Mylan Initiates Nationwide Recall of 15 Lots of Valsartan Tablets
Mylan Pharmaceuticals is conducting a voluntary nationwide recall of select lots of Valsartan-containing products due to trace amounts of an impurity, N-nitrosodiethylamine (NDEA), contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human…
Drug Recalls Increased, Medical Device Recalls Decreased in Q3
In the third quarter of 2018, faulty manufacturing practices had an impact on the pharmaceutical industry, according to the latest Recall Index released November 13 by Stericycle Expert Solutions. Drug recalls increased 19 percent to 92, though recalled units declined 56 percent to just over 7 million; lower than 10 of the last 13 quarters. Failed specifications…
FDA Drug Shortages and Discontinuations: 11/12/18 Update
Hikma and Vectura to Produce Generic Versions of GSK’s Ellipta Meds
AstraZeneca Sheds Rights to Three Respiratory Drugs for $350M
AstraZeneca has agreed to sell rights outside the U.S. for respiratory drugs Alvesco, Omnaris, and Zetonna to Zug, Switzerland-based Covis Pharma B.V., which acquired the U.S. rights for the drugs in 2017. Covis will become the owner of the medicines upon closing. Covis Pharma will pay AstraZeneca $350 million in addition to conditional sales-related payments of up to $21 million over four years starting in 2019.…
Quanticate Expands Presence in India
Biospecimen Exchange Upgrades Platform to Fuel Broader Specimen Sharing
INTERPHEX Extends Deadline for Speaker Abstract Submissions
INTERPHEX, the 40th annual International Pharmaceutical Expo set for April 2-4 in New York, has extended the deadline for speaker abstracts until November 8. The conference focus for the 2019 event, “Human Interface in the Science of the Pharma and Bio Supply Chain,” will feature several session tracks, including: Integrating Human Interface into Smart Manufacturing Ensuring Alignment of…
Experic Launches With Planned cGMP Pharma Supply Facility in New Jersey
Experic, a pharmaceutical supply services provider, has leased a 45,500-square-foot headquarters, research, manufacturing, and packaging facility in Cranbury, NJ. to focus on small and midsize customers. The new cGMP facility will feature capabilities around powder and solid oral manufacturing in addition to traditional dosage forms, along with packaging, labeling, and global supply chain management services. Upon opening, the facility…