definiens: means current Good Manufacturing Practice as promulgated by the FDA under and in accordancewith the U.S. Federal Food, Drug and Cosmetic Act ( Title 21 of the U.S. Code, Section 301 et seq . ), Title 21, Parts210 and 211 of the U.S. Code of Federal Regulations, and the guidelines and standards published by the FDA thatrelate to the testing, manufacturing, processing, packaging, holding or distribution of drug substances and finisheddrugs . also includes the practices and standards described in the Guide to Good Manufacturing Practices forMedicinal Products as promulgated by the European Commission under European Directive 2003/94 / EC, similarstandards, guidelines and regulations * * * INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WASREQUESTED . ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES ANDEXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933,AS AMENDED