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...
Dr Reddys gets 8 USFDA observations for Duvvada facility in Andhra Pradesh Medical Dialogues Bureau21 Aug 2019 4:30 AM GMTThe audit of Dr Reddy's formulations manufacturing plant (Vizag SEZ Plant 1) at Duvvada, Visakhapatnam by the United States Food and Drug...
Cadila Healthcare gets OAI letter from USFDA for Moraiya facility Medical Dialogues Bureau8 Aug 2019 4:30 AM GMTThe company has received a letter from the USFDA classifying the inspection conducted at its Moraiya facility from April 22 to May 3 as OAI, Cadila...
Fortis Healthcare reports profit of Rs 78 crore for June quarter Farhat Nasim7 Aug 2019 3:46 AM GMTGross debt was reduced from Rs 1,657 crore in the first quarter of 2018-19 to Rs 1,388 crore in April-June 2019-20 reflecting a robust net debt to...
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...
Zydus Cadila completes phase III trial of Diabetes drug Lipaglyn in India Medical Dialogues Bureau5 Aug 2019 4:30 AM GMTSaroglitazar Magnesium was launched in India during September 2013, under the brand name 'Lipaglyn', for the treatment of hypertriglyceridemia and...
Zydus Cadila wins USFDA nod for Minocycline Hydrochloride ER tablets to treat acne Medical Dialogues Bureau3 Aug 2019 4:15 AM GMTMinocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-modular moderate to severe acne vulgaris in...
Shilpa Medicare gets 5 USFDA observations for Raichur facility Medical Dialogues Bureau31 July 2019 4:00 AM GMT"We have received Form 483 with five observations, with no repeat observations and any data integrity observations. The observations are mostly...
Zydus Cadila launches Ramelteon tablets in US to treat insomnia Medical Dialogues Bureau25 July 2019 5:53 AM GMTIn a BSE filing, Zydus Cadila announced the "launch of Ramelteon tablets, 8 mg upon receiving the final approval from the USFDA. Ramelteon is a...
Torrent Pharma Q1 net profit up 33 percent to Rs 216 crore Medical Dialogues Bureau24 July 2019 4:00 AM GMTThe firm's India business was up nine per cent year-on-year to Rs 907 crore for the quarter. The US revenues at Rs 376 crore were up by 13 per cent...
Laurus Labs, Rising Pharma launches neuropathic pain capsules in US Medical Dialogues Bureau23 July 2019 4:00 AM GMTRising Pharmaceuticals has launched a generic version of Lyrica capsules, in the strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and...
Zydus Cadila arm gets USFDA nod for generic version of Adderall XR capsules in US Medical Dialogues Bureau21 July 2019 4:30 AM GMTThe product is a generic version of Adderall XR capsules and will be manufactured at Nesher Pharmaceuticals' manufacturing facility at St Louis in the...
