Alkem Labs Bioeguivalcnce Center at Taloja clears USFDA inspection Medical Dialogues Bureau28 Oct 2019 10:00 AM IST"This is to inform that the US FDA had conducted an inspection at Alkem Laboratories Ltd's Bioequivalence Center located at Taloja, Maharashtra from...
CDSCO committee tells Roche to submit Phase III clinical trial data of blood cancer combo drug Farhat Nasim27 Oct 2019 11:30 AM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), recently recommended drugmaker,...
Shilpa Medicare Telangana facility gets EIR from USFDA Medical Dialogues Bureau26 Oct 2019 11:46 AM IST"The USFDA has concluded that the inspection classification of Jadcherla facility was "voluntary action indicated". This facility is in an acceptable...
Dr Reddys recalls Ranitidine products in US over cancer-causing impurity Medical Dialogues Bureau24 Oct 2019 9:30 AM ISTThis recall follows the USFDA's caution note alerting patients and healthcare professionals that NDMA was found in certain samples of ranitidine, Dr...
Cipla acquires novel anti-infective Elores to further antimicrobial stewardship in critical care in India Medical Dialogues Bureau18 Oct 2019 1:50 PM ISTMumbai: Cipla Limited announces the acquisition of a novel and patented anti-infective product, Elores, from Venus Remedies Limited ("VRL") for the...
Illegal renting of licences to Chemists: 241 Gujarat Pharmacists lose Registration Medical Dialogues Bureau17 Oct 2019 12:19 PM IST"This is the first time in India when such large number of pharmacists have been penalised. We have also issued warnings to around 3,000 pharmacists...
Mylan moves application with DCGI to launch new TB drug Pretomanid in India Medical Dialogues Bureau16 Oct 2019 4:10 PM IST"We have submitted the new drug application to the office of DCGI. We are in an advanced stage of discussion and are working with the office of...
Sanofi opens digital biologics manufacturing facility in US Farhat Nasim16 Oct 2019 9:45 AM ISTThe facility in Framingham accelerates the recent transformation of Sanofi's Industrial Affairs organization to focus on biologics-based therapies, in...
Allergan shareholders okays USD 63 billion AbbVie acquisition Medical Dialogues Bureau15 Oct 2019 9:30 AM ISTUnder the terms of the agreement announced on June 25, 2019, AbbVie will acquire Allergan in a cash and stock transaction for a transaction equity...
Morepen Labs adds blockbuster Rivaroxaban, Vildagliptin, UDCA to API portfolio Farhat Nasim14 Oct 2019 1:36 PM ISTWhile two products Rivaroxaban and Vildagliptin will augment Morepen Lab's presence in the cardiac and diabetic segments respectively, the third...
FIRST: Sun Pharma unveils dry-eye treatment drug CEQUA in US Farhat Nasim14 Oct 2019 1:13 PM ISTNew Delhi: Through a release, drug major, Sun Pharmaceutical Industries Ltd. (Sun Pharma) today announced that one of its wholly-owned subsidiaries...
Cadila Healthcare largest API manufacturing site clears USFDA inspection Medical Dialogues Bureau12 Oct 2019 11:41 AM ISTThe US Food and Drug Administration (USFDA) inspected the company's active pharmaceutical ingredients (API) manufacturing facility at Dabhasa from...
