In 2001, FDA published the ICH guidance for industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.8 ICH Q7 represents FDA’s current thinking on CGMP for APIs. Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor. A comprehensive alphabetical list of over-the-counter ingredients provided by the FDA. Note: This table was originally prepared by Dr. Alan York, North Carolina State University and was updated by Drs. Eric Prostko, Stanley Culpepper, Tim Murphy, and Patrick McCullough, The University of Georgia, September 2009. FDA generally defines active moiety as the core molecule or ion of a drug (i.e., the drug molecule without certain appendages) that is “responsible for the physiological or pharmacological action of a drug substance.” FDA generally defines active moiety as the core molecule or ion of a drug (i.e., the drug molecule without certain appendages) that is “responsible for the physiological or pharmacological action of a drug substance.” Inactive ingredients colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, triacetin and titanium dioxide. Rev. 11/07 Mfd.