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Channel: Uncategorized – New Drug Approvals
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Genistein

Genistein 5,7-Dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one; Baichanin A; Bonistein; 4’,5,7-Trihydroxyisoflavone; GeniVida; Genisteol; NSC 36586; Prunetol; Sophoricol; CAS Number: 446-72-0...

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Temanogrel

Temanogrel APD 791 3-methoxy-N-[3-(2-methylpyrazol-3-yl)-4-(2-morpholinoethoxy)phenyl]benzamide Benzamide,3-methoxy-N-[3-(1-methyl-1H-pyrazol-5-yl)-4-[2-(4-morpholinyl)ethoxy]phenyl]- UNII:F42Z27575A...

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TD 1607

TD-1607 Phase I A glycopeptide-cephalosporin heterodimer potentially for the treatment of gram-positive bacterial infection. CAS No. 827040-07-3 C95 H109 Cl3 N18 O31 S2,  Molecular Weight, 2169.47...

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GSK-2838232

GSK-2838232...

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GSK-2816126

GSK-2816126 N-[(1,2-Dihydro-4,6-dimethyl-2-oxo-3-pyridinyl)methyl]-3-methyl-1-[(1S)-1-methylpropyl]-6-[6-(1-piperazinyl)-3-pyridinyl]-1H-indole-4-carboxamide, GSK 126, GSK 2816126, GSK 2816126A...

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GSK-2879552

GSK-2879552 CAS 1401966-69-5 (ABS),  1401966-63-9(REL) C23 H28 N2 O2, 364.48 Benzoic acid, 4-[[4-[[[(1R,2S)-2-phenylcyclopropyl]amino]methyl]-1-piperidinyl]methyl]-...

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GSK-2881078

GSK-2881078 (R)-1-[1-(Methylsulfonyl)propan-2-yl]-4-(trifluoromethyl)-1H-indole-5-carbonitrile (R)-1 -(1-(methylsulfonyl)propan-2-yl)-4-(trifluoromethyl)indoline-5-carbonitrile Phase I A selective...

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Amneal Pharma’s, 4,5-Dihydro-1H-pyrazolo[3,4-d]pyrimidine containing...

Cas 1580464-40-9 MW458.97, C24 H19 Cl N6 S, 1H-Pyrazolo[3,4-d]pyrimidin-6-amine, 4-(4-chlorophenyl)-4,7-dihydro-3-methyl-1-(10H-phenothiazin-2-yl)-...

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Indian API Manufacturers remain in the Focus of European GMP Inspectors

DRUG REGULATORY AFFAIRS INTERNATIONAL Some time ago three Non-Compliance Reports have been published in quick succession in the EudraGMDP database. Those reports deal with inspections performed at...

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Revision of the general Chapter on Pharmaceutical Water in the US Pharmacopoeia

DRUG REGULATORY AFFAIRS INTERNATIONAL The 2nd supplement of USP39 NF34 comprises the revised version of the chapter on pharmaceutical water of the US Pharmacopoeia <1231> Water for...

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Final WHO Guidance Document on Good Data and Record Management Practices

DRUG REGULATORY AFFAIRS INTERNATIONAL The WHO has just released the  the final version of the important guideline “Good Data and Record Management Practices“....

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Novartis, Torrent drug for diabetes, NVP-LBX192, LBX-192

  (R)-3-Cyclopentyl-N-(5-methoxy-thiazolo[5,4-b]pyridin-2-yl)-2-[4-(4-methyl-piperazine-1-sulfonyl)-phenyl]-propionamide...

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FDA publishes Technical Guide on Quality Metrics

DRUG REGULATORY AFFAIRS INTERNATIONAL The FDA has published a supplementing Guide on Quality Metrics. This is a very unusual step as the contents of the guide are planned to be integrated into the...

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Annex 16: How a QP should handle unexpected Deviations

DRUG REGULATORY AFFAIRS INTERNATIONAL In a recent blog of the MHRA, the inspectorate looks at one aspect of the new Annex 16 – the handling of unexpected deviations. see...

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Ripasudil hydrochloride hydrate 塩酸塩水和物 , リパスジル

Ripasudil hydrochloride hydrate 4-fluoro-5-[[(2S)-2-methyl-1,4-diazepan-1-yl]sulfonyl]isoquinoline;dihydrate;hydrochloride 4-Fluoro-5-[2(S)-methylperhydro-1,4-diazepin-1-ylsulfonyl]isoquinoline...

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BRISTOL-MYERS SQUIBB’S TRICYCLOHEXADECAHEXAENE DERIVATIVES FOR USE IN THE...

. TRICYCLOHEXADECAHEXAENE DERIVATIVES FOR USE IN THE TREATMENT OF HEPATITIS C VIRUS CAS 1663477-91-5 C54 H62 F4 N6 O2, 903.10 Cyclohexanecarboxamide,...

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MK 8876

MK 8876 CAS 1426960-33-9 2-(4-Fluorophenyl)-5-(11-fluoro-6H-pyrido[2′,3′:5,6][1,3]oxazino[3,4-a]indol-2-yl)-N-methyl-6-(N-methylmethanesulfonamido)-1-benzofuran-3-carboxamide...

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Eldecalcitol, an active vitamin D3 analog used to treat osteoporosis

Eldecalcitol...

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New bicalutamide/enzalutamide derivatives as antiproliferative agents for the...

3,3,3-trifluoro-2-hydroxy-N-(4-nitro-3-(trifluoromethyl)phenyl)-2-(((2-(trifluoromethyl)phenyl)thio)methyl)propanamide Cas 1929605-82-2 MF C18 H11 F9 N2 O4 S,  MW 522.34 New bicalutamide and...

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EMA reviews Medicines manufactured at U.S. Company

DRUG REGULATORY AFFAIRS INTERNATIONAL Following the issuance of two Non-Compliance Reports for two sites of the US based company, EMA has started a review of medicines manufactured by Pharmaceutics...

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