Active Pharmaceutical Ingredient

Labetalol Hydrochloride API Manufacturer and Supplier in India

CAS: 32780-64-6 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Labetalol Hydrochloride API Manufacturer and Supplier in India — Mediocon Inc
Labetalol Hydrochloride API Manufacturer and Supplier in India

Product Overview

CAS No: 32780-64-6 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Labetalol Hydrochloride is an adrenergic receptor-blocking pharmaceutical active ingredient with both selective α1-adrenergic blocking and non-selective β-adrenergic blocking activity. It is primarily used as an antihypertensive agent for the management of high blood pressure. Labetalol Hydrochloride has the molecular formula C₁₉H₂₄N₂O₃·HCl and molecular weight 364.87 g/mol.

Labetalol Hydrochloride API

Labetalol Hydrochloride is the hydrochloride salt of Labetalol and belongs to the adrenergic receptor antagonist class. Its combined α1- and β-adrenergic blocking activity produces vasodilation while also reducing cardiac sympathetic activity.

Labetalol Hydrochloride is identified by CAS Number 32780-64-6.

Chemical Information

Product Name: Labetalol Hydrochloride
CAS Number: 32780-64-6
Molecular Formula: C₁₉H₂₄N₂O₃·HCl
Molecular Weight: 364.87 g/mol
Chemical Class: Adrenergic receptor antagonist
Therapeutic Class: Antihypertensive / Alpha- and Beta-adrenergic blocker
Parent Compound: Labetalol
Parent CAS Number: 36894-69-6
PubChem CID: 71412

Labetalol Hydrochloride has two asymmetric centers and is present as a molecular complex of two diastereoisomeric pairs; the R,R' stereoisomer, dilevalol, represents approximately 25% of racemic labetalol.

Mechanism of Action

Labetalol Hydrochloride combines competitive α1-adrenergic receptor blockade with non-selective competitive β-adrenergic receptor blockade.

α1-receptor blockade reduces peripheral vascular resistance through vasodilation, while β-receptor blockade decreases sympathetic cardiac activity. Together, these effects contribute to reductions in blood pressure and heart rate.

Manufacturing and Quality

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

Labetalol Hydrochloride quality evaluation may include identification, assay, chromatographic purity, related substances, residual solvents, water content, residue on ignition and other parameters according to the applicable product specification.

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

Applications

Labetalol Hydrochloride is used as an antihypertensive pharmaceutical ingredient. It is formulated for oral administration and is also used in injectable formulations for appropriate clinical settings.

The exact indication, dosage form and regulatory requirements should be confirmed according to the applicable market authorization and current prescribing information.

Product Characteristics

Official drug labeling describes Labetalol Hydrochloride as a white to off-white crystalline powder. Depending on the referenced specification, it may be described as soluble or sparingly soluble in water; therefore, the exact solubility statement should be matched to the applicable pharmacopoeial specification.

Appearance: White to off-white crystalline powder

Packaging and Documentation

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

Product Specifications

Product NameLabetalol Hydrochloride API Manufacturer and Supplier in India
CAS Number32780-64-6
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 Labetalol Hydrochloride API Manufacturer and Supplier in India (CAS 32780-64-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Labetalol 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 — Labetalol Hydrochloride API Manufacturer and Supplier in India

What is Labetalol Hydrochloride?
Labetalol Hydrochloride is an adrenergic receptor-blocking pharmaceutical ingredient with both α1-adrenergic and non-selective β-adrenergic blocking activity
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