According to ICH, an impurity in a drug substance is defined as-“any component of the new drug substance that is not the chemical entity defined as the new drug substance”. There is an ever increasing interest in impurities present in APIs recently, not only purity profile but also impurit...
Project Area :Drug Quality Assurance Product Web Link Stock Recap #PipelineProspector Data Compilation #PharmaFlow Contact Teva Api and get a quotation Teva Api is a supplier offers 498 products (APIs, Excipients or Intermediates). Find a price ofAmitriptyline Hydrochloridebulk with DMF, CEP, JDMF...
Rivaroxaban from Dr.Reddy’s: Full basket offerings of API and Finished formulations 2021 Dr. Reddy's Mirabegron API offering in both alpha and amorphous form 2021 Palbociclib – how a novel process development approach provides IP advantages 2020 Dr. Reddy's Elagolix API offering leverages a...
Active Pharmaceutical Ingredients Drug Discovery Pharmaceutical Research Preclinical Research Pharmaceutical Research Intermediates Active Pharmaceutical Ingredients Route Selection Drug Solid-State Research Service Solid Form Screening Service Green Chemistry Platform Production Process Optimization Clinical Sample ...
List of Drug Master Files (DMF) of Ticagrelor Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website
Grosso, Low level drug product API form analysis - Avalide tablet NIR quantitative method development and robustness chal- lenges, J. Pharm. Biomed. Anal. 89 (2014) 268-275.D. Pan, G. Crull, S. Yin, J. Grosso, Low level drug product API form analysis - avalide tablet NIR quantitative...
What packaging and enabling technologies are best to move the drug substance to formulation? How can we organize a consistent quality control and quality assurance mechanism to avoid full retesting at each step of the value chain? How do we avoid liability ...
We have expanded the scope of pharmacy services while enhancing the capability and level of pharmacy services to offer a full CDMO service. Innovative Drug Process Research & Declaration We provide preclinical and clinical stage API process development, optimization, manufacturing and filing services. ...
Full size image Discussion DOX is a powerful, commonly prescribed and a strong anti-cancer drug. However, its clinical application is limited due to its potential side effects such as, cardiotoxicity37, hepatotoxicity38, nephrotoxicity39and testicular toxicities40. DOX intoxication is reported to distu...
2.1 Nomenclature(INN,Systematic,CAS,etc.)2.2 Properties(structure,stereochemistry,etc)2.3 Siteofmanufacture2.4 Routeofsynthesis(impurities,etc)2.5 Specifications(pharmacopoeia?)2.6 Containerclosuresystem2.7 Stabilitytesting–re-testperiodstorage-OpenpartofDrugMasterFile-submit(DMF)CEP(onlylimitedinformationrequired)...