01 2Katsura Chemical Co., Ltd.
01 1Atropine Sulfate Hydrate-K
02 1Atropine sulfate hydrate
01 2Japan
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
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
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PharmaCompass offers a list of Atropine Sulfate 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 Atropine Sulfate manufacturer or Atropine Sulfate supplier for your needs.
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PharmaCompass also assists you with knowing the Atropine Sulfate API Price utilized in the formulation of products. Atropine Sulfate API Price is not always fixed or binding as the Atropine Sulfate Price is obtained through a variety of data sources. The Atropine Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A LOMOTIL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LOMOTIL, including repackagers and relabelers. The FDA regulates LOMOTIL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LOMOTIL 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 LOMOTIL supplier is an individual or a company that provides LOMOTIL active pharmaceutical ingredient (API) or LOMOTIL finished formulations upon request. The LOMOTIL suppliers may include LOMOTIL API manufacturers, exporters, distributors and traders.
click here to find a list of LOMOTIL 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 LOMOTIL Drug Master File in Japan (LOMOTIL JDMF) empowers LOMOTIL 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 LOMOTIL JDMF during the approval evaluation for pharmaceutical products. At the time of LOMOTIL 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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