Cadila Healthcare gets EIR from USFDA for Baddi facility Medical Dialogues Bureau1 Nov 2019 8:41 AM GMTNew 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 4:00 AM GMTThis 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 6:04 AM GMTZydus 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 9:24 AM GMTThe 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 6:30 AM GMTOrphan 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 Sep 2019 9:45 AM GMT"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 Sep 2019 6:29 AM GMTThe 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 Sep 2019 11:31 AM GMTThe 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 4:15 AM GMTFluoxetine tablet is a generic version of Eli Lilly and Company's Prozac tablets in the same strengths, Lupin said.Mumba: Pharma major Lupin Limited...
Granules India gets 2 USFDA observations for Chantilly facility Medical Dialogues Bureau23 Aug 2019 6:16 AM GMT"The United States Food and Drug Administration (USFDA) has completed inspection of the facility of Granules Pharmaceuticals Inc, a wholly-owned...
Natco Pharma gets 6 USFDA observations for API facility near Hyderabad Medical Dialogues Bureau13 Aug 2019 7:46 AM GMTNatco Pharma said it will provide due justifications and corrective action plan within the next 15 working days to address the USFDA observations.NEW...
Natco Pharma gets EIR from USFDA for Kothur facility Medical Dialogues Bureau6 Aug 2019 11:05 AM GMTNew Delhi: Drug firm Natco Pharma on Monday said it has received establishment inspection report (EIR) from the US health regulator for its Kothur...
