The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
The maker of ivermectin/pyrantel, the #1 vet-recommended and #1 dog-preferred real beef chew introduces the latest innovation in its portfolio
This four-day course is designed for professionals in the pharmaceutical, nutraceutical, and related industries
The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands
The company will submit its comprehensive response on these observations to the USFDA
The company will supply materials to all global regions including Asia such as China, India, Europe, and the U.S.
Sajjan India Limited is looking for expansion, both organically and through acquisitions, to achieve the planned growth
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
The company will submit its comprehensive response on these observations to the US FDA
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