Granules Pharmaceuticals, Inc gets USFDA nod for Colchicine tablets

Granules India on Thursday said its wholly owned foreign arm has received US health regulator's approval for Colchicine tablets, used in the treatment of familial mediterranean fever. Familial mediterranean fever is a genetic disorder that causes recurrent episodes of fever that are typically accompanied by pain in the abdomen, chest, or joints. "The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc, a wholly owned foreign subsidiary of Granules India Ltd for Colchicine tablets USP, 0.6 mg," the company said in a regulatory filing. The filing further said that "it is bioequivalent to the reference listed drug product (RLD), Colcrys tablets, 0.6 mg, of Takeda Pharmaceuticals USA, Inc." Shares of Granules India were trading at Rs 159.55 a piece on BSE, up 3.74 per cent from the previous close. SID DRR

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!