Bullish on Thrombin-JMI, King Ramps Up Sales, Production
This article was originally published in The Pink Sheet Daily
King prepares to grow demand for the bovine thrombin in the “under-penetrated” market for topical hemostatic agents.
You may also be interested in...
FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.
Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.
Company’s promise to be more forthright, along with quality culture and policy upgrades, may have helped sway agency.