CAS number: 82034-46-6

General information about the Loteprednol Etabonate active pharmaceutical ingredient

Loteprednol Etabonate as active pharmaceutical ingredient (API) is a corticosteroid or steroid, class of glucocorticoid indicated in the treatment of pain and inflammation after cataract surgery. Loteprednol Etabonate is used as an antiallergic agent for the treatment of inflammatory and allergic eye conditions. Loteprednol Etabonate can be found as ophthalmic suspension, ointment and gel. Loteprednol Etabonate could be combined with antibiotics where superficial bacterial ocular infection or a risk of bacterial ocular infection might exist.

Axplora manufactures Loteprednol Etabonate API

Loteprednol Etabonate API is manufactured in cGMP by Axplora via chemical synthesis from early stage starting material. Loteprednol Etabonate 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. Loteprednol Etabonate API is also available as sterile product (hyperlink for Loteprednol Etabonate sterile). Loteprednol Etabonate API is commercially available as standard grade specifically designed around various formulation requirements. Tailor-made packaging solutions are available upon request. Feel free to contact us if you need any additional information about Loteprednol Etabonate API.
  • Therapeutic area Ophthalmic
  • Monograph INTERNAL
  • Available grade Standard
  • Regulatory documentation EU DMF
    US DMF
  • Produced in GRO