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Channel: DR ANTHONY MELVIN CRASTO Ph.D – New Drug Approvals
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Sigma-concepts.com a Website for excellent reading with figures & diagrams

READ  http://6sigma-concepts.com/ Dr. Amrendra Kumar Roy QbD Head, Jubilant Generics, NOIDA A Six-sigma and QbD professional akroy1975@gmail.com Twitter 6sigmaconcepts sigma-concepts.com WEBSITE...

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SUGAMMADEX

SUGAMMADEX CAS number 343306-71-8 Weight Average: 2002.12 Monoisotopic: 2000.408874758 Chemical Formula C72H112O48S8 WATCH OUT POST WILL BE UPDATED……… SUGAMMADEX 343306-71-8 cas  free Sugammadex...

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FDA approves Intrarosa for postmenopausal women experiencing pain during sex

FDA approves Intrarosa for postmenopausal women experiencing pain during sex The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain...

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Opportunities for Reducing Sampling and Testing of Starting Materials

DRUG REGULATORY AFFAIRS INTERNATIONAL Chapter 5 of the EC GMP Guide for the area of production was updated last year. This chapter contains concrete information about the conditions when testing and...

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New EDQM’s Public Document informs about the Details required in a New CEP...

DRUG REGULATORY AFFAIRS INTERNATIONAL A Policy Document recently published by the EDQM describes regulations for referencing already existing CEPs in an application for a new CEP. Read more about how...

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Now online – Stimuli article on the proposed USP General Chapter “The...

DRUG REGULATORY AFFAIRS INTERNATIONAL Now online – Stimuli article on the proposed USP General Chapter “The Analytical Procedure Lifecycle <1220>” A Stimuli Article to the Revision Process...

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LUPIN LIMITED, WO 2016181313, NEW PATENT, SOFOSBUVIR

WO2016181313,  A PROCESS FOR THE PREPARATION OF SOFOSBUVIR INTERMEDIATES & ITS POLYMORPH LUPIN LIMITED [IN/IN]; Kalpataru Inspire 3rd Floor, Off Western Express Highway Santacruz (East) Mumbai 400...

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Doxercalciferol, доксэркальциферол , دوكساركالسيفيرول , 度骨化醇

Doxercalciferol Molecular FormulaC28H44O2 Average mass412.648 доксэркальциферол [Russian] دوكساركالسيفيرول [Arabic] 度骨化醇 [Chinese] 1,3-Cyclohexanediol,...

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SUVEN LIFE SCIENCES LTD, WO 2016178064, POLYMORPH OF NINTEDANIB...

NINTEDANIB ETHANESULPHONATE NEW PATENT WO2016178064, CLICK FOR PATENT POLYMORPH OF NINTEDANIB ETHANESULPHONATE, PROCESSES AND INTERMEDIATES THEREOF SUVEN LIFE SCIENCES LIMITED [IN/IN]; 5th floor,...

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Sacubitril, WO 2016180275, New patent, SUZHOU PENGXU PHARMATECH CO., LTD

Sacubitril, WO 2016180275, New patent, SUZHOU PENGXU PHARMATECH CO., LTD AHU-377 INTERMEDIATES AND METHOD FOR PREPARING AHU-377 AND AHU-377 INTERMEDIATES PATENT WO2016180275, new patent, SUZHOU PENGXU...

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IPRAGLIFLOZIN, NEW PATENT, WO2016173551, China State Institute of...

  WO 2016173551 China State Institute of Pharmaceutical Industry; Shanghai Institute of Pharmaceutical Industry...

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WO 2016181414, IVACAFTOR, NEW PATENT, COUNCIL OF SCIENTIFIC & INDUSTRIAL...

CSIR, Dr. D. Srinivasa Reddy WO2016181414, PROCESS FOR THE SYNTHESIS OF IVACAFTOR AND RELATED COMPOUNDS...

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Generics: FDA´s New Guidance on Prior Approval Supplements

DRUG REGULATORY AFFAIRS INTERNATIONAL Generics: The US Food and Drug Administration (FDA) recently published a new Guidance regarding Prior Approval Supplements (PAS). Read more about FDA´s Guidance...

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ZINPLAVA (BEZLOTOXUMAB), Approved FDA

BEZLOTOXUMAB Biologic License Application (BLA): 761046 Company: MERCK SHARP DOHME Drug Name(s): • ZINPLAVA (BEZLOTOXUMAB) http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761046s000lbl.pdf...

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ADRAFINIL

ADRAFINIL...

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Ranolazine Intermediate, An Efficient Synthesis of...

An efficient process for the preparation of 1-(2-methoxyphenoxy)-2,3-epoxypropane, a key intermediate for the synthesis of ranolazine is described. http://pubs.acs.org/doi/suppl/10.1021/op300056k...

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Designing Polymers for Amorphous Solid Dispersions — AAPS Blog

By: Laura I. Mosquera-Giraldo and Lynne S. Taylor Imagine spending billions of dollars in the discovery of a new drug, and then realizing that it is impractical to administer it orally because it...

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Lumefantrine

lumefantrine 2-(dibutylamino)-1-[(9Z)-2,7-dichloro-9-[(4-chlorophenyl)methylidene]-9H-fluoren-4-yl]ethan-1-ol (±)-2,7-Dichloro-9-((Z)-p-chlorobenzylidene)-α-((dibutylamino)methyl)fluorene-4-methanol...

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CEP 33779

CEP-33779, CEP33779 CAS 1257704-57-6 Chemical Formula: C24H26N6O2S Molecular Weight: 462.57 Elemental Analysis: C, 62.32; H, 5.67; N, 18.17; O, 6.92; S, 6.93...

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PIMODIVIR, VX 787

PIMODIVIR VX-787, JNJ-63623872, JNJ-872, VRT-0928787, VX-787, VX 787,  VX787,  JNJ-872, JNJ 872, JNJ872, VRT-0928787, VRT 0928787, VRT0928787, pimodivir...

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