Active Pharmaceutical Ingredient

Pantoprazole Sodium API Manufacturer & Bulk Supplier in India

CAS: 138786-67-1 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Pantoprazole Sodium API Manufacturer & Bulk Supplier in India — Mediocon Inc
Pantoprazole Sodium API Manufacturer & Bulk Supplier in India

Product Overview

CAS No: 138786-67-1 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Pantoprazole Sodium API Manufacturer & Supplier

MEDIOCON INC is a leading manufacturer, exporter, and bulk supplier of Pantoprazole Sodium API (Active Pharmaceutical Ingredient), delivering premium pharmaceutical-grade material for formulation development, commercial pharmaceutical manufacturing, analytical testing, quality control laboratories, stability studies, and authorized research applications. MEDIOCON INC manufactures Pantoprazole Sodium API under stringent quality management systems, ensuring high purity, consistent quality, and compliance with international pharmaceutical standards.

Pantoprazole Sodium is a proton pump inhibitor (PPI) active pharmaceutical ingredient widely used in pharmaceutical formulations for the treatment of gastroesophageal reflux disease (GERD), erosive esophagitis, Zollinger-Ellison syndrome, peptic ulcers, and other acid-related gastrointestinal disorders. The API is extensively utilized in tablet, capsule, injectable, and delayed-release pharmaceutical formulations. MEDIOCON INC supplies pharmaceutical-grade Pantoprazole Sodium API suitable for formulation development, analytical method validation, stability studies, process development, and commercial production.

Every production batch manufactured by MEDIOCON INC undergoes comprehensive quality testing, including identification, assay by HPLC, impurity profiling, loss on drying, water content determination, heavy metal analysis, residual solvent evaluation, and microbiological testing where applicable. This rigorous quality assurance program ensures excellent batch-to-batch consistency and reliable pharmaceutical performance.

MEDIOCON INC serves pharmaceutical manufacturers, contract manufacturing organizations (CMOs), formulation companies, research institutes, healthcare organizations, and distributors across domestic and international markets. We provide competitive pricing, dependable bulk supply, timely worldwide delivery, and complete regulatory documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and other supporting documents upon request.

Whether your organization requires Pantoprazole Sodium API for commercial manufacturing, pharmaceutical formulation development, validation batches, analytical testing, or research applications, MEDIOCON INC is committed to delivering superior-quality pharmaceutical ingredients backed by professional technical support and reliable global supply.

Product Specifications

Product NamePantoprazole Sodium API Manufacturer & Bulk Supplier in India
CAS Number138786-67-1
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceWhite to Off-White Crystalline Powder
StandardsIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR & HPLC Complies
Assay (HPLC)≥ 99.0%
Loss on DryingNMT 1.0%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)9.0 – 11.5
Individual ImpurityNMT 0.5%
Total ImpuritiesNMT 1.0%
Water ContentNMT 2.0%
Melting Point139°C – 145°C
SolubilityFreely Soluble in Water; Soluble in Methanol

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 Pantoprazole Sodium API Manufacturer & Bulk Supplier in India (CAS 138786-67-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Pantoprazole Sodium API Manufacturer & Bulk Supplier in India 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 — Pantoprazole Sodium API Manufacturer & Bulk Supplier in India

What is Pantoprazole Sodium API used for?
Pantoprazole Sodium API is used in pharmaceutical formulations for the treatment of GERD, peptic ulcers, Zollinger-Ellison syndrome, and other acid-related gastrointestinal disorders.
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