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The new Elemental Impurities Database for Excipients – ECA offers a meeting...
A step-wise integrated risk-based approach to determine a control strategy for according to ICH Q3D has to consider data from all kinds of potential sources for elemental impurities in particular from...
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What are the current Rules for Supplier Qualification?
Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements for qualifying suppliers?...
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FDA Guideline on Dissolution Testing
DRUG REGULATORY AFFAIRS INTERNATIONAL The FDA has presented the draft of a revised guideline on dissolution testing for immediate release. Under certain conditions, the tests can now be standardised....
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ITI 214
ITI 214 IC200214; ITI-214 (6aR,9aS)-2-(4-(6-fluoropyridin-2-yl)benzyl)-5-methyl-3-(phenylamino)-5,6a,7,8,9,9a-hexahydrocyclopenta[4,5]imidazo[1,2-a]pyrazolo[4,3-e]pyrimidin-4-(2H)-one phosphate...
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GALETERONE
Galeterone SYNTHESIS COMING……….. A SARM potentially for the treatment of prostate cancer. Research Code, TOK-001; VN; 124; 124-1; 1241 TOK-001; Galeterone; 851983-85-2; VN/124; UNII-WA33E149SW;...
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Apalutamide, ARN 509
Apalutamide,, ARN 509 synthesis coming…………. ARN-509; cas 956104-40-8; ARN 509; UNII-4T36H88UA7; ARN-509; JNJ-56021927; JNJ-927\ Phase III Prostate cancer...
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Liarozole
Liarozole CAS Registry Number: 115575-11-6 CAS Name: 5-[(3-Chlorophenyl)-1H-imidazol-1-ylmethyl]-1H-benzimidazole Additional Names: (±)-5-(m-chloro-a-imidazol-1-ylbenzyl)benzimidazole Molecular...
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Zydus Chairman and Managing Director,Mr. Pankaj R. Patel won the prestigious...
Zydus Group Zydus Chairman and Managing Director,Mr. Pankaj R. Patel won the prestigious ‘Gujarat Business Leader of the Year’ award at the CNBC Bajar, Gujarat Ratna Awards 2015-16 from Hon’ble Chief...
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New FDA Guidance on Completeness Assessements for Type II API Drug Master Files
DRUG REGULATORY AFFAIRS INTERNATIONAL Since 1st October 2012, special regulations have been applying to the US Type II Drug Master Files. This year in February, the FDA published a new Guidance for...
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LAMIVUDINE
Lamivudine CAS Registry Number: 134678-17-4 CAS Name: (2R-cis)-4-Amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1H)-pyrimidinone Additional Names: (-)-2¢-deoxy-3¢-thiacytidine;...
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HELP, Need one time help to pay 10 year concessional subscription to this,...
Just One viewer please come forward Dear Kind Viewer’s WordPress is kind to me and negotiated a one time 10 year concessional subscription of 260 US dollars…….https://newdrugapprovals.org/ I need...
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BRIVARACETAM
BRIVARACETAM, UCB-34714 (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl]butanamide (2S)-2-[(4R)-2-Oxo-4-propyl-1-pyrrolidinyl]butanamide 1-Pyrrolidineacetamide, α-ethyl-2-oxo-4-propyl-, (αS,4R)- CAS...
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Tianagliflozin IND filed by Tianjin Institute of Pharmaceutical research
Tianagliflozin, taigeliejing, 6-deoxydapagliflozin Molecular Formula: C21H25ClO5 Molecular Weight: 392.8732 g/mol IND Filing…Tianjin Institute of Pharmaceutical research Tianjin Institute Of...
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New Drug Approvals Just One viewer please come forward Dear Kind Viewer’s WordPress is kind to me and negotiated a one time 10 year concessional subscription of 260 US...
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IACS -9571
IACS-9571 TRIM24/BRPF1 bromodomain inhibitor IACS-9571; IACS 9571; IACS9571. Molecular Formula: C32H42N4O8S Molecular Weight: 642.76288 g/mol...
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QP Education and Qualification – What is needed?
DRUG REGULATORY AFFAIRS INTERNATIONAL We are frequently asked about the educational requirements in order to become a Qualified Person in Europe. Comprehensive educational modules are offered,...
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EDQM adopts revised monograph for WFI allowing non-destillation techniques
DRUG REGULATORY AFFAIRS INTERNATIONAL In a press release the EDQM has announced that the new monograph draft on Water for Injection (169) had been adopted. Read on to learn more about the production...
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RP 6503, Novartis to develop and commercialize Rhizen’s inhaled dual...
RP 6503 phase 1 RP 6503 Molecular Formula: C30H24F2N6O5S Molecular Weight: 618.610566 g/mol Mass: 619.1 (M++l). MP: 175-178° C Specific optical rotation (C=l in chloroform, at 25°C) : [a]D = +...
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RP 6530, Tenalisib Rhizen Pharmaceuticals S.A.
New Drug Approvals (S)-2-(l-(9H-purin-6-ylamino)propyl)-3-(3-fluorophenyl)-4H-chromen-4-one (Compound A1 is RP 6530). RP 6530 RP 6530, RP6530, RP-6530 Tenalisib RP6530-1401, NCI-2015-01804, 124584,...
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Novartis Molecule for functionally liver selective glucokinase activators for...
2 (R)-3-Cyclopentyl-N-(5-methoxy-thiazolo[5,4-b]pyridin-2-yl)-2-[4-(4-methyl-piperazine-1-sulfonyl)-phenyl]-propionamide...
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