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Channel: DR ANTHONY MELVIN CRASTO Ph.D – New Drug Approvals
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FDA publishes Final Guideline on GMP for Combination Products

DRUG REGULATORY AFFAIRS INTERNATIONAL In the beginning of 2015 the FDA has published a draft guideline about GMP for Combination Products. Now the final version has been published. What are the...

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Thailand Drug regulatory Update, Take a peep

DRUG REGULATORY AFFAIRS INTERNATIONAL http://www.fda.moph.go.th/eng/index.stm [PDF]Regulatory Requirement for the Approval of generic Drug in Thailand …...

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EMA publishes Q&A on Health Based Exposure Limits – Does the 1/1000 dose...

DRUG REGULATORY AFFAIRS INTERNATIONAL In 2014 the European Medicines Agency (EMA) issued the Guideline on setting health based exposure limits for use in risk identification in the manufacture of...

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Brigatinib, Бригатиниб, بريغاتينيب , 布格替尼 ,

Brigatinib, AP26113 Molecular Formula: C29H39ClN7O2P Molecular Weight: 584.102 g/mol CAS 1197953-54-0 2,4-Pyrimidinediamine,...

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FOTAGLIPTIN

FOTAGLIPTIN CAS 1312954-58-7 342.37, C17 H19 F N6 O Benzonitrile, 2-[[3-[(3R)-3-amino-1-piperidinyl]-6-methyl-5-oxo-1,2,4-triazin-4(5H)-yl]methyl]-4-fluoro-...

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Nonsteroidal antiandrogens,...

  C12 H17 Br N2 O3, 317.18 Butanamide, N-(2-bromo-6-methoxy-4-pyridinyl)-2-hydroxy-2,3-dimethyl-, (2S)- (S)-N-(2-bromo-6-methoxypyridin-4-yl)-2-hydroxy-2,4-dimethylpentanamide...

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Telcagepant Revisited

Telcagepant, MK-0974 Molecular FormulaC26H27F5N6O3 Average mass566.523 Da 1-piperidinecarboxamide,...

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BMS-960

BMS-960 PRECLINICAL (S)-1-((S)-2-Hydroxy-2-(4-(5-(3-phenyl-4-(trifluoromethyl)isoxazol-5-yl)-1,2,4-oxadiazol-3-yl)phenyl)ethyl)piperidine-3-carboxylic Acid 3-Piperidinecarboxylic acid,...

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Plinabulin

Plinabulin Molecular FormulaC19H20N4O2 Average mass336.388 Da (3Z,6Z)-3-Benzylidène-6-{[4-(2-méthyl-2-propanyl)-1H-imidazol-5-yl]méthylène}-2,5-pipérazinedione 2,5-Piperazinedione,...

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Article 0

Pridopidine Molecular Formula C15H23NO2S Average mass 281.414 Da 346688-38-8  CAS FREE FORM 882737-42-0 (hydrochloride) 1440284-30-9 HBr 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidin 4- (3...

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Hoshinolactam, A new antitrypanosomal lactam

Tropical diseases caused by parasitic protozoa are a threat to human health, mainly in developing countries. Trypanosomiasis (Chagas disease and sleeping sickness) and leishmaniasis, inter alia, are...

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AMG-3969

AMG-3969 M.Wt: 522.46 Cas : 1361224-53-4 , MF: C21H20F6N4O3S WO 2012027261 PRODUCT PATENT Inventors Kate Ashton, Michael David Bartberger, Yunxin Bo, Marian C. Bryan, Michael Croghan, Christopher...

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MK 0633, SETILEUTON

MK 0633, SETILEUTON (-)-enantiomer 910656-27-8 CAS free form MW 463.3817, C22 H17 F4 N3 O4  FREE FORM Tosylate cas 1137737-87-1 2H-1-Benzopyran-2-one,...

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Darifenacin Hydrobromide, 臭化水素酸ダリフェナシン

Darifenacin 2-[(3S)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenylacetamide Darifenacin; Emselex; Enablex; CAS 133099-04-4; UNII-APG9819VLM; US 2004-12-22 APPROVED EU...

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New Website goflow.at online! from C. Oliver Kappe, University of Graz

New Website goflow.at online! C. Oliver Kappe Professor at University of Graz Institute of Chemistry Univ.-Prof. Mag. Dr.rer.nat. +43 316 380-5352 +43 (0) 316 380 – 9840 Oliver.kappe (at) uni-graz.at...

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FDA approves drug to treat Duchenne muscular dystrophy

FDA approves drug to treat Duchenne muscular dystrophy Feb. 9, 2017 The U.S. Food and Drug Administration today approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years...

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FDA approved Trulance for adults with chronic idiopathic constipation (CIC).

Plecanatide FDA approved Trulance on January 19th 2017, a once-daily prescription medication for adults with chronic idiopathic constipation (CIC).   Plecanatide (brand name Trulance), is a drug...

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Lorlatinib, лорлатиниб , لورلاتينيب , 洛拉替尼 , PF-6463922

Lorlatinib, PF-6463922 For Cancer; Non-small-cell lung cancer Molecular Formula C21H19FN6O2 Average mass 406.413 Da Phase 2 WO 2013132376 Andrew James Jensen, Suman Luthra, Paul Francis RICHARDSON...

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Award for me, 100 Most Impactful Health care Leaders Global listing

  At award function for my award “100 Most Impactful Health care Leaders Global listing”, conferred on me at Taj lands end, Mumbai, India on 14 Feb 2014 by World Health Wellness congress and awards...

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FDA approves new psoriasis drug Siliq (brodalumab)

FDA approves new psoriasis drug The U.S. Food and Drug Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection....

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