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Respiratory

Budesonide

Pulmicort®

Budesonide is an ICS for maintenance treatment of asthma and prevention of exacerbations. Available as nebulizer suspension and dry powder inhaler.

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Product Details

Dosage FormNebulizer Suspension / DPI Inhaler
Strength0.25 mg/2mL, 0.5 mg/2mL, 1 mg/2mL (nebulizer); 90, 180 mcg (DPI)
StorageStore at 20–25°C upright. Protect from light. Open envelope: use within 2 weeks.
CategoryRespiratory
AvailabilityAvailable for Transfer

Indication

Asthma (maintenance therapy in children and adults); croup (off-label).

Mechanism of Action

Glucocorticoid that activates intracellular glucocorticoid receptors, translocates to the nucleus, and modulates gene transcription to reduce airway inflammation, mucus production, and hyperresponsiveness.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Budesonide 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 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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