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
Through the collaboration, Lonza will gain access to Singzyme’s enzymatic conjugation platform enabling the site-specific binding of payloads with peptidic linkers to proteins of interest
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 participants discussed the latest developments under ABDM that shall enable true interoperability in the health sector and how effective adoption of ABDM can pave the way towards Universal Health Coverage
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.
NFIL’s ambition is to reach revenues of US$100mn from CDMO by FY25.
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
The observation is procedural in nature and the company will address the observation within stipulated timelines.
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