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 laboratory is equipped to perform high-volume diagnostic testing services
Innovative Capsugel Enprotect capsule can simplify the manufacturing process to accelerate drug development and expedite first-in-human timelines
API platform to comprise of RA Chem Pharma, ZCL Chemicals and Avra Laboratories
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
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.
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
NFIL’s ambition is to reach revenues of US$100mn from CDMO by FY25.
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