Common use of Drug Master File Clause in Contracts

Drug Master File. RTU shall produce and maintain a drug master file for Drug Substance made under this Agreement, which shall contain all information necessary to comply with the regulatory authority, and all European Pharmacopoeia standards with respect to the applicable manufacturing processes and Drug Product.

Drug Master File. RTU shall produce and maintain a drug master file for Drug Substance made under this Agreement, which shall contain all information necessary to comply with the regulatory authorityapplicable Regulatory Authority, and all European U.S. Pharmacopoeia standards with respect to the applicable manufacturing processes and Drug Product.

Drug Master File. RTU shall produce and maintain a drug master file for Drug Substance made under this Agreement, which shall contain all information necessary to comply with the regulatory authority, and all European Pharmacopoeia MHLW standards with respect to the applicable manufacturing processes and Drug Product.

Drug Master File. RTU shall produce and maintain a drug master file for Drug Substance made under this Agreement, which shall contain all information necessary to comply with the regulatory authorityFDA, U.S. Environmental Protection Agency, and all European U.S. Pharmacopoeia standards standards, and, with respect to countries in the Territory other than the United States, their non-U.S. equivalents, with respect to the applicable manufacturing processes and Drug Product.