Hyderabad, India-headquartered Aurobindo Pharma announced that its wholly- owned subsidiary Eugia Pharma Specialties, received final approval from the U.S. Food & Drug Administration to manufacture and market Leuprolide Acetate injection, 14 mg/2.8 mL MDV (Kit). This drug is indicated for the palliative treatment of advanced prostate cancer. The product is...
51 Indian Pharma Companies Get ANDA Approvals
Fifty-one of the 112 approvals for abbreviated new drug applications (ANDA) given by the USFDA went to India. Further, Indian companies received 6 tentative approvals from an aggregate of 23 tentative approvals in the Jan-March quarter of 2018. With eleven ANDA approvals, Aurobindo Pharma received the highest number among the...