How to Source Albuterol+Budesonide for Pharmaceutical Formulation
Albuterol+Budesonide (Inhalation, 90mcg+80mcg) is classified under Respiratory Disorder. It is therapeutically aligned with reference brands such as Airsupra (USA). This guide highlights key sourcing factors buyers should consider when procuring high-quality Albuterol+Budesonide for formulation, R&D, or bulk manufacturing.
Product Overview:
Albuterol/Budesonide is a combination inhaler used to manage and prevent asthma and other chronic respiratory conditions. Albuterol is a short-acting β₂-agonist (SABA) that provides quick relief from bronchospasm by relaxing the airway muscles, while Budesonide is an inhaled corticosteroid (ICS) that reduces airway inflammation and prevents asthma attacks. This combination can be used as-needed for immediate relief (in products like Airsupra) or as maintenance therapy (in products like Symbicort or DuoResp) depending on the formulation. It helps improve breathing, reduce wheezing, and lower the frequency of asthma exacerbations.
1. Regulatory Compliance & Documentation
Ensure suppliers provide:
- ✔ Valid DMF (Drug Master File)
- ✔ COA (Certificate of Analysis) for each batch
- ✔ GMP, ISO, or ICH Q7 compliance certificates
2. Purity, Grade & Specification Matching
Albuterol+Budesonide must meet exact grade and purity for your dosage form:
- ✔ USP / EP / JP grade verification
- ✔ Particle size distribution check
- ✔ Residual solvent and heavy metal limits
3. Supplier Reliability & Audit History
- ✔ Positive past audit reports
- ✔ Pharma client references
- ✔ Years of proven API manufacturing experience
4. Commercial Terms: Pricing, MOQ & Flexibility
- ✔ Transparent pricing
- ✔ Pilot batch MOQ flexibility
- ✔ Volume-based discounts
5. Lead Time, Inventory & Logistics
Typical lead time for Albuterol+Budesonide is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Conclusion
Sourcing Albuterol+Budesonide is more than procurement—it’s a strategic partnership. With its inhalation form and 90mcg+80mcg specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.
Next Step: Get expert assistance in sourcing Albuterol+Budesonide.
Frequently Asked Questions For Sourcing of Albuterol+Budesonide
What is the typical lead time for Albuterol+Budesonide?
Lead times range from 4–6 weeks depending on supplier and region.
Is Albuterol+Budesonide available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Albuterol+Budesonide require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Albuterol+Budesonide?
Yes, a DMF is available for regulated markets upon request. It includes detailed quality, manufacturing, and stability data.
Can I request samples or a pilot batch of Albuterol+Budesonide?
Yes — pilot batches or samples can be arranged for R&D, stability studies, or formulation trials. MOQ may vary based on region and regulatory scope.
What compliance certificates are available for Albuterol+Budesonide?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Albuterol+Budesonide suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Albuterol+Budesonide be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.