Upadacitinib API

Upadacitinib API

CAS No.1310726-60-3
Therapeutic CategoryAnti-Cancer/ Oncology
TechnologySynthetic
Dosage FormOral Solids
Innovator BrandAbbvie (USA)
Registration StatusR&D
PolymorphTBD
GMPFDA(USA)/NMPA(China)/MFDS(Korea) approved
EHSISO 14001 & 45001 certified

Product Description

  • Grade: Active Pharmaceutical Ingredient(API)
  • Chemical Name: (3S,4R)-3-Ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)-1-pyrrolidinecarboxamide
  • Molecular Formula: C17H19F3N6O
  • Molecular Weight: 380.37
  • 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 Ixazomib Citrate API

  • Upadacitinib is a kind of Human API. Used to treat adult patients with moderate to severe rheumatoid arthritis (RA).
  • Upadacitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
  • Upadacitinib may be used as monotherapy or in combination with methotrexate.

Why Choose Us as Your 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. 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. Please feel free to choose us.
  • 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.
  • As an Upadacitinib manufacturer, 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: