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
93
PharmaCompass offers a list of Meglumine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Meglumine manufacturer or Meglumine supplier for your needs.
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A N-Methyl-D-Glucamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-Methyl-D-Glucamine, including repackagers and relabelers. The FDA regulates N-Methyl-D-Glucamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-Methyl-D-Glucamine 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 N-Methyl-D-Glucamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A N-Methyl-D-Glucamine supplier is an individual or a company that provides N-Methyl-D-Glucamine active pharmaceutical ingredient (API) or N-Methyl-D-Glucamine finished formulations upon request. The N-Methyl-D-Glucamine suppliers may include N-Methyl-D-Glucamine API manufacturers, exporters, distributors and traders.
click here to find a list of N-Methyl-D-Glucamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 N-Methyl-D-Glucamine Drug Master File in Korea (N-Methyl-D-Glucamine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of N-Methyl-D-Glucamine. The MFDS reviews the N-Methyl-D-Glucamine KDMF as part of the drug registration process and uses the information provided in the N-Methyl-D-Glucamine KDMF to evaluate the safety and efficacy of the drug.
After submitting a N-Methyl-D-Glucamine 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 N-Methyl-D-Glucamine API can apply through the Korea Drug Master File (KDMF).
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