01 1Lundbeck Pharmaceuticals Italy S. p. A
02 2Mitsubishi Tanabe Pharma Factory, Ltd.
03 1Tianjin Weijie Pharmaceutical Co. , Ltd.
01 4Argatroban hydrate
01 1China
02 1Denmark
03 2Japan
Registration Number : 227MF10090
Registrant's Address : Via Quarta Strada, 2 Padova, Italy
Initial Date of Registration : 2015-03-12
Latest Date of Registration : 2015-03-12
Registration Number : 228MF10013
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 3-2-10
Initial Date of Registration : 2016-01-08
Latest Date of Registration : 2016-01-08
Registration Number : 222MF10221
Registrant's Address : 3-16-89 Kashima, Yodogawa-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2010-08-23
Latest Date of Registration : 2017-02-08
Registration Number : 230MF10006
Registrant's Address : 28 Qixia Street Hangu Morden Industrial Park, TEDA, Tianjin China
Initial Date of Registration : 2018-01-10
Latest Date of Registration : 2018-01-10
A Argatroban Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Argatroban Monohydrate, including repackagers and relabelers. The FDA regulates Argatroban Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Argatroban Monohydrate 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 Argatroban Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Argatroban Monohydrate supplier is an individual or a company that provides Argatroban Monohydrate active pharmaceutical ingredient (API) or Argatroban Monohydrate finished formulations upon request. The Argatroban Monohydrate suppliers may include Argatroban Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Argatroban Monohydrate 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 Argatroban Monohydrate Drug Master File in Japan (Argatroban Monohydrate JDMF) empowers Argatroban Monohydrate 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 Argatroban Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Argatroban Monohydrate 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 Argatroban Monohydrate suppliers with JDMF on PharmaCompass.
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