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.
Innovative Capsugel Enprotect capsule can simplify the manufacturing process to accelerate drug development and expedite first-in-human timelines
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.
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
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
Pluvicto and Scemblix launches are progressing well and we are awaiting data in earlier lines of therapy.
Around 62% of the revenues came from the domestic market and 38% from the exports market for Q2 FY23 for a standalone business
The award recognizes Parexel for delivering the best decentralized trial experience for customers through its capabilities, expertise, and patient recruitment and retention strategies
The TBDA is a collaboration established among biopharmaceutical companies, research organizations and universities to accelerate the discovery and development of novel therapeutic candidates against TB.
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