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...
Alkem Labs closes USFDA inspection of Baddi, Daman facility with 2 observations Medical Dialogues Bureau2 Nov 2019 9:45 AM ISTNew Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received 2 observations from the US health regulator for...
Dr Reddys Srikakulam plant gets 4 USFDA observations Farhat Nasim29 Oct 2019 10:00 AM ISTThe audit of Dr Reddy's API Srikakulam Plant (SEZ) by the United States Food and Drug Administration (USFDA) was completed on Friday, the...
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...
Aurobindo Pharma Unit-7 gets 7 USFDA observations Medical Dialogues Bureau8 Oct 2019 2:54 PM ISTThe United States Food and Drug Administration (USFDA) conducted a Current Good Manufacturing Practices (CGMP) inspection at the company's unit-7...
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...
Dr Reddys gets EIR from USFDA for manufacturing plants at Duvvada Medical Dialogues Bureau13 Sept 2019 11:59 AM ISTThe company has received EIR from the United States Food and Drug Administration (USFDA) for the inspection conducted at the formulations...
Alkem Labs gets EIR from USFDA for St.Louis facility Medical Dialogues Bureau12 Sept 2019 9:30 AM IST"In furtherance to the intimation captioned "US FDA Inspection at Alkem's manufacturing facility located at St. Louis, USA" dated 23rd August, 2019,...
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...
Alkem Labs gets 2 USFDA observations for Daman facility Medical Dialogues Bureau31 Aug 2019 12:32 PM ISTNew Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received two observations from the US health regulator for...
Alkem Labs gets 4 USFDA observations for St Louis facility Medical Dialogues Bureau26 Aug 2019 12:39 PM ISTNew Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received four observations from the US health regulator...
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...
