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...
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...
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...
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,...
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...
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...
Natco Pharma gets 6 USFDA observations for API facility near Hyderabad Medical Dialogues Bureau13 Aug 2019 1:16 PM ISTNatco Pharma said it will provide due justifications and corrective action plan within the next 15 working days to address the USFDA observations.NEW...
Shilpa Medicare gets 5 USFDA observations for Raichur facility Medical Dialogues Bureau31 July 2019 9:30 AM IST"We have received Form 483 with five observations, with no repeat observations and any data integrity observations. The observations are mostly...
USFDA issues warning letter to Indoco Remedies for Goa plant Medical Dialogues Bureau16 July 2019 11:39 AM ISTThe facility had received six observations in Form 483s and was classified as Official Action Indicated in March. Indoco Remedies responded to these...
Alembic Pharma clears USFDA inspection at oncology unit in Panelav Farhat Nasim29 Jun 2019 10:02 AM ISTThis was a first scheduled inspection and Alembic Pharma passed the inspection without any Form 483 Observation.New Delhi: Alembic Pharmaceuticals...
Sun Pharma gets 11 USFDA observations for Dadra plant, BSE asks for response: Report Farhat Nasim26 April 2019 2:20 PM ISTNew Delhi: Sun Pharmaceutical (Sun Pharma) Industries Ltd's Dadra plant has reportedly received 11 observations, "serious" in nature from the U.S....
