01 1Qingdao Taidong Pharmaceutical Co., Ltd.
02 1Sekisui Medical Co., Ltd.
01 1DL- methionine
02 1γ - amino butyric acid
01 1China
02 1Japan
Registration Number : 219MF10244
Registrant's Address : No. 22, Huahai Road, Chengyang District, Qingdao City (Huanhai Economic Development Z...
Initial Date of Registration : 2007-07-17
Latest Date of Registration : 2007-07-17
Registration Number : 217MF10771
Registrant's Address : 3-13-5 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-20
Latest Date of Registration : 2010-02-25
A Methionine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methionine, including repackagers and relabelers. The FDA regulates Methionine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methionine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Methionine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methionine supplier is an individual or a company that provides Methionine active pharmaceutical ingredient (API) or Methionine finished formulations upon request. The Methionine suppliers may include Methionine API manufacturers, exporters, distributors and traders.
click here to find a list of Methionine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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 Methionine Drug Master File in Japan (Methionine JDMF) empowers Methionine 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 Methionine JDMF during the approval evaluation for pharmaceutical products. At the time of Methionine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Methionine suppliers with JDMF on PharmaCompass.
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