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 Leucovorin Calcium Inj 10mg/ml manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leucovorin Calcium Inj 10mg/ml, including repackagers and relabelers. The FDA regulates Leucovorin Calcium Inj 10mg/ml manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leucovorin Calcium Inj 10mg/ml API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Leucovorin Calcium Inj 10mg/ml supplier is an individual or a company that provides Leucovorin Calcium Inj 10mg/ml active pharmaceutical ingredient (API) or Leucovorin Calcium Inj 10mg/ml finished formulations upon request. The Leucovorin Calcium Inj 10mg/ml suppliers may include Leucovorin Calcium Inj 10mg/ml API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Leucovorin Calcium Inj 10mg/ml Drug Master File in Korea (Leucovorin Calcium Inj 10mg/ml KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Leucovorin Calcium Inj 10mg/ml. The MFDS reviews the Leucovorin Calcium Inj 10mg/ml KDMF as part of the drug registration process and uses the information provided in the Leucovorin Calcium Inj 10mg/ml KDMF to evaluate the safety and efficacy of the drug.
After submitting a Leucovorin Calcium Inj 10mg/ml 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 Leucovorin Calcium Inj 10mg/ml API can apply through the Korea Drug Master File (KDMF).
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