Three Indian firms get USFDA nod for cholesterol drug
The Dollar Business Bureau Three Indian companies, Aurobindo Pharma, Glenmark and Sun Pharma, have got the approval from the USFDA (United States Food and Drug Administration) to sell the generic versions of the famous drug Crestor prescribed for cholesterol, in the US market. The nod, given by the US health regulator to these three domestic companies, is for the generic rosuvastatin calcium tablets in 5 mg, 10 mg, 20 mg and 40 mg strengths. “We are one of the first ANDA (Abbreviated New Drug Application) applicants to file a significantly complete application with a paragraph IV certification. Hence, we are eligible for six months shared exclusivity of the generic drug. The drug is launched in the American market,” Aurobindo ...
Pharmexcil welcomes foreign investments in pharma sector
Jayarama Emani | The Dollar Business The Pharmaceutical Export Promotion Council of India (Pharmexcil), welcomed the move by The Cabinet Committee on Economic Affairs (CCEA), chaired by the Prime Minister Shri Narendra Modi, to approve two significant foreign investments (FIs) in the pharmaceutical sector - Aurobindo Pharma Ltd; and Glenmark Pharmaceutical Ltd. Speaking to The Dollar Business, Dr P V Appaji, Director General, Pharmexcil said, “The recent move by the Government augurs well for the domestic pharmaceutical companies as they can now augment funds from foreign investors to focus on the export market. Moreover, with the new development, the confidence of the Indian pharma manufacturers will be on a high as these investments show the continued confidence of international ...
