Astrazeneca Pharma India said that it has received import and market permission in Form CT-20 from the Drugs Controller General of India (DGCI) for Selumetinib 10 mg & 25 mg capsule.
Selumetinib 10 mg & 25 mg capsule is indicated for treatment of Pediatric patients 3 years of age and older with neurofibromatosis type 1 (NF1) and who have symptomatic, inoperable plexiform neurofibromas (PN).
The receipt of this permission paves way for the launch of Selumetinib 10 mg & 25 mg capsule in India, subject to the receipt of related statutory approvals and licenses, the pharmaceutical company said in a statement. The announcement was made on Sunday (26 September 2021).
AstraZeneca Pharma India is a global biopharmaceutical company. The company is engaged in the discovery, development and commercialization of medicines for core areas of healthcare, including cardiovascular/metabolic disease, cancer and respiratory, inflammatory and autoimmune disease. The company operates through two segments Healthcare and Clinical Trial.
The company's net profit declined 45% to Rs 10.24 crore on a 9.4% fall in net sales to Rs 175.40 crore in Q1 FY22 over Q1 FY21.
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