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Channel: DR ANTHONY MELVIN CRASTO Ph.D – New Drug Approvals
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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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ULIXERTINIB, уликсертиниб , أوليكسيرتينيب , 优立替尼 ,

OR ULIXERTINIB 4-(5-chloro-2-isopropylaminopyridin-4-yl)-1H-pyrrole-2-carboxylic acid[1-(3-chlorophenyl)-2-hydroxyethyl]amide Molecular Formula: C21H22Cl2N4O2 Molecular Weight: 433.33098 g/mol...

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CDMO Ash Stevens to Be Acquired by Piramal Enterprises

Piramal Enterprises Limited announced that its wholly owned subsidiary in the U.S. has entered into an agreement to acquire 100 percent stake in Ash Stevens Inc., a U.S.-based contract development and...

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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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NEW BLOG: DRUG APPROVALS INTERNATIONAL

LINK http://drugapprovalsint.com/   http://drugapprovalsint.com/   http://drugapprovalsint.com/   http://drugapprovalsint.com/   /////////////Filed under: Anthony crasto, BLOGS Tagged: Anthony crasto,...

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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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RPL 554

RPL-554 Molecular FormulaC26H31N5O4 Average mass477.555 RPL 554 Urea, N-[2-[(2E)-6,7-dihydro-9,10-dimethoxy-4-oxo-2-[(2,4,6-trimethylphenyl)imino]-2H-pyrimido[6,1-a]isoquinolin-3(4H)-yl]ethyl]-...

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Opicapone

Opicapone 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide BIA-9-1067; ONO-2370; BIA-91067 CAS No.923287-50-7 MF C15H10Cl2N4O6 MW: 411.9977 TRADE NAME...

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Naloxegol

Naloxegol Movantik; NKTR-118; NKTR118; UNII-44T7335BKE; NKTR 118 854601-70-0  cas 1354744-91-4 (Naloxegol Oxalate)...

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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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Pitolisant

Pitolisant 1-(3-(3-(4-Chlorophenyl)propoxy)propyl)piperidine MF  C17H26ClNO MW  295.1703 (Wakix®)Approved EU 31/3/2016, Narcolepsy A histamine H3 receptor antagonist/inverse agonist used to treat...

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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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Olanexidine, オラネキシジングルコン酸塩

Olanexidine Gluconate OPB-2045G, Gluconate olanexidin,  Olanedine,  OPB-2045,  OPB 2045G,  (Olanedine®)Approved in Japan PMDA 2015-07-03, Olanedine® by Otsuka A disinfectant uesd to prevent of...

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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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