Spotlight On... FDA unveils new pharma manufacturing program as part of draft guidance; Jiangsu plans for $3B IPO this year; Kalbe Farma to build facility in West Java; and more...

As part of a draft guidance issued almost two weeks ago, the FDA is asking pharma companies to take part in a program that will review new, cutting-edge pharmaceutical manufacturing technology. The regulatory agency said the program is for companies submitting investigational drug applications, original or supplemental new drug applications, abbreviated new drug applications or biologic license applications. The FDA said it intends to work with companies on a case-by-case basis so that the agency can develop future guidance and standards for emerging manufacturing technology. Companies participating in the program would provide one or more elements that would be subject to quality assessment that the agency has not had any or very little experience with, and "where the technology has the potential to modernize the pharmaceutical manufacturing body of knowledge to support more robust, predictable or cost-effective processes." Article

> Chinese pharmaceutical giant Jiangsu Hansoh, which operates a facility in New Jersey, is planning to raise up to $3 billion in a Hong Kong IPO offering slated for later this year. Article

> Kalbe Farma said it will begin construction on a new biopharmacy raw material facility in Cikarang, West Java, that is scheduled to be being production in late 2017 or early 2018. Announcement

> Remedy Pharmaceuticals, maker of the central nervous system drug, Cirara, said it has named Alan Cutler as vice president of chemistry manufacturing and controls, and Ann Tunstall was appointed as vice president of regulatory and operational affairs. Announcement

 

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