01 1Zenji Pharmaceuticals (Suzhou) Ltd.
01 1Leaders Bio Co., Ltd.
01 1Meglumine
01 1China
Registrant Name : Leaders Bio Co., Ltd.
Registration Date : 2018-07-21
Registration Number : 20180721-210-J-246
Manufacturer Name : Zenji Pharmaceuticals (Suzho...
Manufacturer Address : No.122, Xuqing Road, Xuguan Town, Suzhou, Jiangsu, China
A Meglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Meglumine, including repackagers and relabelers. The FDA regulates Meglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Meglumine 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 Meglumine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Meglumine supplier is an individual or a company that provides Meglumine active pharmaceutical ingredient (API) or Meglumine finished formulations upon request. The Meglumine suppliers may include Meglumine API manufacturers, exporters, distributors and traders.
click here to find a list of Meglumine 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 Meglumine Drug Master File in Korea (Meglumine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Meglumine. The MFDS reviews the Meglumine KDMF as part of the drug registration process and uses the information provided in the Meglumine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Meglumine 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 Meglumine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Meglumine suppliers with KDMF on PharmaCompass.
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