Active Pharmaceutical Ingredient

Nystatin API Manufacturer & Bulk Supplier in India

CAS: 1400-61-9 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Nystatin API Manufacturer & Bulk Supplier in India — Mediocon Inc
Nystatin API Manufacturer & Bulk Supplier in India

Product Overview

CAS No: 1400-61-9 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Nystatin API Manufacturer & Supplier

MEDIOCON INC is a trusted manufacturer, exporter, and bulk supplier of Nystatin API (Active Pharmaceutical Ingredient), offering premium pharmaceutical-grade raw material for formulation development, commercial pharmaceutical manufacturing, analytical testing, quality control laboratories, stability studies, and authorized pharmaceutical research applications. MEDIOCON INC manufactures Nystatin API under stringent quality management systems to ensure exceptional purity, batch-to-batch consistency, and compliance with international pharmaceutical standards.

Nystatin is a polyene antifungal active pharmaceutical ingredient widely used in pharmaceutical formulations for the prevention and treatment of fungal infections caused by Candida species. It is commonly incorporated into oral suspensions, tablets, capsules, creams, ointments, powders, vaginal preparations, and topical formulations. The API is extensively utilized in formulation development, analytical method validation, process optimization, stability studies, and quality control applications. MEDIOCON INC supplies high-quality Nystatin API that meets stringent pharmaceutical quality standards for domestic and international pharmaceutical markets.

Every production batch manufactured by MEDIOCON INC undergoes comprehensive quality testing including identification, potency assay, impurity profiling, moisture determination, heavy metal analysis, microbiological evaluation, and other critical quality assessments. This rigorous quality assurance program ensures excellent pharmaceutical performance, product stability, potency, and batch-to-batch consistency.

MEDIOCON INC supplies Nystatin API to pharmaceutical manufacturers, formulation companies, contract manufacturing organizations (CMOs), research laboratories, healthcare institutions, and distributors across domestic and international markets. We provide competitive pricing, dependable bulk supply, worldwide logistics support, and complete regulatory documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and supporting quality documents upon request.

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

Product Specifications

Product NameNystatin API Manufacturer & Bulk Supplier in India
CAS Number1400-61-9
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceLight Yellow to Yellow Hygroscopic Powder
StandardsIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AppearanceLight Yellow to Yellow Hygroscopic Powder
IdentificationHPLC & UV Complies
Assay (HPLC)≥ 4400 IU/mg
Loss on DryingNMT 5.0%
Residue on IgnitionNMT 1.0%
Heavy MetalsNMT 10 ppm
pH (1% Solution)6.0 – 8.0
Individual ImpurityNMT 1.0%
Total ImpuritiesNMT 2.0%
Water ContentNMT 5.0%
Specific Rotation+180° to +200°
Melting Point160°C – 170°C
SolubilitySlightly Soluble in Methanol; Practically Insoluble in Water

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 Nystatin API Manufacturer & Bulk Supplier in India (CAS 1400-61-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Nystatin 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 — Nystatin API Manufacturer & Bulk Supplier in India

What is Nystatin API used for?
Nystatin API is widely used in pharmaceutical formulations for the prevention and treatment of fungal infections caused by Candida species, including oral, topical, and vaginal formulations.
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