Alembic Pharma clears USFDA inspection at oncology unit in Panelav Farhat Nasim29 Jun 2019 10:02 AM ISTThis was a first scheduled inspection and Alembic Pharma passed the inspection without any Form 483 Observation.New Delhi: Alembic Pharmaceuticals...
Dr Reddys launches generic version of Tobi in US market Farhat Nasim26 Jun 2019 3:07 PM ISTThe product is a therapeutic equivalent generic version of TOBI (tobramycin) Inhalation Solution, approved by the U.S. Food and Drug Administration...
Alembic Pharma gets USFDA nod for generic version of Tamiflu capsules Farhat Nasim25 Jun 2019 11:54 AM ISTThe approved product, Oseltamivir Phosphate capsule is therapeutically equivalent to the reference listed drug (RLD), Tamiflu Capsules of Hoffman-La...
Dr Reddys gets two USFDA observations for Vizag plants Farhat Nasim24 Jun 2019 11:09 AM ISTHyderabad: City-based Dr Reddy's Laboratories (Dr Reddys/ DRL) has reportedly fallen under the US health regulator's scanner. The company has been...
Cadila Healthcare gets EIR report on Ahmedabad SEZ facility Medical Dialogues Bureau18 Jun 2019 1:57 PM ISTNew Delhi: Drug firm Cadila Healthcare Monday said it has received establishment inspection report from the US health regulator with voluntary action...
Roche gets USFDA nod for combo lymphoma treatment Polivy Medical Dialogues Bureau11 Jun 2019 9:30 AM ISTPolivy was approved in combination with Roche's older drug Rituxan and a chemotherapy agent for adult patients with advanced diffuse large B-cell...
Natco Pharma- Kothur facility gets 9 observations from USFDA Medical Dialogues Bureau7 Jun 2019 2:21 PM ISTNEW DELHI: Natco Pharma Thursday said the US health regulator has made nine observations after the completion of inspection of its Kothur formulation...
Natco Pharma files ANDA for generic version of Bosentan tablets for oral suspension Farhat Nasim5 Jun 2019 10:00 AM ISTBosentan 32 mg tablets are sold by Actelion Pharmaceuticals US, Inc. (acquired by Johnson and Johnson) under the brand name Tracleer.Hyderabad:...
Cadila Healthcare gets 11 USFDA observations for St Louis facilities Farhat Nasim3 Jun 2019 5:23 PM ISTThe United States Food and Drug Administration (USFDA) inspected the manufacturing facilities of Nesher Pharmaceuticals (USA) LLC located at St Louis,...
Cadila Healthcare posts Q4 net profit of Rs 460 crore Medical Dialogues Bureau30 May 2019 9:15 AM ISTThe consolidated financial statements for the quarter and the year ended March 31, 2019, including the operations of Heinz India Pvt Ltd (HIPL) for...
Technical Committee recommends CDSCO to approve import, marketing of Sanofi TB drug with clinical trial waiver Farhat Nasim28 May 2019 4:21 PM ISTNew Delhi: Apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has been recommended by the Techincal Committee to granted...
Granules India gets USFDA nod for Methylphenidate Hydrochloride ER capsules Farhat Nasim28 May 2019 10:00 AM ISTThe approved product, Methylphenidate Hydrochloride extended-release capsules, is bioequivalent to the reference listed drug product (RLD), Ritalin LA...
