BD Rx Inc., a wholly-owned subsidiary of leading global medical technology company BD (Becton, Dickinson and Company), reports that the U.S. FDA has approved the second drug provided in the newly launched BD Simplist line of ready-to-administer prefilled generic injectables. The second BD Simplist product to launch is Metoclopramide Injection, USP, an injectable antiemetic, BD Rx reported in a press release. The first drug, BD Simplist Diphenhydramine Hydrochloride Injection, USP, an injectable antihistamine, was launched on March 27, 2013.
Gerresheimer has begun producing components for a new order of insulin pens for Sanofi, Gerresheimer reports. To satisfy the new order, a new production hall was built, qualified, and validated at Gerresheimer’s facility in Horšovský Týn, Czech Republic. The new hall manufactures structural components for the disposable insulin pen, and final pen assembly takes place at Sanofi’s facility in Frankfurt/Main in Germany.
At the European Tube Manufacturers Association's (ETMA) May conference in Brussels Neopac was recognized for Fleximed, a range of transparent, flexible, medical tubes that can be used as alternatives to glass for parenteral packaging. Neopac received the “Tube of the Year 2012“ in the “Prototype” category.
Plan now to visit Pharmapack Europe in Paris February 15-16. For more details on the event, visit www.pharmapack.fr. Hope to see you stop by the PMP News booth!
15th February 2012
9.30: Opening Address
“From Mesopotamia to modern times, THINK DIFFERENT about INNOVATION,” Patrice Noailles, Président, Seillans Investissement, France
One lot of Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package, has been recalled by American Regent because the vials may contain silicone particles, the company reported in a statement posted to FDA's Web site. The lot is #1006, Expiration Date: January 2013, NDC # 0517-3900-25. No other lots or sizes are involved.
SGD's flat-bottom, lighter-weight vials with better glass distribution are now available in 20-, 30-, and 50-ml capacities. The EasyLyo range initially featured 5- and 10-ml versions, and user interest encouraged SGD to expand its offerings.
Technical studies showed that EasyLyo is 5 to 10 times more resistant than a standard vial in terms of vertical load resistance. Twice more resistant again in terms of the radial load resistance: pressure exerted during the loading/unloading in the liophilizator, than a standard vial.
Maik W. Jornitz, group vice president of Global Marketing & Product Management for Filtration/Fermentation Technologies at Sartorius Stedim Biotech, is now chair of the board of the Parenteral Drug Association (PDA). The PDA, headquartered in Bethesda, MD, provides science, technology, and regulatory information and education for the global pharmaceutical and biopharmaceutical community.
Packaging for parenterals allows the user to reconstitute drugs without needles.