01 1Pharmacia & Upjohn Company LLC
01 1Novartis Korea
01 1Neomycin sulfate
01 1U.S.A
Registrant Name : Novartis Korea
Registration Date : 2023-08-01
Registration Number : 20230801-211-J-1531
Manufacturer Name : Pharmacia & Upjohn Company L...
Manufacturer Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA
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A NEOSPORIN G.U. IRRIGANT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NEOSPORIN G.U. IRRIGANT, including repackagers and relabelers. The FDA regulates NEOSPORIN G.U. IRRIGANT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NEOSPORIN G.U. IRRIGANT 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 NEOSPORIN G.U. IRRIGANT supplier is an individual or a company that provides NEOSPORIN G.U. IRRIGANT active pharmaceutical ingredient (API) or NEOSPORIN G.U. IRRIGANT finished formulations upon request. The NEOSPORIN G.U. IRRIGANT suppliers may include NEOSPORIN G.U. IRRIGANT 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 NEOSPORIN G.U. IRRIGANT Drug Master File in Korea (NEOSPORIN G.U. IRRIGANT KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of NEOSPORIN G.U. IRRIGANT. The MFDS reviews the NEOSPORIN G.U. IRRIGANT KDMF as part of the drug registration process and uses the information provided in the NEOSPORIN G.U. IRRIGANT KDMF to evaluate the safety and efficacy of the drug.
After submitting a NEOSPORIN G.U. IRRIGANT 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 NEOSPORIN G.U. IRRIGANT API can apply through the Korea Drug Master File (KDMF).
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