Shilpa Medicare informed that it has received marketing authorization from Portugal, Europe, for Tadalafil Orodispersible Films, 20 mg.
The approved drug is indicated for the treatment of erectile dysfunction (sometimes called impotence) in adult males. The total Europe market for oral Tadalafil formulations is estimated at about $400 million.The drug maker stated that it 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 Shilpas product is bioequivalent to the reference product.
The approval has been granted for the company's finished dosage form manufacturing facility, Unit VI, located in Dabaspet, Bengaluru, Karnataka. Currently approved by the MHRA UK, this marks the second approval for a prescription oral mouth-dissolving film product in the European/UK regulated markets from this facility. It is involved in the manufacturing, packaging, labeling, and testing of finished dosage forms, including oral dispersible/dissolving films and transdermal patches.
Raichur-based Shilpa Medicare is a vertically integrated manufacturer and distributor of quality drugs to global markets, specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance.
The companys consolidated net profit soared to Rs 17.94 crore in Q2 FY25 as against Rs 1.61 crore posted in Q2 FY24. Revenue from operations rose 9.8% to Rs 343.80 crore in the quarter ended 30 September 2024.
The scrip tumbled 3.85% to currently trade at Rs 778.35 on the BSE.
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