In December, the Food and Drug Administration issued a thorough inspection report on PharMEDium’s Tennessee plant that resulted in a pause in pharmaceutical production, until otherwise permitted. PharMEDium, one of the nation’s largest compounding pharmacy companies, is owned by AmerisourceBergen. It supplies medications to about 77% of hospitals nationwide.
The new, state-of-the-art manufacturing facility, operated by Heritage Pharma Labs Inc. (“Heritage Pharma Labs”), consists of dispensaries/pharmacies and multiple manufacturing suites to hold fixed and portable equipment to perform pharmaceutical operations like mixing, granulation, drying, milling/sieving, compaction, extrusion/spheronization, blending, compression, coating, encapsulation and packaging
Novartis announced today, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA subject to certain conditions. Advanced Accelerator Applications (NASDAQ:AAAP) is a radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicines including Lutathera®
AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain. The US Food and Drug Administration (FDA) has granted priority review to AbbVie’s investigational candidate, elagolix, for the management of endometriosis with associated pain. Endometriosis is characterised by long-term pelvic pain and caused by tissue growth outside of the uterus.
Equashield will invest an estimated $30 million to build the new plant to meet the growing market demand for manual and automated hazardous drug compounding devices.
USP General Chapter <797> provides standards for compounding sterile preparations to promote patient safety and prevent harm. These standards help ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency.
