Maropitant Citrate API

Maropitant Citrate API

CAS No.359875-09-5
Therapeutic CategoryAntiemetic
TechnologySynthetic
Dosage FormOral Solids/Injection
Innovator BrandCerenia(USA)
Registration StatusUS: VMF006413
Others: VMF
PolymorphN/A
GMPFDA(USA)/NMPA(China)/MFDS(Korea) approved
EHSISO 14001 & 45001 certified

Product Description

  • Grade: Active Pharmaceutical Ingredient(API)
  • ChemicalName: (2S,3S)-2-benzhydryl-N-[(5-tert-butyl-2-methoxyphenyl)methyl]-1-azabicyclo[2.2.2]octan-3-amine,2-hydroxypropane-1,2,3-tricarboxylic acid,hydrate
  • Molecular Formula: C17H21FN4
  • Molecular Weight: 300.37400
  • Specification: Enterprise Standard established according to ChP/USP/EP
  • Appearance: Powder
  • Total impurities: not more than 2.0%
  • Purity: not less than 98%
  • 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: Maropitant Citrate
  • Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement

Applications of Maropitant Citrate

  • Maropitant (INN; brand name: Cerenia, used as maropitant citrate (USAN), is a neurokinin-1 (NK1) receptor antagonist developed by Zoetis specifically for the treatment of motion sickness and vomiting in dogs. It was approved by the FDA in 2007, for use in dogs and in 2012, for cats.
  • Maropitant has mild pain-relieving, anti-anxiety, and anti-inflammatory effects.
  • Maropitant citrate injectable solution is indicated for the prevention and treatment of acute vomiting in dogs; maropitant citrate tablets are indicated for the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs. Both are also used extra-label in cats.

Why Choose Us as Your Maropitant Supplier?

  • Qingmu is a Leading Maropitant Manufacturer, DMF in CTD format is available and can be supported for registration worldwide.
  • Our 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.
  • Qingmu’s team has rich experience in patent challenges on crystalline form & synthesis processes, synthetic route development, 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 , Japan, etc. We are committed to producing the best quality products.
  • As a reliable Maropitant factory, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.

FAQ

A1: Negotiate via email→ sign the contract →ship the good

A2: We usually ship the goods by courier, Air, or Sea.

A3: We use Bag, Drum, Carton Box, Alu Tin, etc

A4: We have compliant SOP as per GMP requirement and will be handled according to SOP.

A5: Yes, we’re able to enlarge the batch size if current batch size couldn’t meet your requirement.

A6: