Facility features LED lighting, solar panels, automation and innovative temperature-controlled systems to maximize efficiency and minimize environmental impact
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs
Dr Rupali Paranjape, an experienced regulatory and compliance consultant and author of Blue Ocean of Compliance shares insights on her book in an interview with Thomas C Thottathil, Editor, www.indianpharmapost.com
PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection
Expansion of leading biomarker and bioanalysis company enhances bioanalytical solutions for targeted radiopharmaceuticals
This new fund is amongst the largest for the sector in India
The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days
Upon closing, the Quakertown business will become an independent company called Microsize
The new hub, which brings Avantor solutions closer to regional customers and strengthens global supply chain capabilities, will be fully operational early next year
The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency
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