BioAlliance Pharma obtains european approval for Loramyc® tablet embossing and extension of its shelf life to 36 months
9 Jul, 2009
BioAlliance Pharma SA (Euronext Paris: BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced Europe-wide approval for embossing its Loramyc® mucoadhesive buccal tablet, developed for the treatment of oropharyngeal candidiasis.
The embossing process has thus been approved under the Mutual Recognition Procedure; it was first required for the US market, where BioAlliance Pharma submitted a new drug application for Loramyc® to the Food and Drug Administration (FDA) in June 2009. BioAlliance Pharma will be able to harmonize Loramyc® production within those two key markets.
BioAlliance Pharma also received European approval for extension of Loramyc®’s shelf life from 18 to 36 months.
These two key industrial parameters are complementary assets for Loramyc® and will help optimizing manufacturing, storage and distribution costs.