01 1MOLCLONE LABS PRIVATE LIMITED
01 1Agerson Bio Co., Ltd.
01 1sodium levofolinate
01 1India
Registrant Name : Agerson Bio Co., Ltd.
Registration Date : 2025-04-21
Registration Number : 20250421-210-J-1540
Manufacturer Name : MOLCLONE LABS PRIVATE LIMITE...
Manufacturer Address : No. 2/22 (SURVEY NO. 173/1A, 173/2 AND 173/3), SIRUMATHUR VALLAGE, PADAPPAI, SRIPERUM...
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A Levofolene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levofolene, including repackagers and relabelers. The FDA regulates Levofolene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levofolene 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 Levofolene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Levofolene supplier is an individual or a company that provides Levofolene active pharmaceutical ingredient (API) or Levofolene finished formulations upon request. The Levofolene suppliers may include Levofolene API manufacturers, exporters, distributors and traders.
click here to find a list of Levofolene 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 Levofolene Drug Master File in Korea (Levofolene KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Levofolene. The MFDS reviews the Levofolene KDMF as part of the drug registration process and uses the information provided in the Levofolene KDMF to evaluate the safety and efficacy of the drug.
After submitting a Levofolene 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 Levofolene API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Levofolene suppliers with KDMF on PharmaCompass.
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