Warning Letter
In a 7 January warning letter,the US Food and Drug Administration's Kansas City district office(Lenexa, KS) cited Omaha's Essential Pharmacy Compounding formass-producing veterinary drugs from bulk active pharmaceuticalingredients. The warning cited large-scale compounding ofaltrenogest, amikacin sulfate, dipyrone, flunixin belumine, ketoprofen,ivermectin, ompeprazole, phenylbutazone, and tripelemine hydrochoride,"among many others."
As is typical in these warnings, the agency voicedconcerns that Essential is compounding not for individual patients butfor third-party resale, and that the compounded drugs duplicateapproved products in dosage and concentration.
Douglas McCormick
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development
March 26th 2024In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.