BioAlliance Pharma Obtains European Approval for Loramyc Tablet Embossing and Extension of Its Shelf Life to 36 Months
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.
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