PharmaCyte Biotech Inc (PMCB)

[efood125]

Austrianova announced today that it has received a United States of America (US) Food and Drug Administration (FDA) Establishment Identifier (FEI) number for its Good Manufacturing Production (GMP) manufacturing facility in Thailand. An FEI number is a mandatory requirement for manufacturers and distributors who plan to market their products in the USA. Facilities that manufacture Active Pharmaceutical Ingredient, cell therapy products and Finished Dosage Forms, like Austrianova need FEI registration. In addition to the FEI, Austrianova already has a D-U-N-S Number, which is a copyrighted proprietary means of identifying business entities on a location specific basis, another requirement by the US FDA.

Rahul Pawa, Austrianova’s Chief Production Officer, stated “We are pleased to announce this important step in compliance with the US FDA requirements. We already announced some months ago that we filed a Drug Master File with the US FDA for encapsulated cell products. This moves us further along on our path to commercial products in the US.”