The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The inspection concluded with the issuance of a form 483 with five observations
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
Reported profit after tax declined 19% year-on-year to Rs 76 crores
Lonza plans to invest approximately CHF 500 million to upgrade the facility
For 9 months period ended December 2023, the company’s PAT up 16% to Rs 330 crores (before exceptional items)
Biologics manufacturing to expand the Aragen platform by offering “gene to GMP” solution
Profit after tax (before exceptional items) up 23% to Rs 215 crores
The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally
Increased capability to produce medicines for challenging diseases including cancer
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