Mirogabalin API

CAS No.	1138245-13-2
Therapeutic Category	Anti-epileptic
Technology	Synthetic
Dosage Form	Oral Solids
Innovator Brand	Tarlige(USA)
Registration Status	R&D
Polymorph	N/A
GMP	FDA(USA)/NMPA(China)/MFDS(Korea) approved
EHS	ISO 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

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.

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.