Date: 2015-11-16
Type of information: Validation of a production plant
Compound: Baxalta Singapore Facility
Company: Baxalta (USA - IL)
Therapeutic area: Rare diseases - Genetic diseases - Hematological diseases
Type agreement: validation of a production plant
Action mechanism:
Disease:
Details: * On November 16, 2015, Baxalta announced that its state-of-the-art recombinant biologic manufacturing facility in Singapore received FDA approval to produce Advate® [Antihemophilic Factor (Recombinant)] bulk drug substance (BDS). The site received regulatory approval from the European Medicines Agency in January 2014 for the production of Advate®. The FDA’s approval comes after a successful filing and site audit with zero observations, confirming that the site complies with the highest quality standards set by the agency and Good Manufacturing Processes (GMP). This approval is a key milestone in Baxalta’s manufacturing strategy, enabling continued growth of the global Factor VIII portfolio, including Advate® and additional investigational treatments, identical in each Baxalta manufacturing facility in which it is produced.
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