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Ximelagatran
Ximelagatran 192939-46-1, EXANTA N-[(1R)-1-cyclohexyl-2-[(2S)-2-[[[[4-[(hydroxyamino)iminomethyl]phenyl]methyl]amino]carbonyl]-1-azetidinyl]-2-oxoethyl]-glycine, ethyl ester C24H35N5O5...
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How to become a QP for Europe
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of...
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How to document a Product Transfer? Example templates!
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: All participants of the GMP training course “GMP-compliant Product Transfer” will receive a special version of the Guideline Manager CD...
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Lemborexant
Lemborexant E2006 CAS Number: 1369764-02-2 MF C22 H20 F2 N4 O2 MW 410.42 Chemical Name: (1R, 2S) -2 – {[(2,4-dimethylpyrimidin-5-yl) oxy] methyl} -2- (3-fluorophenyl ) N (5-fluoropyridin-2-yl)...
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DABIGATRAN PART 2/3
Dabigatran etexilate (a compound of formula (I)) is the international commonly accepted non-proprietary name for ethyl...
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Vandetanib
Vandetanib; 443913-73-3; Zactima; ZD6474; Caprelsa; ZD 6474; ch 331, azd 6474 cas 338992-00-0 free form 338992-48-6 HCl 338992-53-3 monotrifluoroacetate...
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Indian pharma’s struggle to tighten standards paves way for M&A deals
People walk past a chemist shop at a market in Mumbai. Photo: Reuters MUMBAI – India’s smaller generic drugmakers, struggling to cope with a bruised reputation and tougher regulation in the United...
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WO 2015129603, NEW PATENT, Daiichi Sankyo Co Ltd, Edoxaban
WO 2015129603 HIGH-PURITY CRYSTALS OF ACTIVE BLOOD COAGULATION FACTOR X (FXA) INHIBITOR DAIICHI SANKYO COMPANY,LIMITED [JP/JP]; 3-5-1,Nihonbashi Honcho,Chuo-ku, Tokyo 1038426 (JP) Claims highly...
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EU: New GMP Implementing Act published
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: The EU Commission has published a new public consultation on an Implementing Act on GMP principles and guidelines for medicinal products for...
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IPI-926, Saridegib
C29H48N2O3S Exact Mass: 504.33856 Saridegib also known as IPI-926 is an experimental drug candidate undergoing clinical trials for the treatment of various types of cancer, including hard to treat...
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Ombitasvir
Ombitasvir; ABT-267; ABT 267; UNII-2302768XJ8; 1258226-87-7; C50H67N7O8 Molecular Weight: 894.10908 g/mol Anti-Viral Compounds [US2010317568] Dimethyl...
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GSK 1059615
GSK1059615; 958852-01-2; GSK-1059615; UNII-07YMO87363; GSK 615 (5Z)-5-[(4-pyridin-4-ylquinolin-6-yl)methylidene]-1,3-thiazolidine-2,4-dione...
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GSK1904529A, GSK 4529
GSK1904529A, GSK 4529 GSK1904529A is a selective inhibitor of IGF1R with IC50 of 27 nM. 851.96 Formula C44H47F2N9O5S CAS Number 1089283-49-7...
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Actual Interpretation of the GMP Requirements for Active Pharmaceutical...
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Actual Interpretation of the GMP Requirements for Active Pharmaceutical Ingredients: APIC revises the “How to do” Document on ICH Q7 The...
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ARTEMISININ
Artemisinin is a sesquiterpene lactone with an endoperoxide function. It was first isolated from the Chinese traditional herb—Artemisia annua L. and its structure was first confirmed by Chinese...
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As of September 2015, updated Requirements apply to the Application of a CEP!
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: As of September 2015, updated Requirements apply to the Application of a CEP! The EDQM recently revised its certification policy. Read more...
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Improved one-pot synthesis of N,...
Tolterodine is chemically known as (R)-N,N-disiopropyl-3-(2-hydroxy-5-methyl phenyl)-3-phenyl propyl amine. Tolterodine acts as a muscarinic receptor antagonist. It is useful in the treatment of...
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GSK2334470
GSK2334470 GSK2334470; 1227911-45-6; GSK-2334470; GSK 2334470; (3S,6R)-1-[6-(3-Amino-1H-indazol-6-yl)-2-(methylamino)-4-pyrimidinyl]-N-cyclohexyl-6-methyl-3-piperidinecarboxamide...
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Wockhardt, WO 2015136473, sodium (2S,...
WO-2015136473 https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2015136473&redirectedID=true WOCKHARDT LIMITED [IN/IN]; D-4, MIDC Area, Chikalthana, Aurangabad 431006 (IN) Our New Drug...
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Wockhardt, WO 2007023507,...
Cas 928156-95-0, Acetamide, N-[[(5S)-3-[3,5-difluoro-4-[4-(2H-tetrazol-2-yl)-1-piperidinyl]phenyl]-2-oxo-5-oxazolidinyl]methyl]- C18H21F2N7O3 Molecular Weight: 421.401246 g/mol...
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