01 1Nippon Protein Co., Ltd.
02 1Nippon Rika Pharmaceuticals Co., Ltd.
03 2Taenaka Mining Co., Ltd.
01 1Japanese Pharmacopoeia L- cysteine
02 1Japanese Pharmacopoeia L- cystine (production only)
03 2Outsiders regulations L- cystine (production only)
01 4Japan
Japanese Pharmacopoeia L-cysteine
Registration Number : 219MF10338
Registrant's Address : 2-2 Nihonbashi Honcho 4-chome, Chuo-ku, Tokyo
Initial Date of Registration : 2007-11-21
Latest Date of Registration : 2007-11-21
Non-regulated L-cystine (for manufacturing purposes only)
Registration Number : 218MF11012
Registrant's Address : 575-1 Shimada-cho, Ashikaga City, Tochigi Prefecture
Initial Date of Registration : 2006-12-18
Latest Date of Registration : 2006-12-18
Non-regulated L-cystine (for manufacturing purposes only)
Registration Number : 217MF10284
Registrant's Address : 452 Oshiba, Mobara City, Chiba Prefecture
Initial Date of Registration : 2005-06-20
Latest Date of Registration : 2007-07-26
Japanese Pharmacopoeia L-Cystine (for manufacturing purposes only)
Registration Number : 225MF10115
Registrant's Address : 452 Oshiba, Mobara City, Chiba Prefecture
Initial Date of Registration : 2013-06-07
Latest Date of Registration : 2013-06-07
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PharmaCompass offers a list of Cystine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cystine manufacturer or Cystine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cystine manufacturer or Cystine supplier.
PharmaCompass also assists you with knowing the Cystine API Price utilized in the formulation of products. Cystine API Price is not always fixed or binding as the Cystine Price is obtained through a variety of data sources. The Cystine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cystine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cystine, including repackagers and relabelers. The FDA regulates Cystine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cystine 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 Cystine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cystine supplier is an individual or a company that provides Cystine active pharmaceutical ingredient (API) or Cystine finished formulations upon request. The Cystine suppliers may include Cystine API manufacturers, exporters, distributors and traders.
click here to find a list of Cystine 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 Cystine Drug Master File in Japan (Cystine JDMF) empowers Cystine 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 Cystine JDMF during the approval evaluation for pharmaceutical products. At the time of Cystine 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 Cystine suppliers with JDMF on PharmaCompass.
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