01 1Aesica Queenborough Ltd.
02 1Shiono Finesse Co., Ltd.
01 1Hydrochloric acid levobupivacaine
02 1Levobupivacaine hydrochloride
01 1Japan
02 1United Kingdom
Registration Number : 218MF10003
Registrant's Address : Queenborough, Kent ME11 5EL, United Kingdom
Initial Date of Registration : 2006-01-06
Latest Date of Registration : 2017-02-28
Registration Number : 225MF10165
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 3-1-6
Initial Date of Registration : 2013-08-23
Latest Date of Registration : 2014-10-27
A Levobupivacaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levobupivacaine, including repackagers and relabelers. The FDA regulates Levobupivacaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levobupivacaine 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 Levobupivacaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levobupivacaine supplier is an individual or a company that provides Levobupivacaine active pharmaceutical ingredient (API) or Levobupivacaine finished formulations upon request. The Levobupivacaine suppliers may include Levobupivacaine API manufacturers, exporters, distributors and traders.
click here to find a list of Levobupivacaine 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 Levobupivacaine Drug Master File in Japan (Levobupivacaine JDMF) empowers Levobupivacaine 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 Levobupivacaine JDMF during the approval evaluation for pharmaceutical products. At the time of Levobupivacaine 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 Levobupivacaine suppliers with JDMF on PharmaCompass.
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