Cadila Healthcare Moraiya plant gets USFDA warning letter for significant violations of CGMP Medical Dialogues Bureau16 Nov 2019 11:11 AM ISTCadila Healthcare failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilise equipment and utensils at...
Laurus Labs gets 2 USFDA observations for Visakhapatnam facility Farhat Nasim10 Nov 2019 10:00 AM ISTNew Delhi: Drug firm, Laurus Labs Ltd. recently said in a filing that the US health regulator has issued two observations after the inspection of its...
Biocon gets EIR from USFDA for Bengaluru biologics unit Medical Dialogues Bureau6 Nov 2019 9:19 AM ISTNew Delhi: Biopharmaceutical firm Biocon on Tuesday said it has received an establishment inspection report (EIR) from the US health regulator for its...
Lupin gets USFDA nod for generic version of Levoxyl tablets to treat hypothyroidism Medical Dialogues Bureau2 Nov 2019 10:00 AM ISTThe product is a generic version of King Pharmaceuticals Research and Development LLC's Levoxyl tablets in same strengths, Lupin said.New Delhi: Drug...
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...
Aurobindo Pharma Unit-7 documents inaccurate, misleading: USFDA Medical Dialogues Bureau11 Oct 2019 10:00 AM IST"The responsibilities and procedures applicable to the quality control unit are not fully followed. Several lists of documents requested were either...
Torrent Pharma shares slump 3pc on USFDA warning letter for Gujarat facility Medical Dialogues Bureau11 Oct 2019 9:15 AM ISTTorrent Pharma does not believe that the warning letter will have an impact on the disruption of supplies or the existing revenues from operations of...
SPARC neonatal seizures drug Phenobarbital gets Orphan Drug Designation from USFDA Farhat Nasim5 Oct 2019 12:00 PM ISTOrphan Drug Designation will grant seven years of US market exclusivity upon approval of Phenobarbital for the treatment of patients with neonatal...
Biocon gets USFDA Form 483 with 8 observations for 2 new facilities in Bengaluru Medical Dialogues Bureau23 Sept 2019 10:15 AM IST"At the conclusion of the inspection, we received a Form 483 with four observations for the new Drug Substance facility, three observations for the...
Laurus Labs gets USFDA Establishment Inspection Report for Visakhapatnam units Medical Dialogues Bureau6 Sept 2019 1:03 PM ISTThe establishment inspection report (EIR) from US Food and Drug Administration (USFDA) is for company's active pharmaceutical ingredients units 1 and...
Granules India gets 2 USFDA observations for Chantilly facility Medical Dialogues Bureau23 Aug 2019 11:46 AM IST"The United States Food and Drug Administration (USFDA) has completed inspection of the facility of Granules Pharmaceuticals Inc, a wholly-owned...
Dr Reddys gets 8 USFDA observations for Duvvada facility in Andhra Pradesh Medical Dialogues Bureau21 Aug 2019 10:00 AM ISTThe audit of Dr Reddy's formulations manufacturing plant (Vizag SEZ Plant 1) at Duvvada, Visakhapatnam by the United States Food and Drug...
