The F.D.A's Center for Devices and Radiological Health designated an invention developed by Dr. Rajah Vijay Kumar as a "breakthrough device" in the treatment of liver, pancreatic, and breast cancers. Gaithersburg, MD-based Shreis Scalene Sciences LLC presented the device to the USFDA which released a communique that said, "We are...
India’s Sun Pharma to Distribute Bayer’s Renal Drug
India's Sun Pharmaceutical Industries Limited and Bayer have signed an agreement allowing Sun Pharma to market and distribute a second brand of the drug finerenone in India under the brand name Lyvelsa. Finerenone is a patented medicine indicated to reduce the risk of sustained decline in kidney function, end-stage kidney...
India’s Glenmark Gets USFDA Approval for Generic Diabetes Medication
Mumbai headquartered Glenmark Pharmaceuticals Ltd announced that its U.S. subsidiary Glenmark Pharmaceuticals Inc, USA, received the second tentative approval from the United States Food and Drug Administration to market a generic medication to treat diabetes in the American market. The drug is Saxagliptin, which is the generic version of Onglyza...
Aurobindo Pharma Gets USFDA Nod for Prostate Cancer Drug
Hyderabad, India-based Aurobindo Pharma announced that its wholly owned subsidiary Eugia Pharma Specialties, received a final approval from the U.S. Food & Drug Administration to manufacture and market Leuprolide Acetate Injection. Injectables This drug is used in palliative treatment of advance prostatic cancer. It had an estimated market size of $83...
India's Pharmaceutical Exports to Cross $19 Billion This Year
According to India's state owned Pharmaceutical Export Promotion Council’s year-end report, pharma exports from the country are expected to reach $19.1 billion during the current fiscal year -- despite muted growth in the North American markets -- a growth of 10.72 percent over $17.28 billion in pharma exports last year....
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...