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