Cadila Healthcare’s manufacturing facility Alidac Pharmaceuticals Ltd. (Alidac), located at Pharmez, Ahmedabad, has received an establishment inspection report (EIR). The USFDA had conducted a pre-approval inspection (PAI) for doxorubicin liposomal, a complex oncological injectable at Alidac, the injectable onco manufacturing facility, from March 18 to March 26, 2019. There was also a separate in-vitro BE inspection conducted by the Office of Study Integrity and Surveillance branch of the USFDA for the same product.
Besides, the company also informed that Zydus’ Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA, has received the final approval from the USFDA to market Omega-3-acid ethyl esters capsules USP (US RLD – Lovaza capsules), 1 gram. Omega-3 acid ethyl ester, a type of fat found in fish oil, is used along with diet and exercise to help lower levels of certain blood fat (triglyceride). It may also raise good-cholesterol (HDL). The drug will be manufactured at Nesher Pharmaceuticals’ manufacturing facility located at St. Louis, MO, US.