This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units
The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
The company will reduce wastage substantially, increase productivity, enhance environmental consciousness, save energy, optimally use natural resources, and expand its market penetration
Revenue is up 23% whereas Profit After Tax expands 29% for the company
NFIL’s ambition is to reach revenues of US$100mn from CDMO by FY25.
The new plant will include a wide range of dosage form capabilities for oral solids, liquids, topicals, films, and manufacturing technologies for granulation, film coating, spray drying, tableting
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
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