01 2Fujian Fukang Pharmaceutical Co. , Ltd.
02 1Lek Pharmaceuticals d. d.
01 1Gentamicin Sulfate
02 1Gentamicin sulfate
03 1Gentamicin sulfate (production only)
01 2China
02 1Slovenia
Registration Number : 220MF10170
Registrant's Address : No. 6, Gaogang Avenue, Jiangyin Industrial Estate, Fuqing, Fuzhou, Fujian, China
Initial Date of Registration : 2008-07-24
Latest Date of Registration : 2011-10-21
Gentamicin sulfate (for manufacturing purposes only)
Registration Number : 217MF10342
Registrant's Address : No. 6, Gaogang Avenue, Jiangyin Industrial Estate, Fuqing, Fuzhou, Fujian, China
Initial Date of Registration : 2005-07-27
Latest Date of Registration : 2012-08-13
Registration Number : 220MF10041
Registrant's Address : Verovskova ulica 57, 1526 Ljubljana, Slovenia
Initial Date of Registration : 2008-02-05
Latest Date of Registration : 2017-06-15
A Gentamicin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gentamicin, including repackagers and relabelers. The FDA regulates Gentamicin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gentamicin 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 Gentamicin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gentamicin supplier is an individual or a company that provides Gentamicin active pharmaceutical ingredient (API) or Gentamicin finished formulations upon request. The Gentamicin suppliers may include Gentamicin API manufacturers, exporters, distributors and traders.
click here to find a list of Gentamicin 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 Gentamicin Drug Master File in Japan (Gentamicin JDMF) empowers Gentamicin 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 Gentamicin JDMF during the approval evaluation for pharmaceutical products. At the time of Gentamicin 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 Gentamicin suppliers with JDMF on PharmaCompass.
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