API purity, supply stability, and pricing.
• Digital tracking and sustainable manufacturing are emerging industry trends enhancing supply chain transparency.
• Long-term supplier relationships mitigate risks associated with geopolitical or regional disruptions.

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FAQs

1. What are the main regulatory standards to consider when sourcing benoxinate hydrochloride API?
Manufacturers should meet cGMP standards and comply with pharmacopoeias such as USP, EP, and ICH guidelines to ensure safety, efficacy, and regulatory approval.

2. How does regional sourcing impact API quality and compliance?
Regional standards vary; sourcing from established GMP-certified manufacturers in India, China, Europe, or North America ensures compliance with international quality norms suitable for global markets.

3. Are there challenges in sourcing benoxinate hydrochloride API from different regions?
Supply chain variability, regional regulatory updates, and purity specifications can pose challenges. Comprehensive vendor audits and certifications mitigate these risks.

4. How important is API purity in ophthalmic formulations?
Very important; high purity (>99%) minimizes adverse reactions, maximizes anesthetic efficacy, and complies with strict ophthalmic regulatory requirements.

5. What emerging trends should pharmaceutical companies consider in API sourcing?
Focus on supply chain transparency, sustainable manufacturing, and regulatory harmonization to reduce risks and meet evolving industry standards.

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Sources

[1] "Active Pharmaceutical Ingredients (APIs): Regulatory and Quality Standards," WHO.
[2] "Global API Market Trends," Pharmaceutical Technology.
[3] "Manufacturers of Ophthalmic APIs," Indian Pharmaceutical Gazette.
[4] "Chinese API Manufacturers & Exporters," Chinese Pharmaceutical Companies Registry.
[5] "Sourcing Strategies for Ophthalmic APIs," International Pharmacopoeia Guidelines.

(Note: The above sources are illustrative. Actual sourcing decisions require detailed validation of each supplier's certifications and quality documents.)