Active Pharmaceutical Ingredient

Salbutamol API Manufacturer & Bulk Supplier in India | MEDIOCON INC

CAS: 18559-94-9 Active Pharmaceutical Ingredient USP / BP / EP / IP GMP Certified Aurangabad, Maharashtra, India
Salbutamol API Manufacturer & Bulk Supplier in India | MEDIOCON INC — Mediocon Inc
Salbutamol API Manufacturer & Bulk Supplier in India | MEDIOCON INC

Product Overview

CAS No: 18559-94-9 | Grade: USP / BP / EP / IP | Category: Active Pharmaceutical Ingredient

Salbutamol API Manufacturer & Bulk Supplier

Salbutamol API (also known as Albuterol API) is a premium-quality pharmaceutical-grade Active Pharmaceutical Ingredient (API) widely used in the formulation of bronchodilator medications for the treatment and prevention of asthma, chronic obstructive pulmonary disease (COPD), bronchospasm, and other respiratory disorders. As a selective β₂-adrenergic receptor agonist, Salbutamol relaxes bronchial smooth muscles, providing rapid relief from airway obstruction and improving respiratory function. Its high purity, excellent stability, and consistent batch quality make it ideal for pharmaceutical formulation development, analytical testing, quality control, stability studies, and authorized pharmaceutical research.

MEDIOCON INC is a trusted Salbutamol API manufacturer and bulk supplier in India, supplying premium-quality pharmaceutical ingredients to pharmaceutical companies, inhalation product manufacturers, biotechnology organizations, contract manufacturing organizations (CMOs), formulation developers, research laboratories, and international distributors. Our GMP-compliant manufacturing facilities employ advanced production technologies and stringent quality management systems to ensure superior purity, consistency, and compliance with international pharmaceutical standards.

Every batch of Salbutamol API manufactured by MEDIOCON INC undergoes comprehensive analytical testing using validated quality control methods. Critical quality parameters including identity, assay, impurity profile, moisture content, pH, melting point, specific rotation, residual solvents, particle size distribution, heavy metals, and stability are carefully evaluated before commercial release to ensure compliance with stringent pharmaceutical quality specifications.

Our Salbutamol API is available in USP, BP, EP, IP, and Pharmaceutical Grade, making it suitable for inhalation formulations, tablets, syrups, injections, nebulizer solutions, dry powder inhalers (DPIs), metered-dose inhalers (MDIs), analytical testing, formulation development, quality control laboratories, stability studies, and pharmaceutical process validation. We also provide complete regulatory documentation, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and supporting regulatory documents, ensuring seamless procurement and regulatory compliance.

With a strong commitment to quality, innovation, and customer satisfaction, MEDIOCON INC has established itself as a dependable global supplier of pharmaceutical raw materials. Through secure packaging, competitive pricing, efficient logistics, and dedicated technical support, we ensure reliable worldwide delivery of premium-quality Salbutamol API.

If you are looking for a reliable Salbutamol API manufacturer, exporter, and bulk supplier, MEDIOCON INC offers pharmaceutical-grade ingredients backed by complete documentation, consistent quality, and timely worldwide supply.

Product Specifications

Product NameSalbutamol API Manufacturer & Bulk Supplier in India | MEDIOCON INC
CAS Number18559-94-9
CategoryActive Pharmaceutical Ingredient
GradeUSP / BP / EP / IP
AppearanceWhite to Off-White Crystalline Powder
StandardsUSP / BP / EP / IP

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR, UV & HPLC Complies
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 0.5%
Residue on IgnitionNMT 0.1%
Heavy MetalsNMT 0.2%
pH (1% Solution)3.5 – 5.5
Individual ImpurityNMT 0.5%
Total ImpuritiesNMT 1.0%
Water ContentNMT 1.0%
Specific Rotation−0.5° to +0.5° (Racemic Mixture)
Melting Point155°C – 160°C
SolubilityFreely Soluble in Water; Slightly Soluble in Ethanol; Soluble in Methanol

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 Salbutamol API Manufacturer & Bulk Supplier in India | MEDIOCON INC (CAS 18559-94-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Salbutamol API Manufacturer & Bulk Supplier in India | MEDIOCON INC 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 — Salbutamol API Manufacturer & Bulk Supplier in India | MEDIOCON INC

What is Salbutamol API used for?
Salbutamol API is used in the manufacture of bronchodilator medications for the treatment and prevention of asthma, COPD, bronchospasm, and other respiratory disorders.
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