IOL Chemicals and Pharma Ibuprofen manufacturing facilities in Barnala clears USFDA inspection Medical Dialogues Bureau30 Oct 2019 8:41 AM GMTMumbai: IOL Chemicals and Pharmaceuticals (IOLCP) recently received a communication from US Food and Drug Administration (USFDA) with respect to an...
Piramal Enterprises plans to raise upto Rs 1000 crore via NCDs Medical Dialogues Bureau28 Oct 2019 4:15 AM GMTThe administrative committee of the board approved the issue of secured NCDs on private placement basis up to Rs 500 crore with an option to retain...
Cadila Healthcare arm gets USFDA nod for Haloperidol Decanoate injection to treat schizophrenia Medical Dialogues Bureau25 Oct 2019 6:02 AM GMTHaloperidol is used in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette syndrome, Cadila Healthcare...
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...
Aurobindo Pharma Unit-7 documents inaccurate, misleading: USFDA Medical Dialogues Bureau11 Oct 2019 4:30 AM GMT"The responsibilities and procedures applicable to the quality control unit are not fully followed. Several lists of documents requested were either...
Torrent Pharma shares slump 3pc on USFDA warning letter for Gujarat facility Medical Dialogues Bureau11 Oct 2019 3:45 AM GMTTorrent Pharma does not believe that the warning letter will have an impact on the disruption of supplies or the existing revenues from operations of...
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...
Cadila Healthcare to sell right of cholesterol-lowering drug Zypitamag for Rs 49 crore Farhat Nasim1 Oct 2019 8:43 AM GMTThe company has entered into an asset purchase agreement to sell its right, title and interest in Zypitamag, along with applicable registrations and...
Biocon gets USFDA Form 483 with 8 observations for 2 new facilities in Bengaluru Medical Dialogues Bureau23 Sep 2019 4:45 AM GMT"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 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...