Sitagliptin Phosphate Monohydrate Ep Monograph - E-Marefa

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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 Draft Guidance on Sitagliptin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 This draft guidance, once finalized, will represent the Food and Drug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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1. Anticipated Availability of First-Time Generics - the enhanced site

Oct 3, 2017 ... PharmacistsLetter.com ~ PrescribersLetter.com ~ PharmacyTechniciansLetter.
com ~ NursesLetter.com. Branda. (Manufacturer). Generic Name. Generic
Manufacturer(s)b,1. Anticipated Availabilityc. Januvia. (Merck). Sitagliptin. Apotex
, Mylan, Sandoz, Sun, Teva. July 2022 (or earlierd)21,124. Toviaz.
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2. Buy sitagliptin phosphate without prescription

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3. Chemistry Review(s) - FDA

Oct 16, 2006 ... CHEMISTRY REVIEW. NDA 21-995. J anuviaTM (sitagliptin phosphate) Tablets.
Merck And Co., Inc. Stephen Moore, PhD. Christine Moore, Ph.D. Vibhakar Shah,
Ph.D. ONDQA/ DPA I DMEP ...
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4. CONTENTS OF SUPPLEMENT 8.7

Apr 1, 2016 ... Subscribers to the current version (printed or electronic) of the European
Pharmacopoeia have access to an archive version of all previous editions of the
... The texts below appear for the first time in the European Pharmacopoeia. They
will be ... Sitagliptin phosphate monohydrate (2778). Sitagliptin tablets ...
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5. CONTENTS OF SUPPLEMENT 8.7

Apr 1, 2016 ... Subscribers to the current version (printed or electronic) of the European
Pharmacopoeia have access to an archive version of all previous editions of the
... The texts below appear for the first time in the European Pharmacopoeia. They
will be ... Sitagliptin phosphate monohydrate (2778). Sitagliptin tablets ...
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6. CPY Document Title - FDA

Mar 4, 2007 ... Sitagliptin phosphate menohydrate has a chemical name is 7-[(3R)- ... Sitagliptin
phosphate monohydrate is a white to off-white solid, melting point ' '°C, and. 'a
pKa of V According to the Biopharmaceutics classification ... These specifications
comply with the USP monograph for metformin hydrochloride.
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7. CPY Document Title - FDA

Mar 4, 2007 ... phosphate monohydrate is a white to off-white solid, melting point ' '°C, and. 'a
pKa of V According to the Biopharmaceutics classification system (BCS).
Sitagliptin is a Class III (high solubility, low permeability)/borderline Class I (high
solubility, high permeability) drug. Sitagliptin phosphate monohydrate is ...
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8. Data Sheet - Medsafe

JANUVIA® 100 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE
COMPOSITION. Each JANUVIA 25 mg tablet contains sitagliptin phosphate
monohydrate, equivalent to 25 mg sitagliptin. Each JANUVIA 50 mg tablet
contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin. Each
JANUVIA ...
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9. edqm: 50 years of leadership in the quality of medicines paving the

Oct 8, 2014 ... Pharmacopoeias, such as the USP, but also by pharmacopoeias from European
Pharmacopoeia ... one single-source (Sitagliptin Phosphate tablets) and one
multi-source product (Clopidogrel Tablets) ... product, Sitagliptin phosphate
monohydrate tablets (active substance still under patent protection).
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10. formulation and evaluation of sitagliptin phosphate and - eJManager

Sep 11, 2015 ... formulations of sitagliptin phosphate and simvastatin bilayered tablets were
prepared by varying the ratios of polymers in the sitagliptin phosphate layer and
simvastatin layer F1 to. F10 by direct compression method. FTIR studies revealed
there is no interaction between the drugs i.e., sitagliptin phosphate ...
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