01 1Daebong LS Co., Ltd. @ [Tobramycin Manufacturing Plant] Livzon New North River Pharmaceutical Co., Ltd
01 1Daebong LS Co., Ltd.
01 1Tobramycin sulfate
01 1South Korea
Registrant Name : Daebong LS Co., Ltd.
Registration Date : 2020-07-16
Registration Number : 20200716-91-E-166-06
Manufacturer Name : Daebong LS Co., Ltd. @ [Tobr...
Manufacturer Address : 123, Neungheodae-ro 649beon-gil, Namdong-gu, Incheon Metropolitan City @ [Tobramycin ...
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A Nebcine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nebcine, including repackagers and relabelers. The FDA regulates Nebcine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nebcine 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 Nebcine supplier is an individual or a company that provides Nebcine active pharmaceutical ingredient (API) or Nebcine finished formulations upon request. The Nebcine suppliers may include Nebcine 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 Nebcine Drug Master File in Korea (Nebcine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nebcine. The MFDS reviews the Nebcine KDMF as part of the drug registration process and uses the information provided in the Nebcine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nebcine 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 Nebcine API can apply through the Korea Drug Master File (KDMF).
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