10% of drugs sold around the world are fake. Counterfeit medicines are the cause of on average 1 million deaths yearly. Increasing of online purchases and disrupted supply chains have intensified and made the risk of counterfeit medicines due to COVID-19. Drugs are “tracked” once after the product has left the manufacturer and landed where…
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Sagent Pharmaceuticals, Inc. Issues Nationwide Recall
November 19, 2021, Sagent Pharma announces a voluntary nationwide recall of Levetiracetam Injection. Four lots of Levetiracetam was recalled due to the lack of a sterile product. Issues pertaining to container closure integrity was brought to attention when found in reserve sample vials. Sagent Pharmaceuticals did not follow USP suggested guidelines for container closure integrity—distributing…
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Keys to a Successful Rapid Commercial Launch
In manufacturing, pharmaceutical companies’ drugs are produced in hopes to save patients as fast as they can. It is a “race to the finish” pharmaceutical online stated. Getting the drug products produced and sent out to patients as fast as possible is every manufactures goal. The third highest number of drug approvals in over twenty…
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Is Your Sterile Injectable Ready for Changes in Raw Materials?
In any manufacturing company, it is likely that raw material will change from time to time. These changes are modifications in API synthesis, key starter materials and intermediates. These changes are expected and necessary for manufacturing improvement. The best approach to alternating materials from a supplier, is to always keep track and maintain data and…
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