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Mehta Api Pvt Ltd, Cinacalcet hydrochloride, New patent, WO 2016027211
Mehta Api Pvt Ltd, Cinacalcet hydrochloride, New patent, WO 2016027211 Mehta Api had cinacalcet hydrochloride under development and holds US DMF and European DMF as listed on the company’s...
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New Drug Approvals Blog has 2 lakh plus viewers in USA alone
New Drug Approvals Blog has 2 lakh plus viewers in USA alone that is 200 thousand viewers A record 1170135 views (11 lakh plus)all over the world in 211 countries that is 1100 thousand plus views on...
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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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ODM-201
ODM 201, BAY 1841788; ODM-201 N-((S)-1-(3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl)propan-2-yl)-5-(1-hydroxyethyl)-1H-pyrazole-3-carboxamide cas 1297538-32-9 Chemical Formula: C19H19ClN6O2 Exact...
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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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An Improved Process for the Preparation of Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate For full details see end of page PAPER The current three-step manufacturing route for the preparation of tenofovir disoproxil fumarate (1) was assessed and optimized...
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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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Trioxacarcin A
Trioxacarcin A, DC-45A CAS No. 81552-36-5 Molecular FormulaC42H52O20 Average mass876.850 Da...
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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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EGF 816 , Nazartinib
EGF 816, Nazartinib EGF-816; EGFRmut-TKI EGF816 Novartis Ag innovator (R,E)-N-(7-chloro-1-(1-(4-(dimethylamino)but-2-enoyl)azepan-3-yl)-1H-benzo[d]imidazol-2-yl)-2-methylisonicotinamide...
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罗西替尼 роцилетиниб روسيليتينيب Rociletinib, CO-1686. Third generation covalent...
Rociletinib (CO-1686) AVL-301,CNX-419 Celgene (Originator) , Clovis Oncology N-(3-{[2-{[4-(4-acetylpiperazin-1-yl)-2-methoxyphenyl]amino}-5- (trifluoromethyl)pyrimidin-4-yl]amino}phenyl)prop-2-enamide...
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PF-06747775 (Pfizer) Third generation covalent EGFR inhibitors
PF-06747775 (Pfizer) PF06747775; PF06747775; PF 06747775; PF6747775; PF 6747775; PF6747775. PFE-X775...
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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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