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Granules India Limited Receives Approval From US FDA For Colchicine Tablets

Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India Limited for Colchicine Tablets USP, 0.6 mg. It is bioequivalent to the reference listed drug product (RLD), Colcrys Tablets, 0.6 mg, of Takeda Pharmaceuticals USA, Inc. This marks the second Paragraph IV ANDA approval for Granules.

Colcrys® is a trademark of Takeda Pharmaceuticals USA, Inc. Colchicine Tablets are used for the treatment of Familial Mediterranean Fever (FMF).

The Colcrys® brand and generic had U.S. sales of approximately $492 million MAT for the most recent twelve months ending in December 2019 according to lIQVIA Health.

“With back to back two Paragraph IV ANDA approvals in this week; we received total 8 approvals for ANDAs filed by GPI. This demonstrates the capability of GPI, confirming our investment strategy in this facility” said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc., commenting on the approval.

Shares of GRANULES INDIA LTD. was last trading in BSE at Rs.153.8 as compared to the previous close of Rs. 145.95. The total number of shares traded during the day was 99499 in over 1976 trades.

The stock hit an intraday high of Rs. 154.5 and intraday low of 147.2. The net turnover during the day was Rs. 15154145.-Equity Bulls

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