01 3FORMOSA LABORATORIES, INC.
02 1Glenmark Life Sciences Limited
03 1JUBILANT PHARMOVA LIMITED
01 1For linezolid oral
02 4Linezolid
01 2India
02 3Taiwan
Registration Number : 226MF10166
Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
Initial Date of Registration : 2014-09-01
Latest Date of Registration : 2014-11-17
Registration Number : 225MF10170
Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
Initial Date of Registration : 2013-08-28
Latest Date of Registration : 2014-11-17
Registration Number : 302MF10099
Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
Initial Date of Registration : 2020-08-05
Latest Date of Registration : 2020-08-05
Registration Number : 229MF10166
Registrant's Address : Glenmark House, HDO Corporate Building, Wing A, B. D. Sawant Marg, Chakala, Off Weste...
Initial Date of Registration : 2017-08-22
Latest Date of Registration : 2018-05-21
Registration Number : 225MF10153
Registrant's Address : 1A, Sector 16A, Noida 201 301, Uttar Pradesh, India
Initial Date of Registration : 2013-08-09
Latest Date of Registration : 2014-11-17
A Linezolid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Linezolid, including repackagers and relabelers. The FDA regulates Linezolid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Linezolid 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 Linezolid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Linezolid supplier is an individual or a company that provides Linezolid active pharmaceutical ingredient (API) or Linezolid finished formulations upon request. The Linezolid suppliers may include Linezolid API manufacturers, exporters, distributors and traders.
click here to find a list of Linezolid 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 Linezolid Drug Master File in Japan (Linezolid JDMF) empowers Linezolid 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 Linezolid JDMF during the approval evaluation for pharmaceutical products. At the time of Linezolid 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 Linezolid suppliers with JDMF on PharmaCompass.
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