01 1Osaka Synthetic Organic Chemistry Laboratory Co., Ltd.
02 1Sanyo Chemical Research Institute Co., Ltd.
03 1Sanyo Fine Co., Ltd.
01 1Japanese Pharmacopoeia "tartaric acid protirelin"
02 1Japanese Pharmacopoeia tartaric acid ifenprodil (production only)
03 1Japanese Pharmacopoeia tartaric acid ifenprodil production dedicated
01 2Gabon
02 1Japan
Japanese Pharmacopoeia Ifenprodil Tartrate For manufacturing only
Registration Number : 217MF10397
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2005-08-10
Latest Date of Registration : 2006-07-03
Japanese Pharmacopoeia "Protirelin Tartrate"
Registration Number : 217MF10190
Registrant's Address : Osaka Prefecture, Osaka City, Nishi Ward, Awaza 1-12-18
Initial Date of Registration : 2005-07-01
Latest Date of Registration : 2008-08-28
Japanese Pharmacopoeia Ifenprodil Tartrate (for manufacturing only)
Registration Number : 217MF10164
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2005-05-31
Latest Date of Registration : 2024-02-29
A DL-Tartaric acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DL-Tartaric acid, including repackagers and relabelers. The FDA regulates DL-Tartaric acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DL-Tartaric acid 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 DL-Tartaric acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DL-Tartaric acid supplier is an individual or a company that provides DL-Tartaric acid active pharmaceutical ingredient (API) or DL-Tartaric acid finished formulations upon request. The DL-Tartaric acid suppliers may include DL-Tartaric acid API manufacturers, exporters, distributors and traders.
click here to find a list of DL-Tartaric acid 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 DL-Tartaric acid Drug Master File in Japan (DL-Tartaric acid JDMF) empowers DL-Tartaric acid 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 DL-Tartaric acid JDMF during the approval evaluation for pharmaceutical products. At the time of DL-Tartaric acid 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 DL-Tartaric acid suppliers with JDMF on PharmaCompass.
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