In an exchange filing, the pharma company said that Shilpa Pharma Lifesciences' active pharmaceutical ingredient (API) manufacturing facility, Unit II, situated at Raichur in Karnataka state has undergone a GMP inspection by Pharmaceuticals and Medical Devices Agency (PMDA), Japan starting 29 August 2023.

The inspection has concluded successfully on 1 September 2023 without any critical/major observation, it added.

The facility is involved in manufacturing various oncology and non‐oncology APIs.

The company stated that it remains committed to maintain the GMP status and quality standards as per the expectations and standards of Global Regulatory Authorities.

Meanwhile, Shilpa Medicare informed that it has received marketing authorization from Medicines and Healthcare Products Regulatory Agency (MHRA), UK, for Betahistine Dihydrochloride Orodispersible Films, 24 mg.

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.

The drug maker said that it is the first company to receive approval for the 24 mg strength as a Film formulation in UK. The company's approval is a hybrid product application, which is bioequivalent to the reference product, it 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).

Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated markets

The company's consolidated net profit jumped 38.8% to Rs 1.18 crore as compared with Rs 0.85 crore in Q1 FY23. Net sales fell 0.4% year on year to Rs 260.17 crore in Q1 FY24.

Shares of Shilpa Medicare gained 0.98% to Rs 374.60 on the BSE.