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GDUFA: FDA’s new Guidance on Self-Identification of Generic Drug Manufacturers
GDUFA: FDA’s new Guidance on Self-Identification of Generic Drug Manufacturers FDA’s new Guidance requesting generic drug manufacturers who want to export to the USA to self-identify has recently been...
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BMT-145027
BMT-145027 C23H14ClF3N4 Exact Mass: 438.0859 3-(4-chloro-3-(trifluoromethyl)phenyl)-4-cyclopropyl-6-phenyl-1H-pyrazolo[3,4-b]pyridine-5-carbonitrile 3-(4-chloro-3-...
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MCC 950
MCC 950 256373-96-3 (sodium salt); 210826-40-7 (free form). MCC950; CP-456773; CAS 210826-40-7; DSSTox_CID_27301; DSSTox_RID_82252; DSSTox_GSID_47301; CP-456,773; CRID3...
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BMS 906024
BMS 906024 cas 1401066-79-2 MF C26H26F6N4O3 MW 556.500 (2R,3S)-N-[(3S)-1-Methyl-2-oxo-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-3-yl]-2,3-bis(3,3,3-trifluoropropyl)succinamide Butanediamide,...
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BMS-986115
BMS-986115 CAS 1584647-27-7 (2R,3S)-N-((3S)-5-(3-Fluorophenyl)-9-methyl-2-oxo-2,3-dihydro-lH-l,4-benzodiazepin- 3-yl)-2, -bis(3,3,3-trifluoropropyl)succinamide MW: 574.4945, C26-H25-F7-N4-O3, UNII:...
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ENZYMES AS GREEN CATALYSTS FOR PHARMACUETICAL INDUSTRY
Green Chemistry International ENZYMES AS GREEN CATALYSTS FOR PHARMACUETICAL INDUSTRY ‘Green’ Catalysts for ‘greener’ reactions – Dr. Dinesh Nair, Regional Business Manager at Novozymes South Asia Pvt....
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QbD Presentations
Organizational Initiatives Towards Developing Greener Processes for Generic Active Pharmaceutical Ingredients – Dr. Vilas H. Dahanukar, Chief Scientist-Process R&D, Integerated Product Development...
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BMS 986001, Censavudine, Festinavir
BMS 986001 Censavudine, Festinavir Has anti-HIV activity. IN PHASE 2 CAS: 634907-30-5, UNII: 6IE83O6NGA, OBP 601, 4′-Ethynyl D4T, 4′-Ed4T, TDK-4-114 Molecular Formula, C12-H12-N2-O4, Molecular Weight,...
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Register Today for the ACS Symposium in India on Recent Advances in Drug...
Inaugural ACS Industry Symposium, 11-12 November 2016 in Hyderabad, India Recent Advances in Drug Development Register Today for the ACS Symposium in India on Recent Advances in Drug Development To...
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CB-618
CB-618, CB-238618 CAS 1463520-70-8 C8 H10 N4 O6 S, 290.25 Sulfuric acid, mono[(1R,2S,5R)-2-(1,3,4-oxadiazol-2-yl)-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl] ester (25, 5R)-sulfuric acid...
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Ranitidine
Ranitidine Ranitidine, sold under the trade name Zantac among others, is a medication that decreases stomach acid production.[1] It is commonly used in treatment of peptic ulcer disease,...
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What are the GMP Responsibilities of the Marketing Authorisation Holders?
DRUG REGULATORY AFFAIRS INTERNATIONAL The European Medicines Agency (EMA) has published a concept paper to summarise the GMP responsibilities of the Marketing Authorisation Holders (MAH)....
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How does a company demonstrate the implementation of PQS in accordance with ICH?
DRUG REGULATORY AFFAIRS INTERNATIONAL ICH Q10 was published in its final version already in 2008. However, today many companies still have problems to understand how to implement ICH Q10...
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WAY-315193
WAY-315193 7-Fluoro-1-[(1S,2R)-1-(3-fluorophenyl)-2-hydroxy-3-(methylamino)propyl]-3,3-dimethylindolin-2-one Hydrochloride Drugs that possess norepinephrine reuptake inhibition, either selectively or...
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Onions contain a powerful cancer fighting compound — ClinicalNews.Org
Onions contain a powerful cancer fighting compound Onions contain a powerful cancer fighting compound We review the study” Anti-cancer effects found in natural compound derived from onions ” This...
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BMS-741672
BMS-741672 N-((1R,2S,5R)-5-(Isopropyl(methyl)amino)-2-((S)-2-oxo-3-(6-(trifluoromethyl)quinazolin-4-ylamino)pyrrolidin-1-yl)cyclohexyl)acetamide BMS-741672...
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Counterfeit of medicines causes 37,000 job losses in EU Pharma Industry
DRUG REGULATORY AFFAIRS INTERNATIONAL Counterfeit medicine is an increasing problem for public health and economy. This is no longer a problem of certain regions such as Asia and Africa. It has now...
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The impact of the FDA Combination Products Guidance on Nasal and Oral...
DRUG REGULATORY AFFAIRS INTERNATIONAL The FDA draft guidance for combination products has a substantial impact on the development of Oral Inhalation and Nasal Drug Products (OINDPs) as it requires...
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FDA presentation at the ECA Conference Particles in Parenterals
DRUG REGULATORY AFFAIRS INTERNATIONAL At the Particles in Parenterals Conference Dr Stephen Langille from the US FDA gave a talk on the FDA’s current thinking with regard to the visual inspection of...
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Critical Impurities in Pharmaceutical Water
DRUG REGULATORY AFFAIRS INTERNATIONAL The quality of the source water used to produce pharmaceutical water plays an important role for both the design of the treatment and the validation of the water...
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