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Shilpa Medicare Secures EU Approval for Tadalafil Orodispersible Films

Written by: Team Angel OneUpdated on: Jan 13, 2025, 1:56 PM IST
Shilpa Medicare secures EU approval for Tadalafil Orodispersible Films, a first-of-its-kind bioequivalent, targeting a $400M market.
Shilpa Medicare Secures EU Approval for Tadalafil Orodispersible Films
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Shilpa Medicare Limited, based in Raichur, Karnataka, has secured Marketing Authorization in Portugal, Europe, for its innovative Tadalafil Orodispersible Films (20 mg).  

Shilpa Medicare Achieves Marketing Authorisation in Europe

This groundbreaking approval makes Shilpa Medicare the first company globally to offer this convenient, mouth-dissolving formulation, which is bioequivalent to the reference drug. Approved through a hybrid application process, Tadalafil Orodispersible Films are designed to treat erectile dysfunction in adult males, enhancing patient convenience and usability. With this achievement, Shilpa Medicare taps into the $400 million European market for oral Tadalafil products, marking a significant milestone in pharmaceutical innovation.

Manufacturing Excellence at Bengaluru Facility

The approval for Tadalafil Orodispersible Films originates from Shilpa Medicare’s state-of-the-art Unit VI facility, located at Dabaspet, Bengaluru, Karnataka. This manufacturing plant, which specialises in producing oral dissolving films and transdermal patches, is already accredited by the MHRA (UK). The facility plays a crucial role in the production, packaging, labelling, and quality testing of finished dosage forms, cementing its reputation in regulated European and UK markets.

Market Potential and Innovation

The oral Tadalafil formulations market in Europe is valued at approximately USD 400 million, presenting significant growth opportunities for Shilpa Medicare. With this latest approval, the company sets a new benchmark in pharmaceutical innovation, delivering a user-centric formulation for erectile dysfunction. This marks the second prescription oral dissolving film product approval for Shilpa Medicare’s Unit VI, reflecting the company’s commitment to quality and advanced drug delivery systems.

About Shilpa Medicare Limited 

Shilpa Medicare Limited (SML), founded in 1987 by Vishnukant Bhutada, is an Indian pharmaceutical company specializing in the development, manufacturing, and sale of oncology and non-oncology APIs, formulations, and biosimilars. With five manufacturing facilities, SML supplies to regulated markets across the U.S., Europe, and emerging economies while also offering contract research and manufacturing services.

Shilpa Medicare Share Performance 

As of January 13, 2025, at 9:20 AM, Shilpa Medicare Limited’s shares are trading at ₹767.75, reflecting a 1.21% drop from the previous day’s closing price. Over the past month, the stock has declined by 6.43%, while over the last year, it has decreased by 7.28%. The stock’s 52-week high stands at ₹959 per share, while its 52-week low is ₹316 per share.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. This does not constitute a personal recommendation/investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions. 

Investments in the securities market are subject to market risks, read all the related documents carefully before investing.

Published on: Jan 13, 2025, 1:56 PM IST

Team Angel One

Team Angel One is a group of experienced financial writers that deliver insightful articles on the stock market, IPO, economy, personal finance, commodities and related categories.

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