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Nacubactam, A diazabicyclooctane beta-lactamase inhibitor, for treating...

  Nacubactam RG-6080,  FPI-1459,  OP-0595, WK ?, WK-?, WK?  CAS 1452458-86-4,  MF C9 H16 N4 O7 S, MW 324.31 Sulfuric acid,...

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Olopatadine

Olopatadine hydrochloride is an antihistamine (as well as anticholinergic and mast cell stabilizer), sold as a prescription eye dropmanufactured by Alcon in one of three strengths: 0.7% solution or...

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Flow Grignard and Lithiation: Screening Tools and Development of Continuous...

ORGANIC CHEMISTRY SELECT Efficient continuous Grignard and lithiation processes were developed to produce one of the key regulatory starting materials for the production of edivoxetine hydrochoride....

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High Throughput Enzymatic Enantiomeric Excess: Quick-ee

Green Chemistry International . High throughput screening techniques (HTS) are fast and efficient alternatives to evaluate enzymatic activities. Here, this technique is applied to obtain enantiomeric...

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The continuous flow Barbier reaction: an improved environmental alternative...

Green Chemistry International A key pharmaceutical intermediate (1) for production of edivoxetine·HCl was prepared in >99% ee via a continuous Barbier reaction, which improves the greenness of the...

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AZD-1236 Revisited

AZD1236 CAS 459814-89-2, MF C15 H19 Cl N4 O5 S.  MW402.85 2,4-Imidazolidinedione, 5-[[[4-[(5-chloro-2-pyridinyl)oxy]-1-piperidinyl]sulfonyl]methyl]-5-methyl-, (5S)-...

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Osanetant , SR-142,801

Osanetant (SR-142,801) 160492-56-8 CAS : MW 605.257582985 Chemical Formula C35H41Cl2N3O2...

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WHAT ARE SUPERGENERICS

DRUG REGULATORY AFFAIRS INTERNATIONAL View original postFiled under: Uncategorized

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Two new FDA Warning Letters for API Manufacturers in China

DRUG REGULATORY AFFAIRS INTERNATIONAL Two new FDA Warning Letters for API Manufacturers in China In June 2016, two API manufacturers in China received a Warning Letter from the FDA. Both companies had...

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Is AQL Testing required within the 100% Visual Inspection?

DRUG REGULATORY AFFAIRS INTERNATIONAL Is AQL Testing required within the 100% Visual Inspection? One of the most frequently asked questions is whether an additional testing based on samples is...

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ACT-334441, Cenerimod an S1P receptor 1 agonist

ACT-334441 Cenerimod UNII-Y333RS1786; Y333RS1786 S1P receptor 1 agonist CAS 1262414-04-9 Chemical Formula: C25H31N3O5 Exact Mass: 453.22637 Actelion Pharmaceuticals Ltd. Martin Bolli, Cyrille Lescop,...

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ROMIDEPSIN

   Romidepsin; Depsipeptide; FK228; Chromadax; FR901228; Istodax; Molecular Formula: C24H36N4O6S2 Molecular Weight: 540.69584 g/mol CAS 128517-07-7...

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Fortune India presents award to Ajanta pharma

Fortune India has published list of 500 mid-size companies who ranked them on various parameters based on the results of 2013-2014. Ajanta pharma features very prominently in the lists. Ajanta’s...

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D2/5-HT2A receptor dual antagonist, (±)-SIPI 6360

(±)-SIPI 6360 D2/5-HT2A receptor dual antagonist 7-[3-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]propoxy]-3-methyl-3,4-dihydro-1H-quinolin-2-one 2(1H)-Quinolinone,...

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ECA Task Force will publish Draft Data Integrity Guideline at Conference in...

DRUG REGULATORY AFFAIRS INTERNATIONAL Data Integrity has become one of the most frequently observed GMP deviations at FDA and EU Inspections. For that reason the ECA Foundation decided to set up a...

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New aspects of developing a dry powder inhalation formulation applying the...

DRUG REGULATORY AFFAIRS INTERNATIONAL The current work outlines the application of an up-to-date and regulatory-based pharmaceutical quality management method, applied as a new development concept in...

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ミチグリニドカルシウム水和物 , Mitiglinide calcium hydrate, 快如妥/Glufast

Mitiglinide MF C19H25NO3 MW 315.407 Da Mitiglinide (INN, trade name Glufast) is a drug for the treatment of type 2 diabetes.[1] Mitiglinide belongs to the meglitinide class of blood glucose-lowering...

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SNS-032, BMS-387032 A potent and selective Cdk inhibitor

SNS 032, BMS-387032 N-[5-[[[5-(1,1-Dimethylethyl)-2-oxazolyl]methyl]thio]-2-thiazolyl]-4-piperidinecarboxamide Cas 345627-80-7, MP 165-167° C M.Wt:380.53, Formula:C17H24N4O2S2   SNS 032, BMS-387032...

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ALMOREXANT REVISITED

Almorexant; ACT-078573;  (R)-2-((S)-6,7-Dimethoxy-1-(4-(trifluoromethyl)phenethyl)-3,4-dihydroisoquinolin-2(1H)-yl)-N-methyl-2-phenylacetamide; Almorexant (INN, codenamed ACT-078573) is an orexin...

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1, 2-Bis(4-(4-4-nitrophenyl)piperazin-1-yl)ethanone for androgen sensitive...

  1, 2-Bis(4-(4-4-nitrophenyl)piperazin-1-yl)ethanone Molecular Formula: C22H26N6O5 Molecular Weight: 454.47904 g/mol CAS 330633-91-5 CDRI-? For treatment of androgen sensitive prostatic disorders 1,...

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