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Letrozole is a non-steroidal oral aromatase inhibitor. It is used to treat advanced breast cancer in postmenopausal women and is used for the initial or extended adjuvant treatment of hormone-receptor positive early breast cancer in postmenopausal women. It is also used off-label for the treatment of infertility. Unlike aminoglutethimide, an early aromatase inhibitor, letrozole does not inhibit adrenal steroid synthesis. Aromatase inhibitors are considered to be a standard of therapy and drug class of choice for the treatment of early breast cancer in postmenopausal women with hormone-receptor positive disease.
Letrozole’s innovator is Novartis-Global and appears world-wide under the brand name Femara.
Letrozole inhibits aromatase, the enzyme that catalyzes the final step in estrogen production. Letrozole competitively binds to the heme of the cytochrome P450 subunit of aromatase. Actions in post-menopausal women: In postmenopausal women, the principal source of circulating estrogens is from the conversion of adrenal and ovarian androgens (androstenedione and testosterone) to estrogens (estrone and estradiol) by aromatase in peripheral tissues. Inhibition of aromatase may result in a more complete estrogen block than surgical ablation. Extraglandular sites are more amenable to aromatase inhibition by letrozole than are premenopausal ovaries. Inhibiting the biosynthesis of estrogens is one way to deprive the tumor of estrogens and to restrict tumor growth. Actions in pre-menopausal women -ovarian stimulation: Normally, through negative feedback, estrogens decrease the release of FSH from the pituitary gland; it is hypothesized that by blocking estradiol production through inhibiting aromatase, letrozole may increase the release of FSH and induce ovulation. It is also theorized that the androgens, which would normally be converted to estrogens, may accumulate in the ovaries thereby increasing the senstivity of ovarian follicles to FSH.
Letrozole appears in the following formulation and dosage: Tablets: 2.5 mg
General data on Letrozole Active Pharmaceutical Ingredient
USP 30: Letrozole is a white to yellowish, crystalline powder. Letrozole is practically insoluble in water; slightly soluble in alcohol; freely soluble in dichloromethane.
TAPI's Letrozole Pharmaceutical Ingredient
TAPI's Letrozole Active Pharmaceutical Ingredient is produced in Sicor de Mexico S.A. de C.V. in Lerma Estado de Mexico, Mexico.
Letrozole is a highly potent active pharmaceutical ingredient. Letrozole belongs to the hormone contraceptive and replacement therapy group of drugs. These drugs are highly potent active pharmaceutical ingredients that need special handle in production or preparation. As a highly potent drug, Letrozole is considered to be small volume Active Pharmaceutical Ingredient.
TAPI provides full service on Letrozole and other APIs in our portfolio. We provide information on TAPI's Letrozole, the regulatory compliance with various health regulations and documentation. Contact us today for further inquiries and samples and kilograms availability information for TAPI's Letrozole.
2008 Available DMF: U.S. DMF and Open EU CTD.
TAPI is a world leading developer and manufacturer of highly potent drugs used by innovative and generic companies to formulate their final dosage medications. TAPI highly potent manufacturing plants are located mainly in Italy (Sicor S.r.l. ) and Mexico (Sicor de Mexico) . TAPI highly potent active pharmaceutical ingredients, such as Letrozole, are used in oral, parenteral, topical and inhalation therapies; and most fall in four classes: Steroids, Oncolytics, Hormones, Non-depolarizing muscle relaxants, Immunosuppressants.
Contact us today for information on TAPI's Letrozole and other highly potent Active Pharmaceutical Ingredients.
TAPI’s Letrozole has unique features that might be advantage for final dosage development. TAPI has filled several patent applications for Letrozole. Please, see table below for issued patents and pending applications.
Legal Note
Product exploitation, including development, sales and offer for sale are performed where permissible by patent law. This presentation is not and should not constitute an offer for sale in territories where it is not permitted by law. In USA Products that Currently on Patent are available for R&D Use in Accordance with 35 USC §271 (e) (1).
*TAPI stands for Teva's Active Pharmaceutical Ingredients
