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Respiratory

Budesonide / Formoterol

Symbicort®

Budesonide/Formoterol is an ICS/LABA combination for asthma and COPD. Also approved for as-needed use (SMART approach) in asthma management.

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Product Details

Dosage FormInhaler (MDI / DPI)
Strength80/4.5, 160/4.5, 320/9 mcg
StorageStore at 20–25°C.
CategoryRespiratory
AvailabilityAvailable for Transfer

Indication

Asthma (maintenance and reliever therapy); COPD (maintenance treatment to reduce exacerbations).

Mechanism of Action

Budesonide (ICS) suppresses inflammation through glucocorticoid receptor activation. Formoterol (LABA) provides rapid and sustained bronchodilation via beta-2 receptor stimulation.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Budesonide / Formoterol includes comprehensive documentation and support:

Master Formula

Complete formulation with manufacturing parameters, excipient specifications, and process controls.

Analytical Methods

Validated methods for assay, impurities, dissolution, and stability-indicating analysis.

CTD/eCTD Templates

Market-ready regulatory dossier templates — available through Burrard Intelligence subscription.

Stability Data

ICH-compliant stability studies (accelerated and long-term) with detailed protocols.

Manufacturing Protocols

Scale-up procedures, batch records, equipment specifications, and in-process controls.

Expert Support

Direct advisory access to formulation scientists and regulatory specialists throughout transfer.

Ready for Budesonide / Formoterol Technology Transfer?

Our team can deliver the complete know-how package within 2–21 business days. Book a consultation to discuss your specific requirements.

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