01 1Kyowa Pharma Chemical Co., Ltd.
02 1R-Tech Ueno Co., Ltd.
03 1Sucampo Pharma LLC
04 1YS Life Science Co. , Ltd.
01 2Lubiprostone
02 1Lubiprostone (for manufacturing only)
03 1Preparations for the production of lubiprostone
01 3Japan
02 1South Korea
Lubiprostone (for manufacturing purposes only)
Registration Number : 304MF10149
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2022-11-30
Latest Date of Registration : 2022-11-30
Lubiprostone for pharmaceutical manufacturing
Registration Number : 224MF10099
Registrant's Address : 1-11-1 Marunouchi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2012-05-15
Latest Date of Registration : 2012-05-15
Registration Number : 222MF10205
Registrant's Address : 1-1-7 Uchisaiwaicho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2010-07-21
Latest Date of Registration : 2010-07-21
Registration Number : 305MF10013
Registrant's Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea
Initial Date of Registration : 2023-02-02
Latest Date of Registration : 2023-02-02
A Lubiprostone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lubiprostone, including repackagers and relabelers. The FDA regulates Lubiprostone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lubiprostone 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 Lubiprostone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lubiprostone supplier is an individual or a company that provides Lubiprostone active pharmaceutical ingredient (API) or Lubiprostone finished formulations upon request. The Lubiprostone suppliers may include Lubiprostone API manufacturers, exporters, distributors and traders.
click here to find a list of Lubiprostone 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 Lubiprostone Drug Master File in Japan (Lubiprostone JDMF) empowers Lubiprostone 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 Lubiprostone JDMF during the approval evaluation for pharmaceutical products. At the time of Lubiprostone 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 Lubiprostone suppliers with JDMF on PharmaCompass.
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