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Loteprednol Etabonate

General information about the Loteprednol Etabonate sterile active pharmaceutical ingredient

Loteprednol Etabonate sterile as active pharmaceutical ingredient (API) is a corticosteroid or steroid, class of glucocorticoid used to treat certain eye conditions due to inflammation or injury, and it is also used after eye surger. Loteprednol Etabonate sterile is also indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. Loteprednol Etabonate sterile could be combined with antibiotics where superficial bacterial ocular infection or a risk of bacterial ocular infection might exist. Loteprednol Etabonate sterile come as ophthalmic suspension, gels and creams.

Therapeutic area

Ophthalmic

Monograph

  • INTERNAL
  • SPEC.

Available grade

Micronized

Regulatory documentation

  • EU DMF
  • US DMF**

Produced in

GRO

Product Category

Sterile Steroids

Axplora manufactures Loteprednol Etabonate sterile API

Loteprednol Etabonate sterile API is manufactured in cGMP by Axplora via chemical synthesis from early stage starting material. Loteprednol Etabonate sterile 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 sterile API is sterilized by aseptic filtration. Loteprednol Etabonate sterile 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 Loteprednol Etabonate sterile API.

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