Shilpa Medicare gained nearly 3 percent in morning trade on Monday, to its highest level since October 2022, after the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) allowed the company to sell Betahistine Dihydrochloride Orodispersible Films, a drug used for treating hearing loss.
In a filing to the stock exchanges on Friday, the Hyderabad-based Shilpa Medicare said it is the first company to get approval for the 24 milligram strength as a film formulation in the UK. The supply will go from its plant in Dabaspet, Bengaluru in Karnataka.
Orodispersible films allow compliance as well as ease of administration. Betahistine is used for the treatment of vertigo, tinnitus, hearing loss, and nausea associated with Meniere’s syndrome. This is available in tablets and oral liquid dosage forms in several strengths across the UK and Europe.
Separately, the company (market value of over Rs 3,200 crore) announced that its subsidiary, Shilpa Pharma Lifesciences Ltd's active pharmaceutical ingredient (API) manufacturing facility at Raichur in Karnataka has undergone a GMP (Good Manufacturing Practices) inspection by PMDA, Japan.
The inspection began on August 29 and concluded on September 1 without any critical observation.
The Karnataka-based firm said that it remains committed to maintaining the GMP status and quality standards as per the expectations and standards of global regulatory authorities.
Shares of Shilpa Medicare were trading 0.98 percent higher at Rs 374.60 apiece on BSE on Monday at 9:56 AM. The stock is up over 34 percent this year so far but slightly below (about 2 percent) the price it was trading at, this time last year.
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