Formoterol API Manufacturer & Supplier in India

Formoterol is a long-acting selective beta-2 adrenoceptor agonist used as a bronchodilator in the management of asthma and chronic obstructive pulmonary disease (COPD). Its rapid onset and long duration (12+ hours) make it effective for both acute relief and maintenance therapy.

Mediocon Inc supplies Formoterol IP/BP/USP as a pharmaceutical-grade active ingredient for respiratory drug manufacturers producing inhaled and oral formulations. Our GMP-compliant Formoterol meets strict pharmacopoeial requirements with full documentation support.

Key Features

• Long-acting beta-2 agonist (LABA)
• Rapid onset with 12+ hour duration
• Suitable for inhalation & oral dosage forms
• Full regulatory documentation support

Applications

• Asthma maintenance therapy (DPI/MDI formulations)
• COPD bronchodilator formulations
• Combination inhalers with corticosteroids
• Respiratory pharmaceutical manufacturing

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

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Formoterol (CAS 73573-87-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Formoterol 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