Moehs Group, a reference company in the production of pharmaceutical active ingredients.
01 1MOEHS IBERICA S. L.
02 1Cambrex Karlskoga AB
03 1SperaNexus Inc.
01 1LIDOCAINE HYDROCHLORIDE
02 2Lidocaine hydrochloride
01 1Japan
02 1Spain
03 1U.S.A
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Registration Number : 219MF10205
Registrant's Address : Cesar Martinell i Brunet 12A, Poligono Rubi Sur, Rubi (Barcelona), Spain
Initial Date of Registration : 2007-06-13
Latest Date of Registration : 2021-04-02
Registration Number : 218MF10963
Registrant's Address : SE-691 85 Karlskoga, SWEDEN
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2006-12-01
Registration Number : 217MF10050
Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2009-01-28
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A Xylestesin hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xylestesin hydrochloride, including repackagers and relabelers. The FDA regulates Xylestesin hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xylestesin 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.
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A Xylestesin hydrochloride supplier is an individual or a company that provides Xylestesin hydrochloride active pharmaceutical ingredient (API) or Xylestesin hydrochloride finished formulations upon request. The Xylestesin hydrochloride suppliers may include Xylestesin hydrochloride API manufacturers, exporters, distributors and traders.
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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 Xylestesin hydrochloride Drug Master File in Japan (Xylestesin hydrochloride JDMF) empowers Xylestesin 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 Xylestesin hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Xylestesin hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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