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FDA approved a switchover from batch to the new technology for production of...
Above is an Illustration example, FDA urges companies to get on board with continuous manufacturing The FDA gave Johnson & Johnson’s ($JNJ) Janssen drug unit the thumbs up last week for the...
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Antimycobacterial Agents
Styryl Hydrazine Thiazole Hybrids Will be updated………kindly email amcrasto@gmail.com DATA ABOUT Dehydrozingerone Dehydrozingerone; Feruloylmethane; 1080-12-2;...
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CFI-402257
CFI-402257 N-cyclopropyl-4-(7-((((1s,3s)-3-hydroxy-3-methylcyclobutyl)methyl)amino)-5-(pyridin-2-yloxy)pyrazolo[1,5-a]pyridin-3-yl)-2-methylbenzamide N-cyclopropyl-4-(7-( (((Is,...
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EU GMP Annex 1 Revision 2016 – what does the pharmaceutical industry expect?
DRUG REGULATORY AFFAIRS INTERNATIONAL Dr Friedrich Haefele, Vice President Fill & Finish Biopharma at Boehringer Ingelheim Dr Friedrich Haefele, Vice President Fill & Finish Biopharma at...
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WHO issues revised Guideline on HVAC Systems
DRUG REGULATORY AFFAIRS INTERNATIONAL The World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems for the manufacture of...
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Flow synthesis of Fluoxetine
Scheme 1: Flow synthesis of fluoxetine (46). One of the early published examples of industry-based research on multi-step flow synthesis of a pharmaceutical was reported in 2011 by scientists from Eli...
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SETIPIPRANT
Setipiprant, KYTH-105 CAS 866460-33-5 2-(2-(1-naphthoyl)-8-fluoro-1,2,3,4-tetrahydropyrido[4,3-b]indol-5-yl)acetic acid...
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FDA approves new diagnostic imaging agent FLUCICLOVINE F-18 to detect...
FLUCICLOVINE F-18 Cyclobutanecarboxylic acid, 1-amino-3-(fluoro-18F)-, trans- [ Molecular FormulaC5H818FNO2 Average mass132.124 Da Axumin (fluciclovine F 18) fluciclovinum (18F) GE-148 NMK36...
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[18F]AMG 580
[18F]AMG 580 CAS 1879904-74-1 MF C26 H24 F N5 O3 NOTE………CAS OF AMG 580 IS 1227067-71-1, WITHOUT 18F AMG 580...
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Difelikefalin
Difelikefalin, CR-845; MR-13A-9; MR-13A9 4-amino-1- (D-phenylalanyl-D-phenylalanyl-D-leucyl-D-lysyl) piperidine-4-carboxylic acid Phase III C36H53N7O6, 679.40573 Originator Ferring Pharmaceuticals...
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Rovatirelin Hydrate
Rovatirelin Hydrate, S-0373, Rovatirelin, RN: 204386-76-5 UNII: 9DL0X410PY...
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[F-18](2S,4S)-4-(3-Fluoropropyl)glutamine
[F-18](2S,4S)-4-(3-Fluoropropyl)glutamine CAS 1196963-79-7 MF C8 H15 F N2 O3 Heptanoic acid, 2-amino-4-(aminocarbonyl)-7-(fluoro-18F)-, (2S,4S)- [18F](2S,4S)-4-FPGln...
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CCT 245737
CCT 245737 CAS:1489389-18-5 M.Wt: 379.34 Formula: C16H16F3N7O 2-Pyrazinecarbonitrile, 5-[[4-[[(2R)-2-morpholinylmethyl]amino]-5-(trifluoromethyl)-2-pyridinyl]amino]-...
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GSK 6853
GSK 6853 CAS 1910124-24-1 C22 H27 N5 O3, 409.48 Benzamide, N-[2,3-dihydro-1,3-dimethyl-6-[(2R)-2-methyl-1-piperazinyl]-2-oxo-1H-benzimidazol-5-yl]-2-methoxy- (R)-N-(1 ,3-...
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Дапипразол Dapiprazole
Dapiprazole CAS 72822-12-9 HCL SALT 72822-13-0 5,6,7,8-Tetrahydro-3-(2-(4-(O-tolyl)-1-piperazinyl)ethyl)-S-triazolo(4,3-a)pyridine Dapiprazole (Rev-Eyes) is an alpha blocker. It is used to reverse...
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Results of a Survey on ICH Q3D “Elemental Impurities”
DRUG REGULATORY AFFAIRS INTERNATIONAL For most companies manufacturing APIs and pharmaceutical products, the implementation of ICH Q3D has a serious impact – as shown in a survey recently carried out...
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EDQM’s new Guideline on Electronic Submissions for CEP Applications
DRUG REGULATORY AFFAIRS INTERNATIONAL EDQM’s new Guideline on Electronic Submissions for CEP Applications As of today (June, 1st 2016), the EDQM doesn’t accept any CEP application in paper format....
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Ladostigil
Ladostigil, TV-3,326 (N-propargyl-(3R) aminoindan-5yl)-ethyl methyl carbamate (3R)-3-(Prop-2-ynylamino)indan-5-yl ethyl(methyl)carbamate; R-CPAI Carbamic acid, ethylmethyl-,...
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Flow Chemistry Symposium & Workshop 16-17 June at IICT, Hyderabad, India
MESSAGE FROM VIJAY KIRPALANI A 2-day FLOW CHEMISTRY Symposium + Workshop has been organized on 16-17 June 2016 at IICT Hyderabad, India by Flow Chemistry Society – India Chapter (in collaboration...
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Obeticholic acid
Obeticholic acid Obeticholic acid; 6-ECDCA; INT-747; 459789-99-2; 6-Ethylchenodeoxycholic acid; 6alpha-Ethyl-chenodeoxycholic acid;...
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