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 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.
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 Bupivacaine Hydrochloride Drug Master File in Japan (Bupivacaine Hydrochloride JDMF) empowers Bupivacaine Hydrochloride 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 Bupivacaine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Bupivacaine Hydrochloride 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 Bupivacaine Hydrochloride suppliers with JDMF on PharmaCompass.
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