Cadila Healthcare to sell right of cholesterol-lowering drug Zypitamag for Rs 49 crore Farhat Nasim1 Oct 2019 2:13 PM ISTThe 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 Sept 2019 10:15 AM IST"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 Sept 2019 11:59 AM ISTThe 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 Sept 2019 5:01 PM ISTThe company has launched Bupropion hydrochloride extended-release tablets USP (SR), approved by the United States Food and Drug Administration...
Granules India gets 2 USFDA observations for Chantilly facility Medical Dialogues Bureau23 Aug 2019 11:46 AM IST"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 10:00 AM ISTThe 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 10:00 AM ISTThe 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 9:16 AM ISTGross 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 4:35 PM ISTNew 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 10:00 AM ISTSaroglitazar 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 9:45 AM ISTMinocycline 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 9:30 AM IST"We have received Form 483 with five observations, with no repeat observations and any data integrity observations. The observations are mostly...
