External manufacturing plays a crucial role in pharmaceutical companies’ supply strategy. The author examines market trends for the captive and merchant global market for active pharmaceutical ingredients and intermediates.
Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The author, Marga Vines from Grifols International, analyzes a project for an injectable drug for which a new drug application was submitted to FDA.
Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party to be in keeping with quality risk-management principles.
Rx-360, a pharmaceutical industry supply-chain consortium, is advancing approaches between pharmaceutical companies, suppliers, and contract manufacturers to better secure the pharmaceutical supply chain.
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?