SHILPAMED.NSE Shilpa Medicare Ltd.

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 criticalmajor 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 Menieres syndrome and is available as tablets and oral liquid dosage forms in various strengths across UK, Europe. The Orally dispersibledissolvable 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 companys approval is a hybrid product application, which is bioequivalent to the reference product, it added.This approval has come from the companys 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 dispersibledissolving Films and Transdermal Patches). Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated marketsThe companys 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.

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

Shilpa Medicare announced that the Companyfs finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana state has undergone a GMP inspection by ANVISA, Brazil starting 21 August 2023. The inspection has concluded successfully on 24 August 2023 without any observations. The facility is involved in manufacturing, packaging, labelling and testing of finished dosage forms (sterile injections and non]sterile oral solids) for the treatment of various forms of cancer and adjuvant therapy. This inspection is the third major regulatory inspection (after Russia and Canada), cleared by this Site in the past two years. This inspection and subsequent approval will allow the company for the commercial distribution of products in Brazil market and enable approval of new applications for Brazil market.

The facility is involved in manufacturing, packaging, labelling and testing of finished dosage forms (sterile injections and non‐sterile oral solids) for the treatment of various forms of cancer and adjuvant therapy. The inspection was carried from 21 August 2023 to 24 August 2023, the inspection has concluded without any observations.This inspection is the third major regulatory inspection (after Russia and Canada), cleared by this Site in the past two years. This inspection and subsequent approval will allow the company for the commercial distribution of products in Brazil market and enable approval of new applications for Brazil market. The firm said that it remains committed to maintain the GMP status and quality standards as per the expectations and standards of Global Regulatory Authorities. Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated marketsThe companys 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. The scrip declined 0.56% to Rs 363.55 on the BSE.

Shilpa Medicare will hold a meeting of the Board of Directors of the Company on 10 August 2023.