01 1Sumitomo Chemical Co., Ltd.
02 1Syn-Tech Chem. & Pharm. Co. , Ltd.
01 1Crotamiton
02 1Japan Pharmaceutical Codex crotamiton
01 1Japan
02 1Taiwan
Japanese Pharmacopoeia Non-Drug Standards Crotamiton
Registration Number : 217MF10075
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-23
Latest Date of Registration : 2021-12-09
Registration Number : 228MF10116
Registrant's Address : No. 168 Kai-Yuan Rd. , Hsin-Ying Tainan City, 73055. Taiwan
Initial Date of Registration : 2016-06-21
Latest Date of Registration : 2016-06-21
A Crotamiton manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Crotamiton, including repackagers and relabelers. The FDA regulates Crotamiton manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Crotamiton 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 Crotamiton manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Crotamiton supplier is an individual or a company that provides Crotamiton active pharmaceutical ingredient (API) or Crotamiton finished formulations upon request. The Crotamiton suppliers may include Crotamiton API manufacturers, exporters, distributors and traders.
click here to find a list of Crotamiton 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 Crotamiton Drug Master File in Japan (Crotamiton JDMF) empowers Crotamiton 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 Crotamiton JDMF during the approval evaluation for pharmaceutical products. At the time of Crotamiton 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 Crotamiton suppliers with JDMF on PharmaCompass.
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