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 Eugia Pharma Gets USFDA Approval to Make and Market Prostate Cancer Drug
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...
India's Aurobindo Pharma Buys Injectables Assets from Spectrum Pharmaceuticals.
Hyderabad, India-based Aurobindo Pharma will acquire seven branded oncology injectables from Henderson, Nevada-based Spectrum Pharmaceuticals Inc., for about $300 million. Acrotech Biopharma LLC, a wholly-owned subsidiary of Aurobindo Pharma USA Inc., will acquire the assets. The transaction is expected to close within 90 days. The acquisition involves an upfront payment of...
India's Aurobindo to Acquire Drug Under Development from Advent Pharma
Hyderabad, India-based Aurobindo Pharma's U.S. subsidiary Aurobindo Pharma USA Inc signed a pact to acquire an under-development product and certain related assets from Australia's Advent Pharmaceuticals Pty Ltd., for $12.5 million. The time period for completion of the deal is January 2019. Advent is a specialty pharmaceutical R&D company based in Melbourne,...
India's Aurobindo Buys Novartis' Dermatology business
Hyderabad, India-based Aurobindo Pharma signed a definitive agreement to acquire certain assets from Sandoz Inc., U.S.A., a Novartis division, for a consideration of $900 million. The proposed acquisition will be on a debt-free and cash-free basis, and comprises the dermatology business and a portfolio of oral solid products along with commercial...
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...