01 1CHEMI S. p. A.
02 1DIVI'S LABORATORIES LIMITED
01 2Nabumetone
01 1India
02 1Italy
Registration Number : 224MF10109
Registrant's Address : Viale dei Laboratori 54, 20092 Cinisello Balsamo (Milano), Italy
Initial Date of Registration : 2012-06-22
Latest Date of Registration : 2012-06-22
Registration Number : 228MF10204
Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers Cyber Hills, Gachibowli Hyderabad - 500 032 T...
Initial Date of Registration : 2016-10-31
Latest Date of Registration : 2016-10-31
A Nabumetone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nabumetone, including repackagers and relabelers. The FDA regulates Nabumetone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nabumetone 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 Nabumetone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nabumetone supplier is an individual or a company that provides Nabumetone active pharmaceutical ingredient (API) or Nabumetone finished formulations upon request. The Nabumetone suppliers may include Nabumetone API manufacturers, exporters, distributors and traders.
click here to find a list of Nabumetone 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 Nabumetone Drug Master File in Japan (Nabumetone JDMF) empowers Nabumetone 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 Nabumetone JDMF during the approval evaluation for pharmaceutical products. At the time of Nabumetone 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 Nabumetone suppliers with JDMF on PharmaCompass.
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