01 1AMINO GmbH
02 2Ajinomoto Health & Nutrition North America, Inc.
03 1Kyowa Hakko Bio Co., Ltd.
01 3Japanese Pharmacopoeia L- tryptophan (production only)
02 1L-tryptophan
01 1Germany
02 3Japan
Japanese Pharmacopoeia L-Tryptophan (for manufacturing purposes only)
Registration Number : 227MF10115
Registrant's Address : 4020 Ajinomoto Drive Raleigh, North Carolina 27610, USA
Initial Date of Registration : 2015-04-21
Latest Date of Registration : 2015-04-21
Japanese Pharmacopoeia L-Tryptophan (for manufacturing purposes only)
Registration Number : 220MF10074
Registrant's Address : 4020 Ajinomoto Drive Raleigh, North Carolina 27610, USA
Initial Date of Registration : 2008-03-14
Latest Date of Registration : 2008-03-14
Registration Number : 306MF10053
Registrant's Address : An der Zucker-Raffinerie 9, 38373 Frellstedt, Germany
Initial Date of Registration : 2024-04-10
Latest Date of Registration : 2024-04-10
Japanese Pharmacopoeia L-Tryptophan (for manufacturing purposes only)
Registration Number : 217MF10228
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-06-15
Latest Date of Registration : 2006-11-15
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A Tox21_300359 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tox21_300359, including repackagers and relabelers. The FDA regulates Tox21_300359 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tox21_300359 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Tox21_300359 supplier is an individual or a company that provides Tox21_300359 active pharmaceutical ingredient (API) or Tox21_300359 finished formulations upon request. The Tox21_300359 suppliers may include Tox21_300359 API manufacturers, exporters, distributors and traders.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Tox21_300359 Drug Master File in Japan (Tox21_300359 JDMF) empowers Tox21_300359 API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Tox21_300359 JDMF during the approval evaluation for pharmaceutical products. At the time of Tox21_300359 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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