AMRI gets first product approval out of Massachusetts aseptic fill finish site
First alcohol-free formulation provides US patients with alternative to traditional Docetaxel Injection treatment
AMRI has announced that Docetaxel Injection (non-alcohol formula) has been approved for commercial manufacture at its Burlington, Massachussets, aseptic fill-and-finish facility following the US Food and Drug Administration's pre-approval inspection for this drug product.
Eagle Pharmaceuticals, which entered into an exclusive licensing agreement with Teikoku Pharma USA in October 2015 to market, sell and distribute Docetaxel Injection in the US, announced the FDA's US approval of Docetaxel Injection in December 2015. Docetaxel Injection is the first alcohol-free formulation approved in the US for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.
'AMRI is excited to have been able to work with Eagle to meet this important unmet medical need in the market,' said William S. Marth, President and CEO of AMRI. 'The Docetaxel non-alcohol drug product attributes, as well as the manufacturing process itself, are considered to be both unique and challenging with the process containing several critical process control parameters. This commercial scale process has been successfully developed and validated at the AMRI Burlington facility.'
AMRI provides integrated development, formulation, and commercial parenteral solutions, which includes pre-formulation, formulation and process development; cGMP injectable formulation development and clinical drug product; and late phase and commercial parenteral manufacturing. AMRI's Burlington facility is expertly equipped to provide formulation development, cGMP manufacturing and sterile filling of parenteral drugs – including both small molecule drug products as well as biologicals – using various specialized technologies.