News | February 20, 2023
Dalton ramp ups sterile manufacturing capacity
The new sterile filling line meets cGMP aseptic filling regulatory requirements
The new sterile filling line meets cGMP aseptic filling regulatory requirements
Fluor is providing architectural and engineering services and procuring equipment for the new 275,000 square-foot manufacturing facility that will house two manufacturing lines to double manufacturing capability
Yonghe as the CDMO partner will provide production process development and cGMP manufacturing services for Ablaze
A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940
The investment will enable the company to enter European markets as well as enhance margins in current markets
GMP-compliant documentation of all manufacturing steps for cell and gene therapies
Expanded capacity in Nansha, China will support mid-scale manufacturing to ensure a smooth transition between early-phase and large-scale commercial production
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 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
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
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