01 1BASF Corporation
02 1SI Group, Inc.
03 1Sogo Pharmaceutical Co., Ltd.
04 1Solara Active Pharma Sciences Limited
01 2Ibuprofen
02 1Ibuprofen Ibuprofen
03 1Ibuprofen pico Nord
01 1Germany
02 1India
03 1Japan
04 1U.S.A
Registration Number : 217MF10984
Registrant's Address : 100 Park Avenue, Florham Park, New Jersey, 07932, United States of America
Initial Date of Registration : 2005-11-21
Latest Date of Registration : 2009-12-18
Registration Number : 223MF10148
Registrant's Address : 1-8-2 Marunouchi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2011-09-30
Latest Date of Registration : 2011-09-30
Registration Number : 220MF10020
Registrant's Address : “Batra Centre”, 28, Sardar Patel Road, Guindy, Chennai-600 032, India
Initial Date of Registration : 2008-01-09
Latest Date of Registration : 2017-02-15
Registration Number : 219MF10324
Registrant's Address : 1790 Hughes Landing Blvd Suite 600, The Woodlands, TX 77380 US
Initial Date of Registration : 2007-10-24
Latest Date of Registration : 2012-12-26
A Alaxan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alaxan, including repackagers and relabelers. The FDA regulates Alaxan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alaxan 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 Alaxan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alaxan supplier is an individual or a company that provides Alaxan active pharmaceutical ingredient (API) or Alaxan finished formulations upon request. The Alaxan suppliers may include Alaxan API manufacturers, exporters, distributors and traders.
click here to find a list of Alaxan 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 Alaxan Drug Master File in Japan (Alaxan JDMF) empowers Alaxan 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 Alaxan JDMF during the approval evaluation for pharmaceutical products. At the time of Alaxan 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 Alaxan suppliers with JDMF on PharmaCompass.
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