01 1Sanbo Chemical Laboratory Co., Ltd.
02 1Sicor de Me(´)xico,S. A. de C. V.
01 1Fluorouracil "Teva 2"
02 1Japanese Pharmacopoeia fluorouracil (production only)
01 1Japan
02 1Mexico
Japanese Pharmacopoeia Fluorouracil (for manufacturing only)
Registration Number : 218MF10560
Registrant's Address : 1-31 Kannanbecho, Sakai-ku, Sakai-shi, Osaka
Initial Date of Registration : 2006-06-02
Latest Date of Registration : 2006-09-22
Registration Number : 227MF10172
Registrant's Address : Av. San Rafael No. 35 Parque Industrial Lerma, CP52000 Lerma, Edo. Me(´)xico. MEXICO
Initial Date of Registration : 2015-06-26
Latest Date of Registration : 2015-06-26
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PharmaCompass also assists you with knowing the Fluorouracil API Price utilized in the formulation of products. Fluorouracil API Price is not always fixed or binding as the Fluorouracil Price is obtained through a variety of data sources. The Fluorouracil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A CAS-51-21-8 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-51-21-8, including repackagers and relabelers. The FDA regulates CAS-51-21-8 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-51-21-8 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-51-21-8 supplier is an individual or a company that provides CAS-51-21-8 active pharmaceutical ingredient (API) or CAS-51-21-8 finished formulations upon request. The CAS-51-21-8 suppliers may include CAS-51-21-8 API manufacturers, exporters, distributors and traders.
click here to find a list of CAS-51-21-8 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 CAS-51-21-8 Drug Master File in Japan (CAS-51-21-8 JDMF) empowers CAS-51-21-8 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-51-21-8 JDMF during the approval evaluation for pharmaceutical products. At the time of CAS-51-21-8 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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