Shilpa Medicare receives European marketing authorization for Tadalafil Orodispersible Films for erectile dysfunction

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.

The facility is involved in manufacturing, packaging, labelling and testing of finished dosage forms (oral dispersible/dissolving Films and Transdermal Patches).

Medical Dialogues team had earlier reported that Shilpa Medicare's Joint Venture Oncosol (50:50 JV with Liqmeds Lifecare Limited, a Zydus group company and Koana Healthcare Limited, Shilpa Medicare group company) along with its partner Shorla Oncology had announced the US Food and Drug Administration (USFDA) approval of IMKELDI (imatinib oral solution), a oral liquid form of imatinib to treat certain forms of leukemia and other cancers.

Read also: Shilpa Medicare-Zydus JV gets USFDA nod for Imkeldi for certain forms of leukemia, other cancers