Active Pharmaceutical Ingredient

Dipivefrin Manufacturer & Supplier in India

Also known as: Dipivalyl Epinephrine, Propine

CAS: 52365-63-6 Prodrug Sympathomimetic (Anti-Glaucoma Agent) IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Dipivefrin API — Mediocon Inc
Dipivefrin — Pharmaceutical Grade API

Product Overview

CAS No: 52365-63-6  |  MF: C19H27NO5  |  MW: 349.42

Dipivefrin is a pharmaceutical-grade active ingredient classified as Prodrug Sympathomimetic (Anti-Glaucoma Agent). Mediocon Inc supplies high-purity Dipivefrin API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Dipivefrin is a prodrug that is enzymatically hydrolyzed in the cornea to epinephrine, reducing intraocular pressure by decreasing aqueous humor production and enhancing outflow. It is used as a critical raw material in finished dosage form manufacturing for global pharmaceutical markets.

Key Features

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

Applications

  • Open-angle glaucoma treatment
  • Ocular hypertension management
  • Ophthalmic formulation development
  • Glaucoma combination therapy research

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 NameDipivefrin
CAS Number52365-63-6
Molecular FormulaC19H27NO5
Molecular Weight349.42
CategoryProdrug Sympathomimetic (Anti-Glaucoma Agent)
AppearanceWhite to off-white crystalline powder
GradeIP / BP / EP / USP
Batch NoMDCDIP2503035
Mfg DateMAR 2025
Exp DateFEB 2030
Quantity25.00 Kg
Gross Weight26.00 Kg

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
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 Dipivefrin (pharmaceutical grade) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Dipivefrin 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 — Dipivefrin API

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