The pharma company has received the final approval for Lansoprazole tablets (15 mg & 30 mg) and a tentative approval for Linagliptin tablets (5 mg).
Cadila Healthcare has received the final USFDA approval for Lansoprazole tablets (15 mg & 30 mg) and a tentative approval for Linagliptin tablets (5 mg).
The pharma company has “received the final approval from the USFDA to market Lansoprazole delayed-release, orally disintegrating tablets (US RLD- Prevacid), 15 mg and 30 mg”, Cadila Healthcare said in a release to the BSE. It will be manufactured at the groups formulations manufacturing facility at Moraiya, Ahmedabad, the company added.
Lansoprazole is in a class of drugs called proton pump inhibitors (PPI) which block the production of acid by the stomach. Proton pump inhibitors are used for the treatment of conditions such as ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome that are caused by stomach acid.
Meanwhile, it has also received a tentative approval for Linagliptin tablets (US RLD- Tradjenta), 5 mg. Linagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus and will be manufactured at the groups formulations manufacturing facility at SEZ, Ahmedabad.
The group now has 236 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY2003-04.
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