Active Pharmaceutical Ingredient

Ivabradine Hydrochloride API Manufacturer and Supplier in India

CAS: 148849-67-6 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Ivabradine Hydrochloride API Manufacturer and Supplier in India — Mediocon Inc
Ivabradine Hydrochloride API Manufacturer and Supplier in India

Product Overview

CAS No: 148849-67-6 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Ivabradine Hydrochloride is the hydrochloride salt of Ivabradine, a selective heart-rate-lowering pharmaceutical active ingredient. It acts primarily by selectively inhibiting the If (“funny”) current in the sinoatrial node, thereby reducing heart rate without directly reducing myocardial contractility.

Ivabradine Hydrochloride API

Ivabradine Hydrochloride is a selective HCN channel blocker used in cardiovascular pharmaceutical formulations. By reducing the spontaneous pacemaker activity of the sinoatrial node, it lowers heart rate and consequently reduces cardiac workload and myocardial oxygen demand.

Ivabradine Hydrochloride is used in approved pharmaceutical products for specific cardiovascular indications, including certain patients with chronic heart failure and stable symptomatic chronic heart failure, depending on the applicable regulatory jurisdiction and labeling.

Chemical Information

Product Name: Ivabradine Hydrochloride
CAS Number: 148849-67-6
Molecular Formula: C₂₇H₃₇ClN₂O₅
Molecular Weight: 505.05 g/mol
Chemical Class: Benzazepine Derivative
Therapeutic Class: Heart-Rate-Lowering Agent / Cardiovascular API
Salt Form: Hydrochloride
Parent Compound: Ivabradine
Parent CAS Number: 155974-00-8
Development Code: S 16257
IUPAC Name: 3-{3-[({[(7S)-3,4-dimethoxy-1,2,3,4-tetrahydronaphthalen-1-yl]methyl}amino)carbonyl]-4,5-dimethoxyphenyl}-N,N-dimethylpropan-1-amine hydrochloride
Synonyms: Ivabradine Hydrochloride, Ivabradine HCl, Ivabradine Hydrochloride Hemihydrate

Mechanism of Action

Ivabradine selectively inhibits the If current in the sinoatrial node.

The If current contributes to spontaneous diastolic depolarization and determines the rate at which the sinoatrial node generates impulses. By reducing this current, Ivabradine slows the heart rate.

Unlike conventional beta-blockers, Ivabradine primarily reduces heart rate without directly reducing myocardial contractility or significantly affecting atrioventricular conduction.

Manufacturing and Quality

MEDIOCON INC focuses on supplying pharmaceutical active ingredients with emphasis on quality, consistency, technical documentation and reliable supply.

Ivabradine Hydrochloride quality evaluation may include:

  • Identification
  • Assay by HPLC
  • Related substances
  • Enantiomeric purity
  • Residual solvents
  • Loss on drying
  • Residue on ignition
  • Heavy metals
  • Water content
  • pH
  • Other product-specific analytical parameters

The exact acceptance criteria should be confirmed against the current applicable specification and batch-specific Certificate of Analysis.

Applications

Ivabradine Hydrochloride may be used in:

  • Cardiovascular pharmaceutical formulations
  • Chronic heart failure formulations
  • Stable chronic heart failure treatment
  • Heart-rate management
  • Cardiovascular drug research
  • Pharmaceutical research and development

The approved indication, dosage and patient eligibility depend on the regulatory jurisdiction and applicable product labeling.

Product Characteristics

Ivabradine Hydrochloride is generally described as a white to off-white crystalline powder.

Appearance: White to off-white crystalline powder

The exact commercial appearance specification should be confirmed against the applicable MEDIOCON INC specification and batch COA.

Packaging and Documentation

Product availability, packaging configuration, Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), technical specifications and analytical documentation should be confirmed with MEDIOCON INC according to customer requirements and applicable regulatory standards.

Product Specifications

Product NameIvabradine Hydrochloride API Manufacturer and Supplier in India
CAS Number148849-67-6
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to off-white crystalline powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to off-white crystalline powder

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 Ivabradine Hydrochloride API Manufacturer and Supplier in India (CAS 148849-67-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Ivabradine Hydrochloride API Manufacturer and Supplier in India 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 — Ivabradine Hydrochloride API Manufacturer and Supplier in India

What is Ivabradine Hydrochloride?
Ivabradine Hydrochloride is the hydrochloride salt of Ivabradine, a selective heart-rate-lowering cardiovascular API.
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