Drug firm Shilpa Medicare Ltd on Friday (September 1) said it has secured marketing authorisation from MHRA in the United Kingdom for their Betahistine Dihydrochloride Orodispersible Films, 24 mg.
MHRA is the Medicines and Healthcare products Regulatory Agency.
This achievement marks Shilpa as the pioneering company to gain approval for this unique 24 mg strength in film formulation in the UK. The approval falls under the category of a hybrid product application, demonstrating bioequivalence to the reference product.
Betahistine Dihydrochloride is a pharmaceutical compound with diverse applications, particularly in the treatment of vertigo, tinnitus, hearing loss, and nausea associated with Meniere's syndrome.
Traditionally available in tablet and oral liquid forms in various strengths across the UK and Europe, Shilpa's film formulation introduces new advantages in terms of patient compliance and ease of administration.
This significant approval stems from Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit VI, located in Dabaspet, Bengaluru, Karnataka.
Notably, this facility holds approval from MHRA UK, and this marks the facility's maiden approval for a prescription oral film product within regulated markets.
The Dabaspet facility plays a pivotal role in the manufacturing, packaging, labeling, and testing of finished dosage forms, including oral dispersible and dissolving films, as well as transdermal patches.
Shares of Shilpa Medicare Ltd ended at Rs 371.15, up by Rs 1.45, or 0.39 percent on the BSE.
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