The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
The facility is a part of Lupin Manufacturing Solutions
Acquisition provides Ligand with the royalty rights to QARZIBA, a highly differentiated, commercial oncology drug marketed in 35 countries by global pharmaceutical company Recordati S.p.A.
This existing GMP compliant facility, located at Bharuch (Unit-1) with ongoing expansion part of the company's strategic capex initiative
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