New manufacturing facility dedicated to the production of active pharmaceutical ingredients (APIs) and high potency active pharmaceutical ingredients (HPAPIs)
USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
ADCelerate delivers Phase I appropriate antibody-drug conjugate (ADC) drug substance and drug product for Investigational New Drug (IND) submission
Plant is part of the company's CAD $30 million capital investment in the site
The appointments will add to the well-diversified experience that currently exists on the PPL board.
Brings 25 years of global operations and supply chain experience to Piramal
Site has a capital investment program of ~$30 million spent or committed over the last three years to expand capabilities and improve operational efficiencies
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