Active Pharmaceutical Ingredient

Ramipril API Manufacturer & Supplier in India

Also known as: Altace; Tritace; Ramace

CAS: 87333-19-5 ACE Inhibitor IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Ramipril API — Mediocon Inc
Ramipril — Pharmaceutical Grade API

Product Overview

CAS No: 87333-19-5  |  MF: C₂₃H₃₂N₂O₅  |  MW: 416.51 g/mol

Ramipril is a pharmaceutical-grade active ingredient classified as an ACE Inhibitor Antihypertensive. Mediocon Inc supplies high-purity Ramipril API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Ramipril is a prodrug ACE inhibitor converted in vivo to ramiprilat, its active metabolite. It is used in the treatment of hypertension, heart failure, diabetic nephropathy, and for the prevention of myocardial infarction, stroke, and cardiovascular death in high-risk patients. Ramipril has demonstrated significant cardiovascular protective effects in major clinical trials.

Key Features

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

Applications

  • Hypertension (including high-risk patients)
  • Heart failure post-myocardial infarction
  • Cardiovascular risk reduction (HOPE trial population)
  • Diabetic and non-diabetic nephropathy

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 NameRamipril
Also Known AsAltace; Tritace; Ramace
CAS Number87333-19-5
Molecular FormulaC₂₃H₃₂N₂O₅
Molecular Weight416.51 g/mol
CategoryACE Inhibitor — Antihypertensive
AppearanceWhite to off-white crystalline powder
SolubilitySparingly soluble in water; freely soluble in methanol and 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
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 Ramipril (CAS 87333-19-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Ramipril 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 — Ramipril API

What is the minimum order quantity for Ramipril API?
Mediocon Inc supplies Ramipril 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 Ramipril does Mediocon supply?
We supply Ramipril 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 Ramipril API?
Every shipment of Ramipril 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 Ramipril bulk orders?
Standard lead time for Ramipril 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.
💬
Mediocon AI
Hello 👋 How can I help you today?