Zydus Cadila gets US FDA nod to market tablets for diabetic care

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the Indian Bourses on Tuesday, Dr Pankaj Patel led Zydus Cadila group (Cadila Healthcare Ltd.) said of having got approval from US FDA (Food & Drugs Administration) to market Sitagliptin Tablets in dosage value of 25 mg (milligram), 50 mg and 100 mg.

Zydus Cadila has received the tentative approval from the USFDA for Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg (US RLD —Januvia® Tablets), the company release read.

It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.

Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally).

Sitagliptin is in a class of medications called dipeptidyl peptidase—4 (DPP-4) inhibitors.

It works by increasing the amounts of certain natural substances that lower blood sugar when it is high.

The group now has 217 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY2003-04.

Immediately after the press release hit the exchange, investors & traders reacted positively to the news and positive impact was felt on the share price of the company with an instant spike, but soon the shares continued to trade on choppy session ending on negative counters in RED Zone, on Tuesday, when the trading session on the Indian Bourses ended.


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