01 2Ajinomoto Co., Inc.
02 1DIVI'S LABORATORIES LIMITED
03 1Shandong Xinhua Pharmaceutical Co. , Ltd.
01 2Japanese Pharmacopoeia levodopa (production only)
02 1L-Dihydroxyphenylalanine
03 1Levodopa
01 1China
02 1India
03 2Japan
Registration Number : 302MF10140
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2020-11-26
Latest Date of Registration : 2020-11-26
Japanese Pharmacopoeia Levodopa (for manufacturing only)
Registration Number : 221MF10284
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2009-12-22
Latest Date of Registration : 2009-12-22
Registration Number : 227MF10235
Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers, Cyber Hills, Gachibowli, Hyderabad-500 032, ...
Initial Date of Registration : 2015-09-24
Latest Date of Registration : 2018-04-12
Japanese Pharmacopoeia Levodopa (for manufacturing only)
Registration Number : 221MF10029
Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China
Initial Date of Registration : 2009-02-09
Latest Date of Registration : 2009-02-09
A CAS-59-92-7 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-59-92-7, including repackagers and relabelers. The FDA regulates CAS-59-92-7 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-59-92-7 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 CAS-59-92-7 supplier is an individual or a company that provides CAS-59-92-7 active pharmaceutical ingredient (API) or CAS-59-92-7 finished formulations upon request. The CAS-59-92-7 suppliers may include CAS-59-92-7 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 CAS-59-92-7 Drug Master File in Japan (CAS-59-92-7 JDMF) empowers CAS-59-92-7 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 CAS-59-92-7 JDMF during the approval evaluation for pharmaceutical products. At the time of CAS-59-92-7 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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