01 1Kyungbo Pharmaceutical Co., Ltd.
02 2Lee Pharma Limited
03 1Lee Pharma Limited@Benova Labs Private Limited@SVR Drugs Private Limited
04 1Pfizer Asia Manufacturing Pte. Ltd.
05 1Symed Labs Limited (Unit II)
06 1Zhejiang Changhai Pharmaceuticals Co., Ltd.
01 1Ace Biopharm Co., Ltd.
02 1Grace Farm
03 1Korea Pfizer Pharmaceutical Co., Ltd.
04 1Kyungbo Pharmaceutical Co., Ltd.
05 1Lee Sung International Co., Ltd.
06 1Toru Corporation
07 1Youngjin Pharmaceutical Co., Ltd.
01 7Linezolid
01 1China
02 4India
03 1South Korea
04 1U.S.A
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2018-07-03
Registration Number : 20180703-209-J-76
Manufacturer Name : Kyungbo Pharmaceutical Co., ...
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do
Registrant Name : Toru Corporation
Registration Date : 2022-07-08
Registration Number : 20210623-209-J-1035(1)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No. 10/G-1, Gaddapotharam Village Jinnaram Mandal, Sangareddy District Telanga...
Registrant Name : Grace Farm
Registration Date : 2021-06-23
Registration Number : 20210623-209-J-1035
Manufacturer Name : Lee Pharma Limited@Benova La...
Manufacturer Address : Survey No. 10/G-1, Gaddapotharam Village Jinnaram Mandal, Sangareddy District Telanga...
Registrant Name : Youngjin Pharmaceutical Co., Ltd.
Registration Date : 2022-10-31
Registration Number : 20210623-209-J-1035(2)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No. 10/G-1, Gaddapotharam Village Jinnaram Mandal, Sangareddy District Telanga...
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-209-J-414
Manufacturer Name : Pfizer Asia Manufacturing Pt...
Manufacturer Address : 31 Tuas South Avenue 6 Singapore
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2021-03-10
Registration Number : 20210310-209-J-868
Manufacturer Name : Symed Labs Limited (Unit II)
Manufacturer Address : Plot-25/B, Phase III, IDA Jeedimetla (V), Quthbullapur (M), Medchal-Malkajgiri Distri...
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2022-09-02
Registration Number : 20220902-209-J-1354
Manufacturer Name : Zhejiang Changhai Pharmaceut...
Manufacturer Address : 188 Mid Zhiyuan Avenue, Binhai New Area, Shaoxing City, Zhejiang Province, 312366, PR...
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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Linezolid Drug Master File in Korea (Linezolid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Linezolid. The MFDS reviews the Linezolid KDMF as part of the drug registration process and uses the information provided in the Linezolid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Linezolid KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Linezolid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Linezolid suppliers with KDMF on PharmaCompass.
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