Drug Approval | November 03, 2022
Glenmark receives ANDA approval for Sodium Phenylbutyrate Tablets
Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.
Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.
The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
The expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 112 million in the U.S. (IQVIA MAT August 2022).
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of US $112 million in the US
Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data
The need for hot-melt extrusion (HME) polymers is expected to grow as the pharma industry moves to implement more continuous and sustainable processes.
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
The product will be manufactured at Lupin's facility in Nagpur, India.
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