Etoricoxib API

Etoricoxib API

CAS No.202409-33-4
Therapeutic CategoryAnti-inflammatory
TechnologySynthetic
Dosage FormOral Solids
Innovator BrandArcoxia(USA)
Registration StatusDMF
PolymorphForm I
GMPFDA(USA)/NMPA(China)/MFDS(Korea) approved
EHSISO 14001 & 45001 certified

Product Description

  • Grade: Active Pharmaceutical Ingredient(API)
  • Chemical Name: 5-Chloro-6′-methyl-3-[4-(methylsulfonyl) phenyl]-2,3′-bipyridine
  • Molecular Formula: C18H15ClN2O2S
  • Molecular Weight: 358.84
  • Specification: In-house 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 or milling/sieving according to customer’s requirement.
  • Storage: Room temperature
  • Production capacity: Commercial
  • Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement

Applications of Etoroxib API

Etoricoxib Tablets (Arcoxia) Indications:

  • Treatment of the signs and symptoms of osteoarthritis (OA).
  • Relief of acute gouty arthritis.
  • Management of primary dysmenorrhea.

Why Choose Us as Your Etoricoxib API Manufacturer?

  • 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.
  • Qingmu’s team has rich experience in patent challenges on crystalline form & synthesis processes and also synthetic route development and scale-up & quality research.
  • As a Etoricoxib manufacturer, 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. We are always ready to provide customers with the best quality products and services.

FAQ

A1: Yes if it’s listed on Pharmacopopeia, if not, we’ll establish our own standard according to USP/EP/JP/ChP

A2: One standard package during the commercial stage, but a sub-package can be arranged to support your development.

A3: Yes, it can be discussed.

A4: We support T/T, L/C, and DP.

A5: You can receive our reply within 24 hours if your inquiry was sent in working hours.

A6: Yes, we’re able to enlarge the batch size if current batch size couldn’t meet your requirement.