Latest News on Usfda
Showing of 0 - 10 from 86 results
Usfda - Total results - 86
Dec 10, 2018
Lupin gets Establishment Inspection Report from USFDA for Pithampur facility unit; stock falls 1.88%Drug firm Lupin on Monday said it has received an Establishment Inspection Report (EIR) from the US health regulator for a unit of its Pithampur facility in Madhya Pradesh.
Nov 27, 2018
Lupin gets observation in establishment inspection report from USFDA for Tarapur facilityShares of Lupin were trading at Rs 854.00 per scrip on the BSE, up 1.09 percent from its previous close.
Nov 21, 2018
Decks cleared for resuming launch of Dr Reddy’s generic Suboxone after US court rejects rival firm’s patent breach caseThe US Court of Appeals for the Federal Circuit concluded that Indivior had not shown that it is likely to succeed on the merits of its infringement case.
Sep 13, 2018
Zydus Cadila gets USFDA nod to market osteoporosis drug; to be manufactured in co's Ahmedabad unitThe drug Risedronate Sodium delayed-release tablets, used for the treatment of osteoporosis in post-menopausal women.
Aug 24, 2018
Lupin gets establishment inspection report from USFDA for its Nagpur facilityEarlier in May, in a regulatory filing Lupin had said that the US health regulator had completed inspection of the Nagpur facility without making any observations.
Aug 22, 2018
Lupin recalls over 11,000 bottles of hypertension drug in US marketLupin's US arm is recalling 11,706 bottles of Lisinopril tablets, used for treating hypertension, from the American market, USFDA said.
Aug 21, 2018
Torrent Pharma recalls 14 lots of blood pressure drug from US market due to presence of impurity"To date, Torrent Pharmaceuticals Ltd has not received any reports of adverse events related to this recall," company said
Jul 26, 2018
Dr Reddy's Labs Q1 net profit increases nearly eight-fold to Rs 456 cr on operational efficiencies, forex gainsShares of Dr Reddys Laboratories closed at Rs 2,134.55 per scrip on BSE, up 2.19 percent from its previous close.
Jul 09, 2018
Pharma sector may post 17% revenue growth in June quarter; domestic growth, currency tailwinds to drive growth: ReportThe domestic pharmaceutical sector accounts for 3.1-3.6 percent of the global pharmaceutical industry in value terms and 10 percent in volume terms.
Jun 25, 2018
Lupin to launch nearly 30 products in US market this fiscal, says managing director Nilesh GuptaLupin currently has 162 abbreviated new drug applications (ANDAs) pending approval with the US Food and Drug Administration (USFDA)