The National Institute of Pharmacy and Nutrition, Hungary has issued 'Certificate of GMP Compliance of Manufacturer' for IOL Chemicals and Pharmaceuticals Limited's products.
GMP-compliant documentation of all manufacturing steps for cell and gene therapies
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days
WuXi STA’s drug product site in Wuxi City offers a full range of services including formulation development and manufacturing for a broad range of oral and injectable dosage forms
The company will engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.
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