Active Pharmaceutical Ingredient

Tripolidine API Manufacturer & Supplier in India

Also known as: Actidil; Pro-Actidil

CAS: 486-12-4Antihistamine APIIP / BP / EP / USPGMP CertifiedAurangabad, Maharashtra, India
Tripolidine API — Mediocon Inc
Tripolidine — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 486-12-4  |  MF: C₁₉H₂₂N₂  |  MW: 278.39 g/mol

Tripolidine is a high-purity Active Pharmaceutical Ingredient supplied by Mediocon Inc conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India.

Tripolidine is a first-generation H1 antihistamine with sedative properties used for the relief of allergic conditions. It competitively antagonizes histamine at H1 receptor sites and is commonly combined with pseudoephedrine in cough and cold preparations for the treatment of nasal congestion and allergic rhinitis.

Key Features

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

Applications

  • Allergic rhinitis treatment
  • Common cold symptom relief
  • Antihistamine combination formulations
  • Urticaria and pruritus 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 NameTripolidine
Also Known AsActidil; Pro-Actidil
CAS Number486-12-4
Molecular FormulaC₁₉H₂₂N₂
Molecular Weight278.39 g/mol
CategoryAntihistamine (H1 Antagonist)
AppearanceWhite to off-white crystalline powder
SolubilitySparingly soluble in water; freely soluble in ethanol and chloroform
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.TRP/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 Tripolidine (CAS 486-12-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Tripolidine 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 — Tripolidine API

What is the minimum order quantity for Tripolidine API?
Mediocon Inc supplies Tripolidine 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 Tripolidine does Mediocon supply?
We supply Tripolidine 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 Tripolidine API?
Every shipment of Tripolidine 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 Tripolidine bulk orders?
Standard lead time for Tripolidine 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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