Shilpa Medicare receives UK-MHRA marketing nod for Betahistine Dihydrochloride Orodispersible Films

Karnataka: Shilpa Medicare Limited has received Marketing Authorization from MHRA, UK, for Betahistine Dihydrochloride Orodispersible Films, 24 mg.

"Shilpa is the first company to receive approval for the 24 mg strength as a Film formulation in UK," the company stated in a recent BSE filing. Shilpa’s approval is a hybrid product application, which is bioequivalent to the reference product.

Betahistine is indicated for the treatment of vertigo, tinnitus, hearing loss and nausea associated with Meniere’s syndrome and is available as tablets and oral liquid dosage forms in various strengths across UK, Europe. The Orally dispersible/dissolvable film formulation offers benefits with respect to patient compliance and ease of administration.

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This approval has come from the Company’s finished dosage form manufacturing facility, Shilpa Medicare Ltd, Unit VI, located at Dabaspet, Bengaluru, Karnataka. The facility is approved by MHRA UK and this is the first approval for a prescription Oral Film product in regulated market from this facility. The facility is involved in manufacturing, packaging, labelling and testing of finished dosage forms (oral dispersible/dissolving Films and Transdermal Patches).

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