Shilpa Medicare Limited, based in Raichur, Karnataka, has achieved a significant milestone by receiving Marketing Authorization from Portugal for its Tadalafil Orodispersible Films (20 mg). This innovative, patient-friendly oral mouth-dissolving film formulation makes Shilpa Medicare the first company worldwide to gain approval for this product.
Tadalafil, a drug used to treat erectile dysfunction, is now available in an easy-to-use orodispersible film form, offering a convenient alternative to traditional tablets. The European market for oral Tadalafil is valued at approximately USD 400 million, presenting a promising opportunity for Shilpa Medicare’s novel formulation.
This approval comes from the company’s state-of-the-art manufacturing facility, Unit VI, located in Dabaspet, Bengaluru, Karnataka. The facility is approved by MHRA UK and has now secured its second approval for prescription oral mouth-dissolving films in regulated European/UK markets. Shilpa’s product is bioequivalent to the reference product and demonstrates the company’s commitment to advancing healthcare with innovative solutions.
In the meantime, Shilpa Medicare shares opened at ₹802.00, with a high of ₹807.35 and a low of ₹780.00. The stock’s 52-week high stands at ₹959.50, while its 52-week low is ₹313.15. As of 2:02 PM, the share were trading 2.01% lower at Rs 792.50.
