01 2Katsura Chemical Co., Ltd.
01 1Atropine Sulfate Hydrate-K
02 1Atropine sulfate hydrate
01 2Japan
Registration Number : 303MF10180
Registrant's Address : 4-15-19 Hibarigaoka, Zama City, Kanagawa Prefecture
Initial Date of Registration : 2021-12-15
Latest Date of Registration : 2021-12-15
Registration Number : 221MF10005
Registrant's Address : 4-15-19 Hibarigaoka, Zama City, Kanagawa Prefecture
Initial Date of Registration : 2009-01-13
Latest Date of Registration : 2009-01-13
A Atropine Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atropine Sulfate, including repackagers and relabelers. The FDA regulates Atropine Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atropine Sulfate 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 Atropine Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Atropine Sulfate supplier is an individual or a company that provides Atropine Sulfate active pharmaceutical ingredient (API) or Atropine Sulfate finished formulations upon request. The Atropine Sulfate suppliers may include Atropine Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Atropine Sulfate 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 Atropine Sulfate Drug Master File in Japan (Atropine Sulfate JDMF) empowers Atropine Sulfate 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 Atropine Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Atropine Sulfate 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 Atropine Sulfate suppliers with JDMF on PharmaCompass.
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