Mirogabalin API

Mirogabalin API

CAS No.1138245-13-2
Therapeutic CategoryAnti-epileptic
Dosage FormOral Solids
Innovator BrandTarlige(USA)
Registration StatusR&D
GMPFDA(USA)/NMPA(China)/MFDS(Korea) approved
EHSISO 14001 & 45001 certified

Product Description

  • Grade: Active Pharmaceutical Ingredient(API)
  • Chemical Name:2-[(1R,5S,6S)-6-(aminomethyl)-3-ethyl-6-bicyclo[3.2.0]hept-3-enyl]acetic acid
  • Molecular Formula: C12H19NO2
  • Molecular Weight: 209.28500
  • 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: R&D
  • Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement

Applications of Mirogabalin API

  • Mirogabalin is a calcium channel blocker with analgesic effects. It binds to the α2δ-1 and α2δ-2 subunits of voltage-dependent Ca2+ channels. Mirogabalin has potent and sustained analgesic effects (ED50 = 2.5 mg/kg) in rats with diabetes induced by streptozotocin (STZ; ). Mirogabalin does not inhibit activities associated with CNS adverse effects of analgesics, such as rotarod performance (ID50 = 9.4 mg/kg) or locomotor activity (ID50 = 43.9 mg/kg), at its effective dose. Formulations containing mirogabalin are in clinical trials for diabetic peripheral neuropathic pain.

Why Choose Us as Your Mirogabalin Manufacturer?

  • Established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, Qingmu’s factory totally complies with environmental law in China, without the risk of relocating factories. 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 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) as well as customer audits from Europe, USA, Japan, etc.
  • As a China Mirogabalin supplier, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.


A1: We have GMP certificate issued by Chinese NMPA, EIR letter issued by USFDA, GMP certificate issued by Korean MFDS, CEP certificate, etc.

A2: Our factory is managed by GMP, we have our own QC lab to test the material and APIs.

A3: It’s needs to discussed as per each product.

A4: Yes. We will gratefully welcome your visit.

A5: Yes. We are looking for distributors and agents all over the world.