Moehs Group, a reference company in the production of pharmaceutical active ingredients.
01 1MOEHS IBERICA S. L.
02 1Ipca Laboratories Limited
03 1SperaNexus Inc.
01 3Metoprolol tartrate
01 1India
02 1Japan
03 1Spain
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Registration Number : 222MF10104
Registrant's Address : Cesar Martinell i Brunet 12A, Poligono Rubi Sur, Rubi (Barcelona), Spain
Initial Date of Registration : 2010-03-18
Latest Date of Registration : 2019-03-11
Registration Number : 221MF10151
Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, INDIA
Initial Date of Registration : 2009-07-09
Latest Date of Registration : 2009-07-09
Registration Number : 217MF10047
Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2008-01-10
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A Selo-Zok manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Selo-Zok, including repackagers and relabelers. The FDA regulates Selo-Zok manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Selo-Zok 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 Selo-Zok supplier is an individual or a company that provides Selo-Zok active pharmaceutical ingredient (API) or Selo-Zok finished formulations upon request. The Selo-Zok suppliers may include Selo-Zok 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 Selo-Zok Drug Master File in Japan (Selo-Zok JDMF) empowers Selo-Zok 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 Selo-Zok JDMF during the approval evaluation for pharmaceutical products. At the time of Selo-Zok 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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