USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva
The company has received Form 483 with three observations
The company has received Form 483 with three observations
Biologics manufacturing to expand the Aragen platform by offering “gene to GMP” solution
Lupin enters into BTA with Lupin Manufacturing Solutions
The new gummy capabilities include a dedicated R&D lab, an automated production line, and bottle packaging solutions
Increased capability to produce medicines for challenging diseases including cancer
The extension builds upon an existing long-term collaboration for end-to-end ADC manufacturing, including payload, monoclonal antibody (mAb) manufacturing and bioconjugation
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The investment will help the company meet soaring demand for user-friendly oral dosage form development and manufacturing
InvaGen has received 5 inspectional observations in Form 483
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