01 1MSN Laboratories Private Limited.
02 1Tateyama Chemical Co., Ltd.
01 1Ambrisentan
02 1Ambrisentan
01 1India
02 1Japan
Registration Number : 302MF10087
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2020-07-22
Latest Date of Registration : 2021-05-10
Registration Number : 302MF10090
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2020-07-29
Latest Date of Registration : 2022-01-11
A Ambrisentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ambrisentan, including repackagers and relabelers. The FDA regulates Ambrisentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ambrisentan 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 Ambrisentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ambrisentan supplier is an individual or a company that provides Ambrisentan active pharmaceutical ingredient (API) or Ambrisentan finished formulations upon request. The Ambrisentan suppliers may include Ambrisentan API manufacturers, exporters, distributors and traders.
click here to find a list of Ambrisentan 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 Ambrisentan Drug Master File in Japan (Ambrisentan JDMF) empowers Ambrisentan 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 Ambrisentan JDMF during the approval evaluation for pharmaceutical products. At the time of Ambrisentan 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 Ambrisentan suppliers with JDMF on PharmaCompass.
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