Active Pharmaceutical Ingredient

Pramoxine API Manufacturer & Bulk Supplier in India | MEDIOCON INC

CAS: 140-65-8 Active Pharmaceutical Ingredient USP / EP / BP / IP GMP Certified Aurangabad, Maharashtra, India
Pramoxine API Manufacturer & Bulk Supplier in India | MEDIOCON INC — Mediocon Inc
Pramoxine API Manufacturer & Bulk Supplier in India | MEDIOCON INC

Product Overview

CAS No: 140-65-8 | Grade: USP / EP / BP / IP | Category: Active Pharmaceutical Ingredient

Pramoxine API Manufacturer & Bulk Supplier

Pramoxine API (also known as Pramocaine) is a premium-quality pharmaceutical-grade Active Pharmaceutical Ingredient (API) widely used in the formulation of topical local anesthetic and antipruritic medications. Pramoxine is a surface local anesthetic that provides rapid relief from itching, pain, burning, insect bites, hemorrhoids, eczema, dermatitis, minor cuts, sunburn, and other skin irritations. It acts by reversibly blocking nerve impulse conduction, thereby reducing pain and itching at the site of application. Its exceptional purity, excellent chemical stability, and consistent batch-to-batch quality make it suitable for pharmaceutical formulation development, analytical testing, quality control, stability studies, and authorized pharmaceutical research applications.

MEDIOCON INC is a trusted Pramoxine API manufacturer and bulk supplier in India, supplying premium-quality pharmaceutical ingredients to pharmaceutical companies, biotechnology organizations, contract manufacturing organizations (CMOs), formulation developers, research laboratories, and international distributors. Our GMP-compliant manufacturing facilities utilize advanced manufacturing technologies and stringent quality management systems to ensure superior purity, consistency, and compliance with international pharmaceutical quality standards.

Every batch of Pramoxine API manufactured by MEDIOCON INC undergoes comprehensive analytical testing using validated quality control methods. Critical quality parameters including identity, assay, impurity profile, moisture content, pH, melting point, specific rotation, residual solvents, particle size distribution, heavy metals, and stability are carefully evaluated before commercial release to ensure compliance with stringent pharmaceutical specifications.

Our Pramoxine API is available in USP, EP, BP, IP, and Pharmaceutical Grade, making it suitable for topical creams, lotions, gels, ointments, hemorrhoid preparations, antipruritic formulations, analytical testing, formulation development, quality control laboratories, stability studies, pharmaceutical process validation, and dermatological pharmaceutical research. We also provide complete regulatory documentation, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and supporting regulatory documents, ensuring smooth procurement and regulatory compliance.

With a strong commitment to quality, innovation, and customer satisfaction, MEDIOCON INC has established itself as a dependable global supplier of pharmaceutical raw materials. Through secure packaging, competitive pricing, efficient logistics, and responsive technical support, we ensure reliable worldwide delivery of premium-quality Pramoxine API.

If you are looking for a trusted Pramoxine API manufacturer, exporter, and bulk supplier, MEDIOCON INC provides pharmaceutical-grade ingredients backed by complete documentation, consistent quality, and timely worldwide supply.

Product Specifications

Product NamePramoxine API Manufacturer & Bulk Supplier in India | MEDIOCON INC
CAS Number140-65-8
CategoryActive Pharmaceutical Ingredient
GradeUSP / EP / BP / IP
AppearanceWhite to Off-White Crystalline Powder
StandardsUSP / EP / BP / IP

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR, HPLC & UV Complies
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 0.5%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)4.5 – 6.5
Individual ImpurityNMT 0.5%
Total ImpuritiesNMT 1.0%
Water ContentNMT 1.0%
Specific RotationNot Applicable (Achiral Compound)
Melting Point168°C – 174°C
SolubilityFreely Soluble in Water (Hydrochloride Salt), Soluble in Methanol and Ethanol

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Pramoxine API Manufacturer & Bulk Supplier in India | MEDIOCON INC (CAS 140-65-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Pramoxine API Manufacturer & Bulk Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Pramoxine API Manufacturer & Bulk Supplier in India | MEDIOCON INC

What is Pramoxine API used for?
Pramoxine API is used in topical pharmaceutical formulations for the temporary relief of itching, pain, burning, hemorrhoids, insect bites, eczema, dermatitis, and other minor skin irritations.
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