Shilpa Medicare up on UK nod to market vertigo drug, clearing Japanese inspection

The company received marketing authorization from Medicines and Healthcare Products Regulatory Agency, UK, for Betahistine Dihydrochloride Orodispersible Films, 24 mg

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Shilpa Medicare shares were up 1 percent at Rs 374.95 in the early trade on September 4 after the company said that the UK healthcare products regulatory agency allowed it to market a Meniere’s syndrome drug.

The company also successfully completed an inspection by the Japanese regulatory agency.

The company said its 100 percent subsidiary Shilpa Pharma Lifesciences’ active pharmaceutical ingredient manufacturing facility at Raichur, Karnataka underwent a good manufacturing practice (GMP) inspection by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) starting August 29.

The inspection concluded successfully on September 1 without any critical or major observations. The facility makes various oncology and non‐oncology APIs.

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The company also received marketing authorisation from the Medicines and Healthcare Products Regulatory Agency (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 the UK, the company said.

The approval is for 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 the UK, Europe.

The orally dispersible/dissolvable film formulation offers benefits with respect to patient compliance and ease of administration, the company added.

This approval has come from the company’s finished dosage form manufacturing facility, Shilpa Medicare, 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).

At 10.01 am, the stock was trading at Rs 375.35 on the National Stock Exchange, up 1.31 percent from the previous close.

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