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01 1Fermion Oy
02 1CHONGQING KANGLE PHARMACEUTICAL CO. , LTD.
01 2Hydroxychloroquine Sulfate
01 1China
02 1Finland
Registration Number : 305MF10090
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2023-08-02
Latest Date of Registration : 2023-08-02
Registration Number : 305MF10077
Registrant's Address : No. 4 HUAZHONG ROAD, CHONGQING (CHANGSHOU) CHEMICAL INDUSTRIAL PARK
Initial Date of Registration : 2023-07-05
Latest Date of Registration : 2023-07-05
A Plaquenil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Plaquenil, including repackagers and relabelers. The FDA regulates Plaquenil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Plaquenil 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 Plaquenil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Plaquenil supplier is an individual or a company that provides Plaquenil active pharmaceutical ingredient (API) or Plaquenil finished formulations upon request. The Plaquenil suppliers may include Plaquenil API manufacturers, exporters, distributors and traders.
click here to find a list of Plaquenil 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 Plaquenil Drug Master File in Japan (Plaquenil JDMF) empowers Plaquenil 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 Plaquenil JDMF during the approval evaluation for pharmaceutical products. At the time of Plaquenil 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 Plaquenil suppliers with JDMF on PharmaCompass.
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