WHO-GMP certified production with complete DMF support.
Availability: In Stock | Grade: Medicinal
Benzocaine is a local anesthetic active pharmaceutical ingredient (API) used in topical and oral pharmaceutical formulations to provide temporary relief from pain, irritation, and discomfort.
Surya Life Sciences Ltd. is a Benzocaine API manufacturer and supplier serving regulated and semi-regulated pharmaceutical markets worldwide. We support pharmaceutical companies with high-quality Benzocaine raw material for formulation development and commercial manufacturing.
Our four WHO-GMP-approved manufacturing facilities, certified to ISO 9001:2015, operate in compliance with applicable environmental, quality, and safety requirements. This enables consistent production of Benzocaine API for commercial manufacturing and product development programs.
Benzocaine API Key Specifications
The following specifications provide an overview of the physical and chemical characteristics of our Benzocaine API for pharmaceutical manufacturing and formulation development.
| Attribute | Specification |
|---|
| Chemical Name | Benzocaine |
| Category | Local Anesthetic |
| Therapeutic Use | Temporary relief of pain and irritation in topical and oral pharmaceutical formulations |
| Molecular Formula | C₉H₁₁NO₂ |
| Molecular Weight | 165.19 g/mol |
| Appearance | White-slightly yellow, crystals-crystalline powder |
| Solubility | - |
| Purity | - |
| Melting Point | 89-92°C |
| Shelf Life | - |
| Available Grades | Medicinal |
Why Choose Surya Life Sciences as Your Benzocaine API Manufacturer?
As a trusted Benzocaine API manufacturer, Surya Life Sciences combines manufacturing expertise, regulatory support, and dependable supply systems to help pharmaceutical companies move from development to commercial production with confidence.
Regulatory-Ready Documentation & DMF Support
Comprehensive documentation is available to support qualification, audits, and regulatory submissions across regulated and semi-regulated markets.
Documentation support may include:
- Drug Master File (DMF) support
- Product specifications
- Certificate of Analysis (CoA)
- Stability and analytical data
- Batch-specific documentation
Reliable Stock Availability & Supply Continuity
Our manufacturing and inventory planning systems are structured to support ongoing procurement requirements and minimize supply disruptions.
- Stock and production-based supply options
- Planned manufacturing schedules
- Defined dispatch timelines based on availability
- Long-term supply support for commercial customers
Easy Ordering & Commercial Flexibility
Whether the requirement is for product evaluation, scale-up activities, or commercial manufacturing, we support different procurement stages through a streamlined ordering process.
Available supply options include:
- Development quantities
- Pilot-scale requirements
- Commercial batch supply
Certified Quality & Compliance
Manufacturing operations are aligned with internationally recognized quality standards.
- WHO-GMP approved facilities
- ISO 9001:2015 certified operations
- Documented quality management systems
- Compliance-focused manufacturing practices
Bulk Benzocaine API Supply and Customization
As a Benzocaine API supplier and manufacturer, Surya Life Sciences supports scalable production and bulk supply programs, with manufacturing planning aligned to customer demand forecasts and procurement requirements.
Customization Options:
- Customized packaging configurations
- Batch sizing aligned to project requirements
- Supply planning for recurring procurement programs
- Export-oriented shipment support
Clinical Uses & Industry Applications of Benzocaine API
Benzocaine is a widely used local anesthetic API utilized in pharmaceutical formulations designed to provide temporary relief from pain, irritation, and localized discomfort, including:
Minor oral and gum irritation
Topical pain and itching associated with minor skin irritations
Localized anesthetic applications in over-the-counter healthcare products
Key industry applications of Benzocaine API include:
Finished Dosage Form Manufacturing
Used by pharmaceutical manufacturers in the production of topical creams, gels, sprays, lozenges, oral solutions, and other dosage forms requiring local anesthetic properties.
Generic Drug Development Programs
Integrated into generic formulation development projects where consistent API quality, regulatory documentation, and reproducible manufacturing performance are essential.
Contract Manufacturing & Private Label Supply
Supplied to CDMOs and third-party manufacturers supporting branded and private-label topical healthcare and oral care product portfolios.
Formulation R&D and Process Optimisation
Utilized during formulation screening, stability studies, scale-up activities, and process development programs requiring reliable physicochemical characteristics.
Regulated Export & International Supply Chains
Applied in export-oriented pharmaceutical manufacturing, where compliance with pharmacopeial standards, documentation requirements, and quality expectations is critical.
Consumer Healthcare Product Manufacturing
Widely used in the development of non-prescription healthcare products intended for temporary symptomatic relief through localized anesthetic action.
Storage, Packaging & Handling Information
Storage
Store in a cool, dry place in tightly closed containers protected from moisture and direct sunlight.
Packaging
- HDPE drums with suitable inner liners
- Pharmaceutical-grade packaging options available
- Customized packaging formats upon request
Handling
Handle in accordance with GMP procedures and applicable safety recommendations. Personnel should use appropriate protective equipment during material handling and processing.
Request Batch Details, Pricing, and Availability
Connect with our experts for Benzocaine API pricing, availability, technical documentation, regulatory assistance, bulk supply requirements, and tailored procurement solutions.
FAQs
Is Benzocaine API pharmacopeia compliant?
Benzocaine API is described in major pharmacopeial references, including USP, BP, and Ph. Eur., with established specifications for identity, purity, and quality attributes. Product-specific compliance details can be shared upon request.
Are DMFs applicable to regulated and semi-regulated markets?
Yes. Surya Life Sciences supports customers with DMF-related documentation and associated regulatory information for regulated and semi-regulated markets, subject to applicable regional requirements.
What is the typical delivery time for bulk API orders?
Dispatch timelines generally range from 7 to 15 days following order confirmation, depending on batch availability, quality release status, and order quantity. Exact timelines are confirmed during order processing.
What is the minimum order quantity (MOQ) for Benzocaine API?
The standard MOQ for Benzocaine API is 25 kg. Specific project requirements and commercial quantities can be discussed with our team.
Why choose Surya Life Sciences as your Benzocaine API manufacturer?
Surya Life Sciences operates WHO-GMP-approved manufacturing facilities and supplies Benzocaine API with regulatory documentation, DMF support, scalable production capacity, and dependable global supply capabilities for pharmaceutical manufacturers.