Drug firm AstraZeneca Pharma India today said it has received permission from the Drug Controller General of India (DCGI) to import and market olaparib tablets used for the treatment of ovarian and breast cancer.
The permission from the DCGI is for olaparib (Lynparza) tablets in the strengths of 100 mg and 150 mg, AstraZeneca Pharma India said in a BSE filing.The tablets are a patented product of the AstraZeneca group, it added.
"The import and market permission for olaparib is a significant milestone for women in India living with platinum-sensitive relapsed ovarian cancer and BRCA-mutated HER-2 negative metastatic breast cancer, which has historically been difficulty-to-treat diseases," AstraZeneca Pharma India MD Gagan Singh said.
Shares of AstraZeneca Pharma India yeerdayat Rs 1,710.30 per scrip on BSE, up 1.59 per cent from their previous close.
AstraZeneca India was established in 1979 and is headquartered at Bengaluru, Karnataka. AstraZeneca Pharma India Limited (AZPIL) is the operating company and covers manufacturing, sales and marketing activities of the company in India. It is a listed company and is a subsidiary of AstraZeneca Plc, UK. It has a workforce of over 1400 employees across the country that is committed to deliver life-changing medicines to patients through innovative science and global excellence in development and commercialization. The company has an innovative portfolio in crucial areas of healthcare including cardiovascular, renal & metabolic diseases, oncology and respiratory.
Rated as one of the finest in South East Asia, AstraZeneca’s Indian manufacturing facility has a sophisticated production facility designed to meet the most stringent international standards, conforming to WHO cGMP (current Good Manufacturing Practices) norms. The facility is an ISO 14001 certified company and has a full-fledged environment management system in place.
AstraZeneca India Private Limited (AZIPL) hosts the IT (Global Technology Centre), Global Business Services (Global Commercial Operations) and GMD (Global Medicines Development). AZIPL is governed by a Board of Directors.
Inputs- PTI