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01 1EUROAPI FRANCE
02 2Tianjin Jinjin Pharmaceutical Co. , Ltd.
03 1Zhejiang Langhua Pharmaceutical Co. , Ltd.
01 4Spironolactone
01 3China
02 1France
Registration Number : 218MF10382
Registrant's Address : 15 rue Traversie(')re 75012 Paris France
Initial Date of Registration : 2006-03-20
Latest Date of Registration : 2019-11-15
Registration Number : 220MF10037
Registrant's Address : Industrial zone of Zhangjiawo Town, Xiqing District Economic & Developing Area, Tianj...
Initial Date of Registration : 2008-02-05
Latest Date of Registration : 2008-02-05
Registration Number : 227MF10291
Registrant's Address : Industrial zone of Zhangjiawo Town, Xiqing District Economic & Developing Area, Tianj...
Initial Date of Registration : 2015-12-24
Latest Date of Registration : 2015-12-24
Registration Number : 231MF10058
Registrant's Address : Zhejiang provincial chemical and medical materials base Linhai zone, Linhai, Zhejiang...
Initial Date of Registration : 2019-02-25
Latest Date of Registration : 2019-02-25
A Spiractin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spiractin, including repackagers and relabelers. The FDA regulates Spiractin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spiractin 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 Spiractin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Spiractin supplier is an individual or a company that provides Spiractin active pharmaceutical ingredient (API) or Spiractin finished formulations upon request. The Spiractin suppliers may include Spiractin API manufacturers, exporters, distributors and traders.
click here to find a list of Spiractin 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 Spiractin Drug Master File in Japan (Spiractin JDMF) empowers Spiractin 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 Spiractin JDMF during the approval evaluation for pharmaceutical products. At the time of Spiractin 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 Spiractin suppliers with JDMF on PharmaCompass.
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