01 1ACS DOBFAR S. p. A.
02 1Shandong Anxin Pharmaceutical Co. , Ltd.
01 1Amikacin Sulfate
02 1Day stations amikacin sulfate "production-only"
01 1China
02 1Italy
Registration Number : 301MF10052
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2019-08-28
Latest Date of Registration : 2022-05-25
JP Amikacin Sulfate (For manufacturing purposes only)
Registration Number : 222MF10057
Registrant's Address : No. 10678 Wenliang Road, Dongjia Town, Licheng District, Jinan, Shandong Province, P....
Initial Date of Registration : 2010-02-16
Latest Date of Registration : 2010-02-16
A Amikacin Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amikacin Sulfate, including repackagers and relabelers. The FDA regulates Amikacin Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amikacin 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 Amikacin Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amikacin Sulfate supplier is an individual or a company that provides Amikacin Sulfate active pharmaceutical ingredient (API) or Amikacin Sulfate finished formulations upon request. The Amikacin Sulfate suppliers may include Amikacin Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Amikacin 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 Amikacin Sulfate Drug Master File in Japan (Amikacin Sulfate JDMF) empowers Amikacin 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 Amikacin Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Amikacin 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 Amikacin Sulfate suppliers with JDMF on PharmaCompass.
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