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 ...
and report compounded drugs to the FDA. The facilities must also comply with Current Good Manufacturing Practices ...
The company has has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and ...
The Company's BLA for pz-cel was previously accepted for Priority Review by the FDA for patients with RDEB. Abeona may be ...