The Cebu Provincial Government has signed a memorandum of agreement with the Department of Science and Technology and the Food and Drugs Administration to improve the quality of products produced by ...
The GMP inspection, conducted by EMA representatives from April 8-12, assessed mammalian and microbial drug substance ...
The company has has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and ...
The GMP inspection, conducted by EMA representatives from April 8-12, 2024, assessed mammalian and microbial drug substance ...
ADC Drug Substance and Drug Product process development and cGMP manufacturing. Waterstone will supply Linker-payload, a ...
The U.S. Food and Drug Administration (FDA) has announced that the recall was voluntarily initiated by the company, as a result of "CGMP [Current Good Manufacturing Practice] Deviations: Presence of N ...
The additional recruitments will help the Drugs Controller General of India enforce good manufacturing practices for ...
Pharma player Granules India Limited on Friday said it has received an Establishment Inspection Report (EIR) from the US Food ...
The Company's BLA for pz-cel was previously accepted for Priority Review by the FDA for patients with RDEB. Abeona may be ...
The U.S. Food and Drug Administration has lifted a clinical hold on three cell therapies being developed by CARsgen ...