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,...
Shilpa Medicare gets 2 USFDA observations for Telangana facility Medical Dialogues Bureau9 Sept 2019 11:50 AM ISTThe US Food and Drug Administration (USFDA) inspected the company's finished dosage formulation facility located at Pharmaceutical Formulations SEZ,...
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...
Lupin gets EIR from USFDA for Oral Dosage facility in Aurangabad Medical Dialogues Bureau5 Aug 2019 9:45 AM ISTLupin Ltd's Aurangabad facility is involved in the manufacture of Oral Solid Dosage, Oral Liquid and Powder for Oral Suspension products for the US...
Unichem Labs gets 4 USFDA observations for Goa formulation facility Farhat Nasim3 Aug 2019 9:39 AM ISTAt the end of an inspection, the facility received four observations, with no repeat observations and are mostly procedural in nature, Unichem Labs...
Cadila Healthcare Ankleshwar facility successfully completes USFDA inspection Medical Dialogues Bureau1 Aug 2019 9:25 AM IST"The United States Food and Drug Administration (USFDA) inspected the company's active pharmaceutical ingredient manufacturing facility located at...
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...
