AstraZeneca Pharma receives nod from DCGI for Osimertinib tablets
India: AstraZeneca Pharma Limited announced that it has received import and market permission in Form 45 (Marketing Authorisation) from the Drug Controller General of India (DCGI) for Osimertinib tablet 40 mg and 80 mg.
The receipt of the import and market permission pave the way for the launch of Osimertinib tablets (Tagrisso) in India, subject to the receipt of other related statutory approvals and licenses.
Osimertinib (Tagrisso) is the product of AstraZenca group and has been approved in over 45 countries, including US, EU, Japan, China and other Asian Countries.
Osimertinib (Tagrisso) is indicated for the treatment of patients with metastatic epidermal growth factor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an appropriate test, whose disease has progressed on or after EGFR TKI therapy.
Astrazeneca Pharma India Ltd is currently trading at Rs 915, down by Rs 6.95 or 0.75% from its previous closing of Rs 921.95 on the BSE.
The scrip opened at Rs 929.2 and has touched a high and low of Rs 929.3 and Rs 915 respectively. So far 3154(NSE+BSE) shares were traded on the counter. The current market cap of the company is Rs 2304.88 crore.
The BSE group 'B' stock of face value Rs 2 has touched a 52 week high of Rs 1146.95 on 24-Aug-2016 and a 52 week low of Rs 909 on 01-Mar-2017. Last one week high and low of the scrip stood at Rs 957 and Rs 919 respectively.
The promoters holding in the company stood at 75 % while Institutions and Non-Institutions held 11.17 % and 13.83 % respectively.
The stock is currently trading below its 50 DMA.