Active Pharmaceutical Ingredient

Niceritrol API Manufacturer & Supplier

CAS: 55986-43-1 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Niceritrol API Manufacturer & Supplier — Mediocon Inc
Niceritrol API Manufacturer & Supplier

Product Overview

CAS No: 55986-43-1 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Niceritrol API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Niceritrol API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, formulation development, analytical testing, quality control, stability studies, and research applications. Every batch is manufactured under stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.

Niceritrol is a nicotinic acid derivative and lipid-lowering active pharmaceutical ingredient widely used in pharmaceutical formulations for the management of hyperlipidemia and dyslipidemia. It functions as a prolonged-release niacin derivative that helps reduce serum triglycerides and low-density lipoprotein (LDL) cholesterol while increasing high-density lipoprotein (HDL) cholesterol. Niceritrol has been extensively studied for cardiovascular risk reduction and metabolic disorder management. It is also widely utilized in pharmaceutical research, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Niceritrol API to pharmaceutical manufacturers, formulation companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), universities, research institutes, and analytical laboratories worldwide. Comprehensive documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and regulatory support documents is available upon request.

Product Specifications

Product NameNiceritrol API Manufacturer & Supplier
CAS Number55986-43-1
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to Off-White Crystalline Powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 0.50%
Residue on IgnitionNMT 0.20%
Heavy MetalsNMT 10 ppm
pH (1% Solution)5.0 – 7.5
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.50%
Water ContentNMT 0.50%
Melting Point145°C – 150°C
SolubilitySlightly soluble in water; 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 Niceritrol API Manufacturer & Supplier (CAS 55986-43-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Niceritrol API Manufacturer & Supplier 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 — Niceritrol API Manufacturer & Supplier

What is Niceritrol API?
Niceritrol API is a nicotinic acid derivative used as a lipid-lowering active pharmaceutical ingredient in pharmaceutical formulations and cardiovascular research.
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