Active Pharmaceutical Ingredient

Labetalol API Manufacturer and Supplier in India

CAS: 36894-69-6 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Labetalol API Manufacturer and Supplier in India — Mediocon Inc
Labetalol API Manufacturer and Supplier in India

Product Overview

CAS No: 36894-69-6 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Labetalol is an adrenergic receptor-blocking compound with both alpha-1 adrenergic and non-selective beta-adrenergic blocking activity. It is the active moiety of Labetalol Hydrochloride, an established antihypertensive pharmaceutical product.

Labetalol has the molecular formula C₁₉H₂₄N₂O₃ and molecular weight approximately 328.40 g/mol.

Labetalol API

Labetalol is a synthetic salicylamide derivative belonging to the adrenergic receptor antagonist class. Its pharmacological profile combines alpha-1 blockade with non-selective beta blockade, resulting in vasodilation and reduction of cardiovascular sympathetic activity.

The commonly listed CAS number for Labetalol is 36894-69-6.

Chemical Information

Product Name: Labetalol
CAS Number: 36894-69-6
Molecular Formula: C₁₉H₂₄N₂O₃
Molecular Weight: 328.40 g/mol
Chemical Class: Adrenergic receptor antagonist
Therapeutic Class: Antihypertensive / Alpha- and Beta-adrenergic blocker
Parent Salt: Labetalol Hydrochloride
Labetalol Hydrochloride CAS: 32780-64-6
PubChem CID: 3869

PubChem identifies Labetalol as the parent compound and separately identifies its hydrochloride salt.

Mechanism of Action

Labetalol produces its pharmacological effects through competitive alpha-1 adrenergic receptor blockade and non-selective beta-adrenergic receptor blockade.

Alpha-1 blockade contributes to peripheral vasodilation and reduced vascular resistance, while beta blockade reduces sympathetic cardiac activity. The combination contributes to reduction of blood pressure.

Manufacturing and Quality

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

Labetalol 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 is primarily associated with antihypertensive pharmaceutical formulations, generally through its hydrochloride salt form.

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

Product Characteristics

Because pharmaceutical products are commonly supplied as Labetalol Hydrochloride, appearance information for the free-base Labetalol should not be inferred from the hydrochloride specification.

For the hydrochloride salt, official labeling describes the material as a white or almost white powder.

Appearance: Not reliably available / Cannot be verified for the free-base API

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 API Manufacturer and Supplier in India
CAS Number36894-69-6
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
StandardsPharmaceutical Specifications

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 API Manufacturer and Supplier in India (CAS 36894-69-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Labetalol 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 API Manufacturer and Supplier in India

What is Labetalol?
Labetalol is an adrenergic receptor-blocking compound with both alpha-1 and non-selective beta-adrenergic blocking activity.
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