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.
According to IQVIA sales data for the 12-month period ending September 2022, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately US $1.8 billion
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
Results reinforce commitment to next-generation oral SERD development programme
Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib
Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 112 million in the U.S. (IQVIA MAT August 2022).
A well researched and affordable fixed dose combination, which will significantly improve the glycemic control in adult patients suffering from uncontrolled Type 2 diabetes, especially the ones with comorbidities
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