Active Pharmaceutical Ingredient

Methyl Aminolevulinate API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 79416-27-6 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Methyl Aminolevulinate API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Methyl Aminolevulinate API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 79416-27-6 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Methyl Aminolevulinate API

Methyl Aminolevulinate, commonly supplied as Methyl Aminolevulinate Hydrochloride (Methyl 5-Aminolevulinate Hydrochloride), is a pharmaceutical active ingredient belonging to the class of aminolevulinic acid derivatives. It is a hydrochloride salt of the methyl ester of 5-aminolevulinic acid and is used as a photosensitizer precursor in pharmaceutical and photodynamic therapy applications. MEDIOCON INC supplies quality-focused Methyl Aminolevulinate Hydrochloride for pharmaceutical development, formulation and bulk API requirements.

Methyl Aminolevulinate Hydrochloride is also known as Methyl 5-Aminolevulinate Hydrochloride, 5-Aminolevulinic Acid Methyl Ester Hydrochloride, Aminolevulinic Acid Methyl Ester Hydrochloride, Methyl 5-Amino-4-oxopentanoate Hydrochloride and Methyl Aminolevulinate HCl. The compound has the molecular formula C₆H₁₂ClNO₃ and molecular weight 181.62 g/mol. Its CAS number is 79416-27-6. These chemical identity details are confirmed by FDA's Global Substance Registration System and PubChem.

Methyl Aminolevulinate Hydrochloride is generally described as a white to almost white powder or crystalline solid. It is hygroscopic and sensitive to light and heat. TCI reports a melting-point specification of 120–124°C and describes the material as soluble in water.

Methyl Aminolevulinate Hydrochloride is an established pharmaceutical substance with a European Pharmacopoeia monograph numbered 3073. The monograph was adopted as a new Ph. Eur. text and subsequently incorporated into the European Pharmacopoeia.

MEDIOCON INC supplies Methyl Aminolevulinate Hydrochloride for pharmaceutical API requirements, analytical development, formulation development and commercial pharmaceutical applications. Product documentation such as COA, MSDS/SDS and technical specifications can be provided according to applicable product and customer requirements.

Methyl Aminolevulinate Hydrochloride is associated with photodynamic therapy because it is metabolized to protoporphyrin IX, a photoactive porphyrin. It is used in pharmaceutical products and research associated with conditions such as actinic keratosis and certain skin cancers.

MEDIOCON INC focuses on quality-oriented supply of Methyl Aminolevulinate API and pharmaceutical ingredients for domestic and international customers.

Product Specifications

Product NameMethyl Aminolevulinate API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number79416-27-6
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to almost white powder or crystalline solid
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to almost white powder or crystalline solid
IdentificationIR & HPLC Complies
Assay (HPLC)97.0% – 102.0%
Loss on Drying97.0% – 102.0%
Residue on IgnitionNMT 0.1%
Heavy MetalsNMT 10 ppm
pH (1% Solution)5.0 – 7.0
Individual ImpurityNMT 0.80%
Total ImpuritiesNMT 0.5%
Water ContentNMT 1.0%
Melting Point120°C – 124°C
Solubilitysoluble 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 Methyl Aminolevulinate API Manufacturer & Supplier in India | MEDIOCON INC (CAS 79416-27-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Methyl Aminolevulinate API Manufacturer & Supplier in India | MEDIOCON INC 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 — Methyl Aminolevulinate API Manufacturer & Supplier in India | MEDIOCON INC

What is Methyl Aminolevulinate?
Methyl Aminolevulinate is a pharmaceutical active ingredient commonly supplied as Methyl Aminolevulinate Hydrochloride. It is a methyl ester derivative of 5-aminolevulinic acid used in photodynamic therapy-related pharmaceutical applications.
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