Lupin gets 5 USFDA observations for Vizag facility Medical Dialogues Bureau20 Jan 2020 11:24 AM IST The inspection for the API facility at Vizag closed with five 483 observations, Lupin said. New Delhi: Drug firm Lupin on Saturday said it has...
Granules India recalls over 2.3 cr ranitidine tablets from US market Farhat Nasim13 Jan 2020 11:59 AM ISTNew Delhi: Drug firm Granules India is recalling over 2.3 crore ranitidine tablets, used to treat ulcers of the stomach and intestines, from the US...
Lupin gets 2 observations from USFDA for Nagpur facility Medical Dialogues Bureau13 Jan 2020 11:58 AM ISTDrug firm Lupin on Saturday said it has received two observations from the US health regulator following the inspection of its Nagpur manufacturing...
Cadila Healthcare gets EIR from USFDA for Baddi facility Medical Dialogues Bureau1 Nov 2019 2:11 PM ISTNew Delhi: Drug firm Cadila Healthcare on Thursday said its Baddi facility in Himachal Pradesh has received establishment inspection report (EIR) from...
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...
Zydus Cadila gets USFDA nod for Colesevelam Hydrochloride tablets for lowering cholesterol Medical Dialogues Bureau10 Oct 2019 11:34 AM ISTZydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Colesevelam Hydrochloride tablets,...
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...
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...
Cipla gets 12 USFDA observations for Goa facility Medical Dialogues Bureau30 Sept 2019 3:15 PM IST"The United States Food and Drug Administration (USFDA) conducted a cGMP inspection at our Goa manufacturing facility from September 16-27, 2019,"...
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...
Dr Reddys unveils generic version of Zyban ER tablets in US Medical Dialogues Bureau5 Sept 2019 5:01 PM ISTThe company has launched Bupropion hydrochloride extended-release tablets USP (SR), approved by the United States Food and Drug Administration...
Lupin unveils generic version of Prozac tablets in US Medical Dialogues Bureau24 Aug 2019 9:45 AM ISTFluoxetine tablet is a generic version of Eli Lilly and Company's Prozac tablets in the same strengths, Lupin said.Mumba: Pharma major Lupin Limited...
