Active Pharmaceutical Ingredient

Niacinamide API Manufacturer & Supplier

CAS: 98-92-0 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Niacinamide API Manufacturer & Supplier — Mediocon Inc
Niacinamide API Manufacturer & Supplier

Product Overview

CAS No: 98-92-0 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Niacinamide API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Niacinamide API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, nutraceutical formulations, dermatological products, 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.

Niacinamide, also known as Nicotinamide or Vitamin B3, is a water-soluble vitamin widely used in pharmaceutical, nutraceutical, cosmetic, and dermatological formulations. It plays a vital role in cellular energy metabolism by serving as a precursor to nicotinamide adenine dinucleotide (NAD⁺) and nicotinamide adenine dinucleotide phosphate (NADP⁺). Niacinamide is extensively used in the prevention and treatment of vitamin B3 deficiency, pellagra, acne, inflammatory skin disorders, hyperpigmentation, and various nutritional deficiencies. 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 Niacinamide API to pharmaceutical manufacturers, nutraceutical companies, cosmetic manufacturers, 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 NameNiacinamide API Manufacturer & Supplier
CAS Number98-92-0
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceWhite Crystalline Powder
StandardsIP / BP / EP / USP Compliant

Analytical Specifications

ParameterSpecification
AppearanceWhite Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Assay (HPLC)99.0% – 101.0%
Loss on DryingNMT 0.50%
Residue on IgnitionNMT 0.10%
Heavy MetalsNMT 10 ppm
pH (1% Solution)6.0 – 7.5
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 0.50%
Melting Point128°C – 131°C
SolubilityFreely soluble in water and ethanol; slightly soluble in glycerol

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 Niacinamide API Manufacturer & Supplier (CAS 98-92-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Niacinamide 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 — Niacinamide API Manufacturer & Supplier

What is Niacinamide API?
Niacinamide API, also known as Nicotinamide or Vitamin B3, is a water-soluble vitamin widely used in pharmaceutical, nutraceutical, and dermatological formulations.
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