Budesonide (API – CAS 5133-22-3 | CEP, ANVISA, KFDA)

Overview

Budesonide is a potent corticosteroid active pharmaceutical ingredient (API) in the Corticosteroid therapeutic category. It is widely used in topical, ophthalmic, oral, and parenteral formulations for its anti-inflammatory and immunosuppressive properties. Manufactured to IP / BP / USP / EP pharmacopoeial standards.

Therapeutic Application

Budesonide is a glucocorticoid used in the maintenance treatment of asthma, COPD, allergic rhinitis, inflammatory bowel disease (Crohn’s disease, ulcerative colitis), and eosinophilic esophagitis.

Specifications

• CAS Number: 5133-22-3
• Appearance: White to off-white crystalline powder
• Typical Assay/Purity: ≥ 99.0%
• Common Pharmacopeial Grades: IP / BP / USP / EP
• Storage: Store in a cool, dry place, away from light
• Shelf Life: Typically 24 months under recommended storage conditions

Regulatory & Compliance

Pharmint Exports adheres to WHO-GMP manufacturing practices, ensuring that Budesonide is produced in compliance with international quality standards. DMF Status: CEP No. R1-CEP 2014-177-Rev 00. Approved regulatory authorities/registrations: ANVISA, KFDA, CDE-NMPA, Patent Granted. Availability of regulatory documents such as USDMF, CEP, and EU-GMP certificates, along with Certificates of Analysis (COA) and Certificates of Suitability (COS), is subject to inquiry.

Packaging & Shipping

Budesonide is packaged in 25kg HDPE drums with double LDPE liners, palletized for secure transport. All necessary export documentation is provided, facilitating shipping to key markets including EU, USA, Brazil, China, South Korea, Taiwan, Middle East.

Common Use Cases & Finished Dosage Forms

This API is typically incorporated into various dosage forms including:

• Tablets
• Capsules
• Injectable solutions

Ordering Information

The minimum order quantity (MOQ) for Budesonide is subject to inquiry. Interested parties are encouraged to request a Certificate of Analysis (COA) and a quote via this listing. For further inquiries, please contact Pharmint Exports directly.