Budesonide (Oral & Respiratory) API

Budesonide API (Oral & Respiratory grades) has been developed at Minakem’s French facility in Dunkerque (formerly AstraZeneca’s legacy facility) for over 20 years.
Budesonide API CAS number is 51333-22-3.

From a regulatory perspective, Minakem offers:
– An American DMF (Drug Master File) #28441
– A European DMF (CEP 2010-90)
– A Japanese DMF #301MF10045
– A Chinese DMF #Y20180001668
– An Indonesian DMF

Minakem’s Budesonide API brings:
– Annual production capacity over 10 MT;
– Selective granulometry (PSD) to facilitate your formulation, mainly for inhalation applications;
– High-quality production standards.

Therapeutical Class and Mechanism of Action
Budesonide API is a corticosteroid that belongs to the class of glucocorticoids. It is commonly used as an anti-inflammatory agent in the treatment of various conditions, particularly for respiratory diseases and gastrointestinal disorders.
Budesonide works primarily by exerting anti-inflammatory and immunosuppressive effects through the following mechanisms:
• Glucocorticoid Receptor Activation
• Gene Transcription Modulation
• Reduction of Inflammatory Mediators
• Immune Suppression

About Minakem Dunkerque Expertise
Minakem Dunkerque has been manufacturing Active Pharmaceutical Ingredients (APIs) for over 30 years. The site, formerly AstraZeneca’s legacy API facility, is dedicated to the production of esomeprazole, omeprazole, and budesonide APIs.
The site has extensive expertise in manufacturing large quantities of APIs and micronizing them. It also manufactures corticosteroids, including Budesonide API.
Strategically located in the heart of Europe, near the Dunkerque and Antwerpen harbors, the site exports more than 50% of its production globally.

About Minakem’s Network
Minakem Dunkerque collaborates daily with Minakem’s other European facilities and with Minakem Montreal, leveraging their complementary expertises in solid engineering, analytics, global regulatory affairs, and other capabilities to enhance competitiveness.
Minakem brings over 40 years of experience in developing, scaling up, registering Drug Master Files (DMFs), and manufacturing complex Active Pharmaceutical Ingredients (APIs), including chiral small molecules, steroids, and highly potent APIs (HPAPIs)—primarily used in oncology treatments.
As supply chain performance becomes increasingly critical to customers’ success, Minakem focuses on delivering:
• Safe products for patients,
• High On-Time-In-Full (OTIF) performance,
• Robust quality support, and
• Innovative solutions to address customers’ unexpected market demands.

More data on Budesonide API
Budesonide Dihydrate’s data are avilable on Pharmaoffer.

Budesonide additional data are available on Wikipedia