Granules India gets USFDA approval for Butalbital, Acetaminophen, Caffeine capsules
Granules India Ltd on Thursday said its foreign subsidiary has received approval from the US health regulator for Butalbital, Acetaminophen and Caffeine Capsules used to treat tension headaches.
In a regulatory filing the company said "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 Ltd for Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg."
Disclaimer: No Business Standard Journalist was involved in creation of this content