tacrolimus Ointment 0.3 mg, 1 mg - 30 g

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
PICS
Manufacturer #554

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Tacrolimus Manufacturers

Tacrolimus is a quinolone lactone produced from the fermentation process of Streptomyces tsukubaensis bacterium found in a Japanese soil sample. Tacrolimus is a generic pharmaceutical substance that also acts as an immunosuppressive medication used to reduce the risk of organ rejection following an organ transplant. Tacrolimus is also used to treat eczema and psoriasis, as well as severe refractory uveitis following bone marrow transplants, exacerbations of minimum change illness, Kimura's disease, and vitiligo. In 1987, Tacrolimus was found. The FDA approved Tacrolimus for medical use in 1994, and the European Union followed suit in 2002, approving it for the treatment of moderate to severe atopic dermatitis. Opportunistic infection, diabetes mellitus, infection, headache, hyperglycemia, hyperkalemia, increased blood urea nitrogen, increased serum creatinine, mental state changes, nephrotoxicity, sensory disorder, and tremor are some of the most prevalent side effects of taking Tacrolimus stated by the Tacrolimus manufacturers. Tacrolimus is marketed under numerous brand names, including Prograf, which is held by Astellas Pharma, Envarsus XR, which is owned by Veloxis Pharmaceuticals in the United States, and Chiesi in Europe. Protopic is the brand name for the topical formulation sold by LEO Pharma. Tacrolimus is sold under the trade name Prograf, Advagraf, and Protopic among many others. This pharmaceutical medication has the legal status of ''Prescription Only Medication'' and is administered through oral route in form of tablets or capsule, intravenous route in the form of injection, and topical route in the form of ointment or cream. Its pharmacokinetic data reveals its bioavailability to be 24%(5-67%) and less after eating food rich in fats, it is protein binding to be greater or equal to 98.8%. It is metabolized in the liver by CYP3A4 and CYP3A5 and is excreted mostly through the fecal route with the elimination half-life of 11.3 for transplant patients(range 3.5-40.6 hours). Its use during pregnancy is evidenced to be safe in terms of maternal health but the infant may have increased chances of hypertension, preeclampsia, preterm birth, and low birth weight. Associated side effects are increased sensitivity of the skin to hot or cold temperature, itching, acne, infected hair follicles, headache, muscle, or back pain. This pharmaceutical medication interacts with aluminum/magnesium antacids, cyclosporine, sirolimus, temsirolimus, ziprasidone, and water pills such as amiloride and spironolactone. It is contraindicated in patients with conditions like cancer or malignancy, hypomagnesemia, hypocalcemia, hypernatremia, hyponatremia, and high blood pressure. Toxicity of this drug presents with tremors, electrolyte imbalances, headache, increased Serum Creatinine, and acute renal failure. While using this drug close monitoring of serum creatinine, GFR, and urine output is necessary.

How does Tacrolimus work?

It works by the activity of peptidyl-prolyl isomerase by binding to immunophilin FKBP-12(FK506 binding protein) creating a new complex that inhibits both T-lymphocytes signal transduction and IL-2 transcription.

The Wholesale Price of Tacrolimus

The wholesale cost of Tacrolimus medication might vary based on whether it is sold under a brand name or as a generic version, and it also depends on the country. In the United States, a 1 mg Prograf capsule costs around $4.85 per unit, while a 1 mg Tacrolimus capsule costs between $1.99 and $4.64 per capsule. The price of a 0.5 mg Tacrolimus capsule ranges from $1.04 to $1.29, while the price of a 5 mg Tacrolimus capsule ranges from $8.63 to $13.76. Tacrolimus is most commonly available from the European Union, India, Canada, China, Argentina, and South Korea on the Pipelinepharma pharmaceutical market.

Sourcing the Tacrolimus Manufacturers and Suppliers

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Establishing commercial ties

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Quality Assurance

To keep up to the quality standards other than Good Manufacturing Practice approvals that tacrolimus manufacturers list has, we qualify their companies before they are onboarded on the platform. This allows us to screen tacrolimus manufacturers for the quality of the pharmaceutical products’ dossiers and protect against the risk of possible malpractices.