01 1Cambrex Karlskoga AB
01 1Mitsubishi Tanabe Pharma Korea Co., Ltd.
01 1Bupivacaine hydrochloride hydrate
01 1U.S.A
Bupivacaine hydrochloride hydrate
Registrant Name : Mitsubishi Tanabe Pharma Korea Co., Ltd.
Registration Date : 2022-12-15
Registration Number : 20221215-210-J-1423
Manufacturer Name : Cambrex Karlskoga AB
Manufacturer Address : SE-691 85 Karlskoga, Sweden
A Marcaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Marcaine, including repackagers and relabelers. The FDA regulates Marcaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Marcaine 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 Marcaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Marcaine supplier is an individual or a company that provides Marcaine active pharmaceutical ingredient (API) or Marcaine finished formulations upon request. The Marcaine suppliers may include Marcaine API manufacturers, exporters, distributors and traders.
click here to find a list of Marcaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 Marcaine Drug Master File in Korea (Marcaine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Marcaine. The MFDS reviews the Marcaine KDMF as part of the drug registration process and uses the information provided in the Marcaine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Marcaine 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 Marcaine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Marcaine suppliers with KDMF on PharmaCompass.
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