Shilpa Medicare receives European marketing authorization for Tadalafil Orodispersible Films for erectile dysfunction
Shilpa Medicare has informed in a BSE filing that the Company has received marketing authorization from Portugal, Europe, for Tadalafil Orodispersible Films, 20 mg.
The total Europe market for oral Tadalafil formulations is estimated at about USD 400 million.
"Shilpa Medicare becomes the first company in the World to receive approval for this product as a convenient, patient friendly oral mouth dissolving/dispersing Film formulation. This approval is a hybrid application and Shilpa’s product is bioequivalent to the reference product," it added.
Tadalafil is indicated for the treatment of erectile dysfunction (sometimes called impotence) in adult males.
This approval has come from the Company’s finished dosage form manufacturing facility, Unit VI, located at Dabaspet, Bengaluru, Karnataka. The facility is currently approved by MHRA UK and this is the second approval for a prescription oral mouth dissolving film product in the European/UK regulated markets from the facility.
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