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