01 1DaeHe Biopharma Co. , Ltd.
02 1Ryoto Fine Co., Ltd.
01 2Ampiroxicam
01 1Japan
02 1South Korea
Registration Number : 222MF10131
Registrant's Address : Hyeomnyeok-ro 150, Siheung city, Gyeonggi-do, KOREA
Initial Date of Registration : 2010-04-12
Latest Date of Registration : 2010-04-12
Registration Number : 225MF10195
Registrant's Address : 1410 Takada, Kashiwa City, Chiba Prefecture
Initial Date of Registration : 2013-10-23
Latest Date of Registration : 2013-10-23
A Ampiroxicam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ampiroxicam, including repackagers and relabelers. The FDA regulates Ampiroxicam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ampiroxicam API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Ampiroxicam supplier is an individual or a company that provides Ampiroxicam active pharmaceutical ingredient (API) or Ampiroxicam finished formulations upon request. The Ampiroxicam suppliers may include Ampiroxicam API manufacturers, exporters, distributors and traders.
click here to find a list of Ampiroxicam 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 Ampiroxicam Drug Master File in Japan (Ampiroxicam JDMF) empowers Ampiroxicam 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 Ampiroxicam JDMF during the approval evaluation for pharmaceutical products. At the time of Ampiroxicam 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 Ampiroxicam suppliers with JDMF on PharmaCompass.
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