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1. Januvia : EPAR - Scientific Discussion

Quality aspects. Introduction. Januvia is presented as film-coated tablets
containing 25 mg, 50 mg and 100 mg of Sitagliptin (as monohydrate Phosphate
salt) as active substance. The other ingredients are microcrystalline cellulose,
dibasic calcium phosphate, croscamellose sodium, magnesium stearate and
sodium stearyl ...
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2. Sitagliptin Phosphate - FDA

Contains Nonbinding Recommendations. Draft Guidance on Sitagliptin
Phosphate. This draft guidance, once finalized, will represent the Food and Drug
Administration's (FDA's) current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the public.
You can ...
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3. Sitagliptin Phosphate Monohydrate Ep Monograph - E-Marefa

Page 1.
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4. workshop finished product monographs - EDQM

Oct 8, 2014 ... 1 monograph on a single-source product, Sitagliptin phosphate monohydrate
tablets (active substance still under patent protection). – 1 monograph on a multi-
source product, Clopidogrel hydrogen sulphate tablets (broad range of finished
product from different manufacturers on the European market).
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