Granules India recalls over 2.3 cr ranitidine tablets from US market Farhat Nasim13 Jan 2020 11:59 AM ISTNew Delhi: Drug firm Granules India is recalling over 2.3 crore ranitidine tablets, used to treat ulcers of the stomach and intestines, from the US...
Centaur Pharma Ambernath facility receives EIR from USFDA Farhat Nasim28 Nov 2019 9:30 AM ISTCentaur Pharma has now received a formal EIR (Establishment Inspection Report) from USFDA stating the facility is CGMP compliant and the audit outcome...
Cadila Healthcare largest API manufacturing site clears USFDA inspection Medical Dialogues Bureau12 Oct 2019 11:41 AM ISTThe US Food and Drug Administration (USFDA) inspected the company's active pharmaceutical ingredients (API) manufacturing facility at Dabhasa from...
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...
Aurobindo Pharma Unit-7 gets 7 USFDA observations Medical Dialogues Bureau8 Oct 2019 2:54 PM ISTThe United States Food and Drug Administration (USFDA) conducted a Current Good Manufacturing Practices (CGMP) inspection at the company's unit-7...
Cipla gets 12 USFDA observations for Goa facility Medical Dialogues Bureau30 Sept 2019 3:15 PM IST"The United States Food and Drug Administration (USFDA) conducted a cGMP inspection at our Goa manufacturing facility from September 16-27, 2019,"...
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...
Indoco Remedies receives EIR from USFDA for sterile, solid dosages facility in Goa Medical Dialogues Bureau27 July 2019 9:45 AM ISTThe inspection was held from May 27-June 4, 2019 and the company received four Form 483 observations, Indoco Remedies said in a filing to BSE.NEW...
Indoco Remedies gets USFDA warning letter for significant violations at Goa facility Medical Dialogues Bureau26 July 2019 9:30 AM ISTStating the specific violations, the US Food and Drug Administration (USFDA) said Indoco Remedies failed to prepare batch production and control...
Strides Pharma found destroying, dumping drug production documents: USFDA Investigation Medical Dialogues Bureau20 July 2019 2:16 PM ISTIn the letter to Strides Pharma, the FDA didn't explain whether its inspectors often check scrap yards or shredding rooms for documents, or whether it...
USFDA issues warning letter to Indoco Remedies for Goa plant Medical Dialogues Bureau16 July 2019 11:39 AM ISTThe facility had received six observations in Form 483s and was classified as Official Action Indicated in March. Indoco Remedies responded to these...
Hetero Labs recalls over 15.90 lakh bottles of hypertension drug from US Ruby Khatun Khatun30 Aug 2018 11:26 AM ISTNew Delhi: Drug firm Hetero Labs is recalling over 15.90 lakh bottles of Valsartan Tablets used for the treatment of hypertension from the American...
