CAS number: 516-54-1

General information about the Brexanolone active pharmaceutical ingredient

Brexanolone as active pharmaceutical ingredient (API) is a synthetic neuroactive steroid gamma-aminobutyric acid A (GABA(a)) receptor positive modulator, indicated for the treatment of postpartum depression (PPD) in adult women. Brexanolone is available as solution. Brexanolone is administered through intravenous (IV) infusion.

Axplora manufactures Brexanolone API

Brexanolone API is manufactured in cGMP by Axplora via chemical synthesis from early stage starting material. Brexanolone 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. Brexanolone 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 Brexanolone API.
  • Therapeutic area CNS
  • Monograph INTERNAL SPEC.
  • Available grade Standard
  • Regulatory documentation US-DMF**
  • Produced in GRO