The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.
Quality / GMP | 18/10/2023 | By Manvi | 170
Gritgen Therapeutics Launches Operations at Commercial GMP Facility in China
The facility adheres to the global cGMP standards and complies with the regulatory guidelines of authoritative agencies including the NMPA, the FDA and the EMA.
Quality / GMP | 16/10/2023 | By Manvi | 133
Aurisco's Manufacturing Site in China Clears FDA Inspection
Aurisco's Manufacturing Site in China Clears FDA Inspection
Quality / GMP | 24/08/2023 | By Sudeep Soparkar | 146
Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets (OTC)
Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets (OTC)
Quality / GMP | 23/08/2023 | By Sudeep Soparkar | 139
Quality / GMP | 23/08/2023 | By Sudeep Soparkar | 152
Successful FDA inspection at Auriscos manufacturing site in Yangzhou, China
Successful FDA inspection at Aurisco's manufacturing site in Yangzhou, China
Quality / GMP | 16/08/2023 | By Sudeep Soparkar | 211
Lupins Mandideep Unit-2 Facility Completes U.S. FDA Inspection with No Observations
Lupin’s Mandideep Unit-2 Facility Completes U.S. FDA Inspection with No Observations
Quality / GMP | 14/08/2023 | By Sudeep Soparkar | 147
Dr. Reddys API plant in Hyderabad gets EIR from U.S. FDA
Dr. Reddy’s API plant in Hyderabad gets EIR from U.S. FDA
Quality / GMP | 08/08/2023 | By Sudeep Soparkar | 337
Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis
Quality / GMP | 08/08/2023 | By Sudeep Soparkar | 217
USFDA concludes inspection at Solara's Cuddalore facility with Zero 483 inspectional observations
USFDA concludes inspection at Solara's Cuddalore facility with Zero 483 inspectional observations
Quality / GMP | 08/08/2023 | By Sudeep Soparkar
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