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Brexanolone
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.
Therapeutic area
CNS
Monograph
INTERNAL SPEC.
Available grade
Standard
Regulatory documentation
US DMF**
Produced in
GRO
Product Category
Steroids
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.
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