01 1Chungking Carelife Pharmaceutical Co., Ltd.
01 1Mitoxantrone Hydrochloride
01 1China
Registration Number : 302MF10131
Registrant's Address : 3 Hua Nanyi Road Chongqing (Changshou) Chemical Industrial Park Chongqing 401254
Initial Date of Registration : 2020-10-26
Latest Date of Registration : 2020-10-26
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A BRD-K21680192-300-12-8 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BRD-K21680192-300-12-8, including repackagers and relabelers. The FDA regulates BRD-K21680192-300-12-8 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BRD-K21680192-300-12-8 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 BRD-K21680192-300-12-8 supplier is an individual or a company that provides BRD-K21680192-300-12-8 active pharmaceutical ingredient (API) or BRD-K21680192-300-12-8 finished formulations upon request. The BRD-K21680192-300-12-8 suppliers may include BRD-K21680192-300-12-8 API manufacturers, exporters, distributors and traders.
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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 BRD-K21680192-300-12-8 Drug Master File in Japan (BRD-K21680192-300-12-8 JDMF) empowers BRD-K21680192-300-12-8 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 BRD-K21680192-300-12-8 JDMF during the approval evaluation for pharmaceutical products. At the time of BRD-K21680192-300-12-8 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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