Active Pharmaceutical Ingredient

Folic Acid API Manufacturer & Supplier in India

Also known as: Vitamin B9 / Folate

CAS: 59-30-3 Vitamin / Nutritional Supplement IP / BP / USP Bulk Supply Available
Folic Acid API Manufacturer India | Mediocon Inc
Folic Acid — Pharmaceutical Grade API

Product Overview

CAS No: 59-30-3  |  MF: C₁₉H₁₉N₇O₆  |  MW: 441.40 g/mol

Folic Acid (Vitamin B9) is an essential water-soluble vitamin critical for DNA synthesis, cell division, and neural tube development. It is widely used in prenatal supplements, anemia treatment, and as a complementary agent in methotrexate therapy.

Mediocon Inc manufactures Folic Acid IP/BP/USP as a high-purity active pharmaceutical ingredient for nutraceutical, dietary supplement, and pharmaceutical manufacturers. Our Folic Acid is consistently manufactured with strict quality controls ensuring high potency and stability.

Key Features

  • Essential B-vitamin (Vitamin B9)
  • Critical for DNA synthesis & cell division
  • Pharmaceutical & nutraceutical grade
  • Complies IP/BP/USP

Applications

  • Prenatal & antenatal vitamin supplements
  • Megaloblastic anemia treatment formulations
  • Methotrexate combination therapy
  • Fortified food & nutraceutical manufacturing

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameFolic Acid
CAS Number59-30-3
Molecular FormulaC₁₉H₁₉N₇O₆
Molecular Weight441.40 g/mol
CategoryVitamin / Nutritional Supplement
AppearanceYellow to Orange-Yellow Crystalline Powder
GradeIP / BP / USP
Packaging25 kg HDPE Drums / Aluminium Bags
StorageCool, Dry & Ventilated Place

Analytical Specifications

ParameterSpecification
AssayNLT 96.0% (Dried Basis)
Loss on DryingNMT 8.5%
Heavy MetalsNMT 10 ppm
Residue on IgnitionNMT 0.3%
Microbial LimitsComplies
IdentificationUV & HPLC Compliant
pH (0.5% solution)4.0 – 5.0
Packing25 kg HDPE drums / as per requirement

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 Folic Acid (CAS 59-30-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Folic Acid 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 — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — 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
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Folic Acid API

What is the minimum order quantity for Folic Acid API?
Mediocon Inc supplies Folic Acid with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Folic Acid does Mediocon supply?
We supply Folic Acid conforming to IP / BP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Folic Acid API?
Every shipment of Folic Acid comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Folic Acid bulk orders?
Standard lead time for Folic Acid is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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