Brexpiprazole API

Brexpiprazole API

CAS No.913611-97-9
Therapeutic CategoryNeurology & Psychiatry
TechnologySynthetic
Dosage FormOral Solids
Innovator BrandRexulti(USA)
Registration StatusChina: I
Others: DMF
PolymorphAnhydrous
GMPFDA(USA)/NMPA(China)/MFDS(Korea) approved
EHSISO 14001 & 45001 certified

Product Description

  • Grade: Active Pharmaceutical Ingredient(API)
  • Chemical Name:7-[4-[4-(1-benzothiophen-4-yl)piperazin-1-yl]butoxy]-1H-quinolin-2-one
  • Molecular Formula:C25H27N3O2S
  • Molecular Weight:433.566
  • Specification: Enterprise Standard established according to ChP/USP/EP
  • Appearance: Powder
  • Total impurities: not more than 0.5%
  • Purity: not less than 99%
  • Residual Solvents: fully comply with ICH Q3C
  • Mutagenic impurities: fully comply with ICH M8
  • Nitrosamine assessment: available
  • Particle size: regular grade and micronized(D90<10μm)
  • Storage: Room temperature
  • Production capacity: Commercial
  • Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement

Applications of Brexpiprazole

  • Brexpiprazole is an atypical antipsychotic and a novel D2 dopamine and serotonin 1A partial agonist called serotonin-dopamine activity modulator (SDAM). It has a high affinity for serotonin, dopamine, and alpha (α)-adrenergic receptors. Although it is structurally similar to aripiprazole, brexpiprazole has different binding affinities for dopamine and serotonin receptors. Compared to aripiprazole, brexpiprazole has less potential for partial agonist-mediated adverse effects such as extrapyramidal symptoms, which is attributed to lower intrinsic activity at the D2 receptor. It also displays stronger antagonism at the 5-HT1A and 5-HT2A receptors.
  • Brexpiprazole was first approved by the FDA on July 10, 2015. Currently approved for the treatment of depression, schizophrenia, and agitation associated with dementia due to Alzheimer’s disease, brexpiprazole has also been investigated in other psychiatric disorders, such as post-traumatic stress disorder.

Why Choose Us as Your Manufacturer?

  • Qingmu’s Brexpiprazole has been filed in China(DMF filed and listed on CDE’s website), DMF in CTD format is available and can be supported for registration worldwide.
  • Qingmu’s factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, no risk to remove factory. A new API factory is under design and is predicted to be put into use in 2025.
  • As a China Brexpiprazole manufacturer, Qingmu’s team has rich experience in patent challenges on crystalline form & synthesis processes and also synthetic route development and scale-up & quality research.
  • Qingmu’s lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. Qingmu passed the site inspection from NMPA(China), FDA(USA) and MFDS(Korea) and also customer audits from Europe, USA and Japan, etc.
  • Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil. So please feel free to choose us.

FAQ

A1: We are a manufacturer.

A2: No, but we’ll give you a quotation according to your order, please email us.

A3: One standard package during the commercial stage, but a sub-package can be arranged to support your development.

A4: We use Bags, Drums, Carton Boxes, Alu Tin, etc.

A5: Yes if it’s listed on Pharmacopopeia, if not, we’ll establish our own standard according to USP/EP/JP/ChP

A6: