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.
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
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
Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data
The observation is procedural in nature and the company will address the observation within stipulated timelines.
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
The CRL did not identify any outstanding scientific issues with the product.
Oncodesign Services (ODS ), with 600 clients in 33 countries and 227 employees worldwide, provides services from target identification to hit-to-lead and lead optimization through to IND filing.
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