Oclacitinib Maleate API

Oclacitinib Maleate API

CAS No.1208319-27-0
Therapeutic CategoryAntiallergic
TechnologySynthetic
Dosage FormOral Solids
Innovator BrandApoquel(USA)
Registration StatusVMF
PolymorphForm B; Form A
GMPFDA(USA)/NMPA(China)/MFDS(Korea) approved
EHSISO 14001 & 45001 certified

Oclacitinib API (Oclacitinib Maleate API) is a veterinary anti-allergic active pharmaceutical ingredient widely used in companion animal health.

Product Description

  • Grade: Active Pharmaceutical Ingredient(API)
  • Chemical Name: Cyclohexanemethanesulfonamide, N-methyl-4-(methyl-3H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-, trans-, (2Z)-2-butenedioate (1:1)
  • Molecular Formula: C19H27N5O6S
  • Molecular Weight: 453.513
  • Specification: In-house 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 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 Oclacitinib Maleate API

  • #1 Prescribed Oral Medicine for Allergy Relief in Dogs: Fast, effective allergy relief for dogs 12 months and older. Suitable for short-term or long-term use.
  • Stops Allergic Itch at the Source: Not a steroid, antihistamine, or cyclosporine (a drug that reduces immune system activity). Works differently to block allergic itch where it starts.
  • Fast-Acting Relief: Begins working within 4 hours and controls allergic itch within 24 hours to help stop scratching and chewing fast.
  • Can Be Used with Many Other Medications: Compatible with nonsteroidal anti-inflammatory drugs (NSAIDs), vaccines (such as rabies), and allergen-specific immunotherapy. Not evaluated with other systemic immunosuppressants.
  • Available in Three Strengths: 3.6 mg, 5.4 mg, and 16 mg pork-liver flavored chewable tablets. Give once daily with or without food.
  • Apoquel (Oclacitinib Maleate) is an oral chewable tablet that works differently than other skin allergy medications for dogs. It goes straight to the source to help relieve itch and inflammation at its core addressing the underlying cause of irritation and soothing allergic reactions. Apoquel Chewable provides rapid relief from allergic dermatitis and was demonstrated to control allergic pruritus within 24 hrs. Apoquel is ideal for both short or long-term treatment and can help to offer relief without many of the side effects associated with other medications.IMPORTANT SAFETY INFORMATION: Do not use APOQUEL CHEWABLE in dogs less than 12 months of age or those with serious infections. Keep APOQUEL CHEWABLE in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. APOQUEL CHEWABLE may increase the chances of developing serious infections, and may cause existing parasitic skin infestations or pre-existing cancers to get worse. Consider the risks and benefits of treatment in dogs with a history of recurrence of these conditions. New neoplastic conditions (benign and malignant) were observed in clinical studies and post-approval. APOQUEL CHEWABLE has not been tested in dogs receiving some medications including some commonly used to treat skin conditions such as corticosteroids and cyclosporines. Do not use in breeding, pregnant, or lactating dogs. Most common side effects are vomiting and diarrhea. APOQUEL CHEWABLE has been used safely with many common medications including parasiticides, antibiotics and vaccines.

Why Choose Us as Your Oclacitinib Maleate API Manufacturer?

  • Qingmu is an Oclacitinib supplier. DMF in CTD format is available and can be supported for registration worldwide.
  • 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 of removing the 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.
  • Our lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. We passed the site inspection from NMPA(China), FDA(USA), and MFDS(Korea) and also customer audits from Europe, USA, Japan, etc.
  • As an Oclacitinib manufacturer, 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 you with the best quality products and services.

FAQ

A1: We are a manufacturer.

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

A3: It needs to be discussed case by case. You can contact us for detailed information.

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

A5: No, but we’ll give you a quotation according to your order, please email us.

A6: Yes. We are looking for distributors and agents all over the world.