CAS number: 23674-86-4

General information about the Difluprednate active pharmaceutical ingredient

Difluprednate as active pharmaceutical ingredient (API) is a corticosteroid or steroid, class of glucocorticoid used as an anti-inflammatory steroidal drug used primarily in ocular surgery. Difluprednate is used to treat eye pain, redness, and swelling caused by eye surgery or endogenous anterior uveitis. Difluprednate can be found as eye drops and emulsion for ophthalmic uses.

Axplora manufactures Difluprednate API

Difluprednate API is manufactured in cGMP by Axplora via chemical synthesis from early stage starting material. Difluprednate 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. Difluprednate API is commercially available as micronized 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 Difluprednate API.
  • Therapeutic area Ophthalmic
  • Monograph INTERNAL
  • Available grade Micronized
  • Regulatory documentation EU DMF
    US DMF#
    JP DMF
  • Produced in GRO