Mumbai-based Svizera Labs has been suspended as a supplier for TB drugs to a World Health Organization-sponsored program, Reuters reported, as manufacturing quality standards remain unreliable following a September notice on operations.
Mumbai-based Lupin Pharmaceuticals has been hauled up by the U.S. FDA on a manufacturing operation, this time at its Goa plant for failure to meet 9 areas of operating standards.
China FDA has said that generic drugs need to show bioequivalence to the related branded products, adding that the current use of locally made generics will no longer suffice.
India has not taken a decision on a new round of drug price controls as it talks with industry, civil society groups and other stakeholders, junior minister for the Chemicals and Fertilisers Ministry Hansraj Gangaram Ahir said.
Hyderabad-based Dr. Reddy's Laboratories has signed a deal with TR-Pharm to develop and manufacture three unspecified biosimilars, presumably from the India company's existing product and pipeline stable.
Questions are being raised and quick answers sought about the next steps on fake drug monitoring in the wake of China FDA's move to place implementation of its barcode system designed by a unit of Alibaba Group on a moratorium.
Shanghai-based WuXi AppTec said its Shanghai SynTheAll Pharmaceutical's Changzhou facility started initial operations in February, showcasing manufacturing and clinical prowess and speed that can attract investors in China and abroad.
China FDA said it plans to get more innovative new drugs approved faster by identifying clear clinical need as a priority even as the number of approvals dipped last year.
India-based drug companies spent $1.5 billion to buy U.S. firms in 2015 as part of an M&A; effort focused on securing manufacturing facilities abroad as troubles at home mounted with a deluge of U.S. FDA actions that shut exports.
Foreign regulators and domestic producers in India are stepping into the breach to help the country improve its quality-control standards that have been the target in recent months of warning letters and outright bans for manufacturing shortfalls and in some cases fraud.