Aurobindo Pharma Unit-7 documents inaccurate, misleading: USFDA Medical Dialogues Bureau11 Oct 2019 10:00 AM IST"The responsibilities and procedures applicable to the quality control unit are not fully followed. Several lists of documents requested were either...
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...
Roche gets USFDA clearance for cobas pro solutions for diagnostics labs Medical Dialogues Bureau17 Sept 2019 9:15 AM ISTWith the cobas pro integrated solutions, laboratories are now able to run tests faster on less equipment, automate manual tasks and deliver results...
Laurus Labs gets USFDA Establishment Inspection Report for Visakhapatnam units Medical Dialogues Bureau6 Sept 2019 1:03 PM ISTThe establishment inspection report (EIR) from US Food and Drug Administration (USFDA) is for company's active pharmaceutical ingredients units 1 and...
Strides Pharma acquires manufacturing plant in Florida for Rs 3.59 crore Farhat Nasim27 Aug 2019 2:30 PM IST"Strides Pharma Inc has acquired the manufacturing facility under an asset purchase agreement with Micelle Biopharma Inc for a consideration of USD...
Emcure Pharma gets USFDA Warning Letter for Manufacturing Violations at Pune plant Medical Dialogues Bureau16 Aug 2019 9:45 AM ISTIn the letter, the USFDA said inspectors during February 11-20 this year found significant deviations from standard manufacturing practices at Emcure...
Radiation Protection absolute necessity for Medical Professionals- Mr Satyaki Banerjee, CEO, Kiran Medical Systems, Trivitron Healthcare Deepanjana Sarkar Sarkar9 Aug 2019 3:39 PM ISTNew Delhi: In hospitals and diagnostic centers, healthcare providers need to work with various ionizing radiation emitting medical equipment to...
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...
Yet another Cancer Causing impurity flagged in blood pressure drug Valsartan Medical Dialogues Bureau19 Jun 2019 12:01 PM ISTOnline pharmacy Valisure reported that it found a new cancer-causing impurity in some versions of widely prescribed blood pressure medicine valsartan,...
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...
Pfizer gets USFDA approval for Fragmin to treat blood clot in pediatric patients Farhat Nasim19 May 2019 9:45 AM ISTThe efficacy of Fragmin in children was based on a single trial with 38 pediatric patients with symptomatic deep vein thrombosis and/or pulmonary...
Cipla gets no USFDA observations for Indore facility Farhat Nasim18 May 2019 9:45 AM ISTThe US health regulator conducted a post-approval inspection at Cipla Ltd's Indore facility from 13th May to 17th May 2019. New Delhi: Drug firm Cipla...
