Active Pharmaceutical Ingredient

Tromantadine API Manufacturer & Supplier in India

Also known as: Viru-Merz; N-(2-(1-Adamantyl)ethyl)glucamine

CAS: 53783-83-8Antiviral APIIP / BP / EP / USPGMP CertifiedAurangabad, Maharashtra, India
Tromantadine API — Mediocon Inc
Tromantadine — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 53783-83-8  |  MF: C₁₆H₃₁NO₅  |  MW: 321.42 g/mol

Tromantadine is a high-purity Active Pharmaceutical Ingredient supplied by Mediocon Inc conforming to IP / BP / EP / USP specifications. CAS No.: 151-42-2 (base). Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India.

Tromantadine is an antiviral agent structurally related to amantadine, used topically for the treatment of herpes simplex virus (HSV) infections of the skin and mucous membranes. It inhibits viral adsorption and penetration into host cells, and also inhibits virus uncoating and intracellular virus replication.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Herpes simplex virus (HSV) topical treatment
  • Herpes labialis (cold sores) therapy
  • Antiviral ophthalmic formulations
  • Mucocutaneous herpes management

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 NameTromantadine
Also Known AsViru-Merz; N-(2-(1-Adamantyl)ethyl)glucamine
CAS Number53783-83-8
Molecular FormulaC₁₆H₃₁NO₅
Molecular Weight321.42 g/mol
CategoryAntiviral Agent
AppearanceWhite to off-white crystalline powder
SolubilityFreely soluble in water; sparingly soluble in ethanol
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch No.TRM/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
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 Tromantadine (CAS 53783-83-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Tromantadine 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 — Tromantadine API

What is the minimum order quantity for Tromantadine API?
Mediocon Inc supplies Tromantadine 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 Tromantadine does Mediocon supply?
We supply Tromantadine conforming to IP / BP / EP / 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 Tromantadine API?
Every shipment of Tromantadine 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 Tromantadine bulk orders?
Standard lead time for Tromantadine 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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