01 1Cambrex Karlskoga AB
01 1Bupivacaine hydrochloride
01 1U.S.A
Registration Number : 218MF10875
Registrant's Address : SE-691 85 Karlskoga, SWEDEN
Initial Date of Registration : 2006-11-10
Latest Date of Registration : 2018-04-23
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Marcaine Drug Master File in Japan (Marcaine JDMF) empowers Marcaine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Marcaine JDMF during the approval evaluation for pharmaceutical products. At the time of Marcaine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Marcaine suppliers with JDMF on PharmaCompass.
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