EU Proposes Recall Of Clopidogrel Because Of GMP Failures At Indian Glochem
This article was originally published in PharmAsia News
Executive Summary
Swiss company Acino Pharma says it is unnecessary to recall its generic clopidogrel products from the EU market, even though its Indian API supplier, Glochem Industries, failed a good manufacturing practices inspection
You may also be interested in...
14 Months After U.S. FDA Charged India's Lupin, Manufacturing Facility At Mandideep Cleared
MUMBAI - A long trail of hair splitting audits and investigations came to an end for India's drug maker Lupin as U.S. FDA issued an "All Clear" statement for the company's Mandideep manufacturing site in the central Indian state of Madhya Pradesh
Pipeline Watch: Phase III Readouts in Wilson Disease, Parkinson's Disease And COVID-19
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
AZ's Rare Disease Unit Reports Positive Phase III Results For Copper-Binding ALXN1840
Alexion/AstraZeneca has announced positive top-line results from the Phase III study of ALXN1840 in patients with the rare genetic disorder, Wilson disease, including in patients already on standard-of-care therapies. The compound is ahead of two candidate gene therapies from other companies at early-stage clinical development.