Clik here to view.
ICH M8 “Specification for Submission Formats for eCTD”
DRUG REGULATORY AFFAIRS INTERNATIONAL This additional specification describes the way files should be constructed for inclusion in the eCTD. Key Points: It is not necessary to use a product from Adobe...
View ArticleClik here to view.
ICH Q3D Implementation Working Group (IWG)—Training Modules
DRUG REGULATORY AFFAIRS INTERNATIONAL ICH Q3D Implementation Working Group (IWG)—Training Modules ICH Q3D is a complex guideline. The overall requirement in terms of control is clear—there are defined...
View ArticleClik here to view.
PDE4 Inhibitors, Boehringer Ingelheim Pharmaceuticals
R CONF SHOWN BI ? (R)-2-(4-(4-Chlorophenoxy)piperidin-1-yl)-4-((tetrahydro-2H-pyran-4-yl)amino)-6,7-dihydrothieno[3,2-d]pyrimidine 5-Oxide C22 H27 Cl N4 O3 S, 462.99 CAS 1910076-27-5...
View ArticleClik here to view.
MK 8718
MK 8718 Cas 1582729-24-5 (free base); 1582732-29-3 (HCl). MF: C30H30ClF6N5O4 MW: 673.1891 INNOVATOR Merck Sharp & Dohme Corp., Merck Canada Inc....
View ArticleClik here to view.
MK-7145
MK-7145, cas 1255204-84-2 1(3H)-Isobenzofuranone, 5,5′-(1,4-piperazinediylbis((1R)-1-hydroxy-2,1-ethanediyl))bis(4-methyl- MF C26 H30 N2 O6, Molecular Weight 466.53 1(3H)-Isobenzofuranone,...
View ArticleClik here to view.
FDA´s new policy regarding grouping of supplements for CMC changes
DRUG REGULATORY AFFAIRS INTERNATIONAL The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) released a new document outlining how supplements can be grouped together and...
View ArticleClik here to view.
EMA publishes Q A on data required for sterilized primary packaging materials...
DRUG REGULATORY AFFAIRS INTERNATIONAL The European Medicines Agency, EMA, recently published questions and answers on what data is required for sterilisation processes of primary packaging materials...
View ArticleClik here to view.
ICH M7
DRUG REGULATORY AFFAIRS INTERNATIONAL ICH M7 Although relatively quiet in terms of any specific regulatory activities, the last 6 months have seen a plethora of publications that are associated with...
View ArticleClik here to view.
PDE4 inhibitor , Sumitomo Dainippon Pharma Company
2-[2-Methyl-1-(tetrahydro-2H-pyran-4-yl)-1H-benzimidazol-5-yl]-1,3-benzoxazole Hemifumarate Sumitomo Dainippon Pharma Company, CAS FREE FORM 1256966-65-0 Benzoxazole,...
View ArticleClik here to view.
Quisapride Hydrochloride
Quisapride Hydrochloride (R) – quinuclidine-3-5 – ((S) -2 – (( 4 – amino-5-chloro-2-ethoxy benzoylamino) methyl) morpholino) hexanoate IND Filed china A 5-HT4 agonist potentially for the treatment of...
View ArticleClik here to view.
DSM 265 a promising Antimalarial
DSM265 DSM-265; PfSPZ 2-(1,1-difluoroethyl)-5-methyl-N-(4-(pentafluoro-l6-sulfanyl)phenyl)-[1,2,4]triazolo[1,5-a]pyrimidin-7-amine 2-(l,l-difluoroethyl)-5-methyl-N-[4-(pentafluoro- 6– sulfanyl)phenyl]...
View ArticleClik here to view.
Higenamine Hydrochloride
Higenamine Hydrochloride 6,7-Isoquinolinediol, 1,2,3,4-tetrahydro-1-[(4-hydroxyphenyl)methyl]-, hydrochloride (9CI) 6,7-Isoquinolinediol, 1,2,3,4-tetrahydro-1-[(4-hydroxyphenyl)methyl]-,...
View ArticleClik here to view.
FDA approved a switchover from batch to the new technology for production of...
Above is an Illustration example, FDA urges companies to get on board with continuous manufacturing The FDA gave Johnson & Johnson’s ($JNJ) Janssen drug unit the thumbs up last week for the...
View ArticleClik here to view.
Antimycobacterial Agents
Styryl Hydrazine Thiazole Hybrids Will be updated………kindly email amcrasto@gmail.com DATA ABOUT Dehydrozingerone Dehydrozingerone; Feruloylmethane; 1080-12-2;...
View ArticleClik here to view.
CFI-402257
CFI-402257 N-cyclopropyl-4-(7-((((1s,3s)-3-hydroxy-3-methylcyclobutyl)methyl)amino)-5-(pyridin-2-yloxy)pyrazolo[1,5-a]pyridin-3-yl)-2-methylbenzamide N-cyclopropyl-4-(7-( (((Is,...
View ArticleClik here to view.
EU GMP Annex 1 Revision 2016 – what does the pharmaceutical industry expect?
DRUG REGULATORY AFFAIRS INTERNATIONAL Dr Friedrich Haefele, Vice President Fill & Finish Biopharma at Boehringer Ingelheim Dr Friedrich Haefele, Vice President Fill & Finish Biopharma at...
View ArticleClik here to view.
WHO issues revised Guideline on HVAC Systems
DRUG REGULATORY AFFAIRS INTERNATIONAL The World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems for the manufacture of...
View ArticleClik here to view.
Flow synthesis of Fluoxetine
Scheme 1: Flow synthesis of fluoxetine (46). One of the early published examples of industry-based research on multi-step flow synthesis of a pharmaceutical was reported in 2011 by scientists from Eli...
View ArticleClik here to view.
SETIPIPRANT
Setipiprant, KYTH-105 CAS 866460-33-5 2-(2-(1-naphthoyl)-8-fluoro-1,2,3,4-tetrahydropyrido[4,3-b]indol-5-yl)acetic acid...
View ArticleClik here to view.
FDA approves new diagnostic imaging agent FLUCICLOVINE F-18 to detect...
FLUCICLOVINE F-18 Cyclobutanecarboxylic acid, 1-amino-3-(fluoro-18F)-, trans- [ Molecular FormulaC5H818FNO2 Average mass132.124 Da Axumin (fluciclovine F 18) fluciclovinum (18F) GE-148 NMK36...
View Article