March 14th 2025
The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
FDA Warning Letter to Lupin Underscores the Need for Top Management Involvement in cGMP Compliance
October 17th 2019Over a two-year period, FDA inspections at company facilities found repeat problems with quality systems including lack of written procedures, inadequate investigation of out-of-specification conditions and corrective and preventive action, and insufficient cleaning and cleaning validation.
FDA cites repeated, fundamental cGMP issues in its warning letter to Torrent Pharmaceuticals
October 17th 2019Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.
FDA Issues Complete Response Letter for AstraZeneca COPD Drug Application
October 1st 2019AstraZeneca has received a complete response letter from FDA regarding its new drug application for a budesonide/glycopyrronium/formoterol fumarate triple-combination therapy for treating chronic obstructive pulmonary disease.
FDA Gains Approval to Revamp New Drug Review Operations
September 27th 2019After months of planning and explaining, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs.
New Virtual Reality Platform Offers Life Sciences Industry Training
September 27th 2019A new educational platform by Quality Executive Partners offers on-demand digital courses with technical content, virtual reality, and real-time coaching with an initial focus on sterile product manufacturing and microbiology.
AstraZeneca’s Combination Diabetes Pill Recommended for Approval in EU
September 23rd 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of AstraZeneca’s Qtrilmet (metformin hydrochloride, saxagliptin, and dapagliflozin) modified-release tablets for treating type-2 diabetes.
CHMP Grants Positive Opinion for Pfizer/Merck KGaA Cancer Drug Plus Axitinib for Kidney Cancer
September 23rd 2019The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion recommending marketing authorization for Bavencio (avelumab) in combination with axitinib for treating kidney cancer.