List of Approved Drug Products containing FDA APPLICATION 17064 in the FDA Orange Book on PharmaCompass.com
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations. RLD :No TE Code :AB FENOFIBRATE Brand Name :FENOFIBRATE (MICRONIZED) Dosage Form :CAPSULE;ORAL Dosage Strength :43MG ...
User fees, biosimilars on FDA priority list for 2016Gretchen E. Sherwood
Thanks to over 70 years of experience in process development, scale-up and cGMP manufacturing, we support both emerging and established pharmaceutical customers in the development and commercialization of their small molecule API clinical candidates. At our FDA-approved plant located in Central Europe,...
A new biologic medicine was recently FDA approved to treat acute flares of GPP. It's called spesolimab (Spevigo). But this medicine hasn't been tested in pregnancy. How Does GPP Affect Both Mother and Baby? It can be very dangerous for both of you. For mothers, it can lead to: ...
You joined Junshi in 2018 and led the company to its IPO by the end of the year. But before that, you had a long career with the FDA and Sanofi. What were those experiences like, how did the Junshi opportunity come up, and what ultimately led you to make the move?
User fees, biosimilars on FDA priority list for 2016Erica Cribbs
List of Approved Drug Products containing Amlodipine Besylate in the FDA Orange Book on PharmaCompass.com
List of Approved Drug Products containing Esomeprazole Magnesium in the FDA Orange Book on PharmaCompass.com