USFDA cautions Aurobindo Pharma's oral solids formulation facility of regulatory action MD bureau31 Jan 2020 1:29 PM ISTNEW DELHI: Drug firm Aurobindo Pharma on Thursday reported that the US health regulator has cautioned that its oral solids formulation manufacturing...
USFDA issues Form 483 with 5 observations to Biocon Bengaluru facility MD bureau28 Jan 2020 2:24 PM ISTNew Delhi: Biocon Ltd on Monday said the US health regulator conducted a pre-approval inspection and good manufacturing practice (GMP) examination of...
Aurobindo Pharma targets to achieve zero debt in three years sans Novartis deal Medical Dialogues Bureau26 Nov 2019 9:30 AM ISTIn September 2018, the USD three billion drug-maker, Aurobindo Pharma said its US subsidiary entered into an agreement to acquire commercial...
Pfizer Abrilada, biosimilar to Humira gets USFDA nod for multiple inflammatory conditions Farhat Nasim20 Nov 2019 12:44 PM ISTNew Delhi: Pfizer Inc. recently announced the United States (U.S.) Food and Drug Administration (USFDA) has approved ABRILADA (adalimumab-afzb), as a...
Zydus Cadila receives warning letter from USFDA for Moraiya-based formulation facility Medical Dialogues Bureau5 Nov 2019 12:57 PM ISTNew Delhi: Drug firm Zydus Cadila on Monday said it has received a warning letter from the US health regulator for its Moraiya-based formulation...
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...
Shilpa Medicare Telangana facility gets EIR from USFDA Medical Dialogues Bureau26 Oct 2019 11:46 AM IST"The USFDA has concluded that the inspection classification of Jadcherla facility was "voluntary action indicated". This facility is in an acceptable...
Cadila Healthcare arm gets USFDA nod for Haloperidol Decanoate injection to treat schizophrenia Medical Dialogues Bureau25 Oct 2019 11:32 AM ISTHaloperidol is used in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette syndrome, Cadila Healthcare...
Roche Tecentriq, Avastin combo to increase overall survival, progression-free survival in HCC Medical Dialogues Bureau22 Oct 2019 9:50 AM ISTRoche, in its recent release, in 2018, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for Tecentriq in...
Sanofi pulls popular heartburn drug Zantac in US, Canada Medical Dialogues Bureau21 Oct 2019 9:30 AM ISTIn September, the Food and Drug Administration said a potentially cancer-causing chemical had been detected at low levels in prescription and...
Mylan moves application with DCGI to launch new TB drug Pretomanid in India Medical Dialogues Bureau16 Oct 2019 4:10 PM IST"We have submitted the new drug application to the office of DCGI. We are in an advanced stage of discussion and are working with the office of...
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...
