ustekinumab Injection 45 mg, 90 mg, 130 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
FDA, EU GMP, MHRA, Canada, Switzerland
Comments
Ref. Stelara
Manufacturer #33698

Established in 1999, this manufacturer specializes in providing integrated strategy, execution, and innovation services for healthcare and life sciences companies. As a CTD dossier owner and manufacturer, it ensures compliance with international quality standards. The manufacturer operates advanced production lines adhering to stringent GMP guidelines.

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Ustekinumab Manufacturers

Ustekinumab is a human immunoglobin (Ig) monoclonal antibody belongs to a class of drugs called as monoclonal antibodies. This medication is used to treat moderate to severe plaque psoriasis (a type of skin disease in which red, scaly patches form on some areas of the body) in adults and children aged 6 and above who may benefit from phototherapy or systemic therapy (a treatment that involves exposure of skin to ultraviolet light). This drug is also used alone or sometimes in combination with other drugs for the management of active psoriatic arthritis in adults. Ustekinumab is also used to treat Crohn’s disease, Ulcerative colitis in adults. This medication is advised as a prescription product and issued only on physician’s prescription. Ustekinumab is marketed by manufacturers under the Brand name of Stelara, Stelara PFS (Prefilled Syringe). Ustekinumab is available in the dosage form of Injection (liquid), for intravenous or subcutaneous administration. There is no pill form of Ustekinumab. The available dosage strength of Ustekinumab is 5 mg/mL, 45 mg / 0.5 mL, 90 mg / mL solution. Each prefilled syringe or vial is for single use only and do not shake a syringe or vial that contains Ustekinumab. The recommended adult subcutaneous dosage for psoriatic arthritis and plaque psoriasis is 45 mg administered subcutaneously initially and after 4 weeks, then 45 mg subcutaneously for every 12 weeks. And for acute crohn’s disease, the dosing depends on the patient’s weight. Ustekinumab is not recommended for pediatric patients below 6 years of age as safety and efficacy have not been established. Until the first usage, Ustekinumab Vials and Syringes should be kept in the original carton to protect from light. Ustekinumab vial and prefilled syringe must be refrigerated at 2° C - 8° C (36° F - 46° F). The vials should be stored in upright position. Do not shake and freeze.

Wholesale Price of Ustekinumab

The cost for Ustekinumab intravenous solution (5 mg/mL) is around $1,762 for a supply of 26 milliliters with per unit cost comes at $ 67.76 The wholesale price of 45 mg / 0.5 mL Ustekinumab subcutaneous solution is around $ 12,058.74 for a supply of 0.5 milliliters. The cost for Ustekinumab subcutaneous solution (90 mg / mL) is around $ 24,107.99 for a supply of 1 milliliter. Ustekinumab is categorized under patient assistance programs where the medication is sponsored by pharmaceutical companies where the drug is provided for free or at discounted rates to low income or underinsured people who meet the eligibility criteria.

Ustekinumab - Mechanism of Action

Interleukin (IL)-12 and IL-23 cytokines are the natural proteins in the body which are involved in inflammatory and immune responses such as natural killer cell activation and T helper cell differentiation and activation. Ustekinumab binds to the p40 protein subunit used by IL-12 and IL-23 cytokines and exhibits its action by blocking these natural proteins IL-12 and IL-23 cytokines that cause inflammation (swelling) in psoriatic arthritis, ulcerative colitis.

Finding Ustekinumab Manufacturers and Suppliers

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