AstraZeneca Pharma India has received permission to import for sale and distribution of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution for infusion (Imfinzi) from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India for the below mentioned additional indication:
Durvalumab (IMFINZI) in combination with chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, is indicated for the treatment of patients with resectable (tumours 4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
The receipt of this permission paves way for the launch of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution for infusion (Imfinzi) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.
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.
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