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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 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.
The scrip declined 0.56% to Rs 363.55 on the BSE.
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