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Shilpa Medicare Files First Transdermal Patch ANDA in US for Rotigotine

Story Highlights
  • Shilpa Medicare has filed its first USFDA ANDA for Rotigotine transdermal patches, a generic Neupro.
  • The complex patch filing from its approved Bengaluru unit boosts Shilpa’s US presence in advanced generics.
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Shilpa Medicare Files First Transdermal Patch ANDA in US for Rotigotine

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The latest announcement is out from Shilpa Medicare Limited ( (IN:SHILPAMED) ).

Shilpa Medicare has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for Rotigotine transdermal patches in multiple strengths, its first-ever transdermal patch submission to the US market and a generic version of Neupro indicated for Parkinson’s disease and Restless Legs Syndrome in a US market estimated at about $112 million. The filing, originating from the company’s USFDA- and Europe-approved Unit VI facility near Bengaluru that manufactures specialized dosage forms including transdermal patches and oral mouth-dissolving films, marks a strategic milestone that deepens Shilpa’s presence in complex generics and advanced drug delivery systems, potentially strengthening its competitive positioning in the US pharmaceutical market and expanding treatment options for neurological patients.

More about Shilpa Medicare Limited

Shilpa Medicare Limited is a leading Indian pharmaceutical company specializing in the development, manufacture and marketing of active pharmaceutical ingredients (APIs), finished formulations and biologics, with a focus on oncology, infectious diseases and specialty segments. Leveraging expertise in complex generics, novel drug delivery systems and contract development and manufacturing (CDMO) services, the company serves patients in more than 80 countries through a portfolio that includes advanced dosage forms such as oral dispersible films and transdermal systems.

Average Trading Volume: 13,695

Technical Sentiment Signal: Hold

Current Market Cap: 61.08B INR

See more data about SHILPAMED stock on TipRanks’ Stock Analysis page.

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