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Difluprednate
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.
Therapeutic area
Ophthalmic
Monograph
- INTERNAL
- SPEC.
Available grade
Micronized
Regulatory documentation
- EU DMF
- JP DMF
- US DMF**
Produced in
GRO
Product Category
Steroids
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.
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