China-based Aurisco Pharmaceutical (SHA: 605116) has announced the successful completion of a current Good Manufacturing Practice (cGMP) inspection by the US Food and Drug Administration (FDA) at its Active Pharmaceutical Ingredient (API) and finished dosage form (FDF) plant located in Yangzhou, Jiangsu province. The inspection confirmed that the site was fully compliant with GMP guidelines, with zero 483 observations issued, indicating no deviations from the required standards.
Ongoing cGMP Status for Aurisco’s Plant
The news reaffirms Aurisco’s ongoing cGMP status for its plant, which had previously been approved by the FDA. This compliance is a testament to the company’s commitment to maintaining the highest standards in manufacturing practices, ensuring the quality and safety of its products.
CDMO Services and Product Range Expansion
Aurisco offers Contract Development and Manufacturing Organization (CDMO) services from its Yangzhou plant, manufacturing generic APIs for a variety of drugs, including dydrogesterone, brivaracetam, bempedoic acid, dolutegravir sodium, rimegepant, and vibegron. The company is also expanding its capabilities to include peptide manufacturing, with the production of semaglutide set to commence imminently.-Fineline Info & Tech
