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 MHLW standards with respect to the applicable manufacturing processes and Drug Product.
Appears in 1 contract
Samples: Lubiprostone Exclusive Manufacturing and Supply Agreement (Sucampo Pharmaceuticals, Inc.)
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 MHLW the regulatory authority, and all European Pharmacopoeia standards with respect to the applicable manufacturing processes and Drug Product. Article 7.6.
Appears in 1 contract
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 MHLW standards FDA, U.S. Environmental Protection Agency, and all U.S. Pharmacopoeia 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.
Appears in 1 contract
Samples: Manufacturing and Supply Agreement (Sucampo Pharmaceuticals, Inc.)
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 MHLW the regulatory authority, and all European Pharmacopoeia standards with respect to the applicable manufacturing processes and Drug Product.
Appears in 1 contract
Samples: 0211 Exclusive Manufacturing and Supply Agreement (Sucampo Pharmaceuticals, Inc.)
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 MHLW the applicable Regulatory Authority, and all U.S. Pharmacopoeia standards with respect to the applicable manufacturing processes and Drug Product.
Appears in 1 contract
Samples: Lubiprostone Exclusive Manufacturing and Supply Agreement (Sucampo Pharmaceuticals, Inc.)
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 MHLW the applicable Regulatory Authority, and all U.S. Pharmacopoeia standards with respect to the applicable manufacturing processes and Drug Product. Article 7.6.
Appears in 1 contract
Samples: Supply Agreement
