CAS number: 51333-22-3

General information about the Budesonide active pharmaceutical ingredient

Budesonide as active pharmaceutical ingredient (API) is a corticosteroid or steroid, class of glucorticoid, used in the management of asthma and other chronic obstructive pulmonary diseases (COPD), the treatment of various skin disorders, allergic rhinitis, and ulcerative colitis. It works by preventing inflammation in the lungs, which makes the asthma attack less severe. Inhaled budesonide may be used with other asthma medicines such as bronchodilators, which are also used to open narrowed breathing passages in the lungs. Budesonide is used to treat Crohn’s disease, an inflammatory bowel disease: this medicine works inside the intestines to reduce inflammation and symptoms of the disease. It also helps keep the symptoms of Crohn’s disease from coming back. Budesonide extended-release tablets and rectal foams are used to help get ulcerative colitis under control. Budesonide nasal spray is used to treat cold-like symptoms caused by allergic rhinitis.

Axplora manufactures Budesonide API

Budesonide API is manufactured in cGMP by Axplora via chemical synthesis from early stage starting material. Budesonide API is produced by Farmabios, our EUGMP, USFDA and PMDA approved manufacturing site with legal seat in Gropello Cairoli, Italy. Farmabios’ expertise is to make and handle with steroids, niche hormones, and highly potent active pharmaceutical ingredient (HPAPI), including cytotoxic drugs. Budesonide API is commercially available in multiple micronized grades specifically designed around various formulation requirements. Budesonide API customized particle size distribution (PSD) grades, including post milling conditioning, and tailor-made packaging solutions are available upon request. Feel free to contact us if you need any additional information about Budesonide API.
  • Therapeutic area Respiratory
  • Monograph PH.EUR.
  • Available grade Micronized
  • Regulatory documentation US DMF#
    JP DMF
  • Produced in GRO