Remove Containment Remove Contamination Remove Contract Manufacturing Remove Regulation
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HPAPIs – Current Interest of the Pharmaceutical Industry

Roots Analysis

Corticosteroids are produced by adrenal gland and play a role in controlling stress to decrease inflammation whereas, anabolic steroids regulate the manufacturing of testosterone in the testicles and the ovaries. This precaution is taken to prevent any potentially harmful contaminant from escaping the production area.

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FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

billion, primarily driven by Pfizer CentreOne, Pfizer’s contract manufacturing operation, reflecting sales of legacy Upjohn products to Viatris (4) and remdesivir to Gilead Sciences Inc., DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of May 4, 2021.