01 1Aurobindo Pharma Limited
02 1Sanyo Chemical Research Institute Co., Ltd.
03 1YS Life Science Co. , Ltd.
01 3Pramipexole hydrochloride hydrate
01 1Gabon
02 1India
03 1South Korea
Pramipexole hydrochloride hydrate
Registration Number : 223MF10156
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Andhra Pradesh, India
Initial Date of Registration : 2011-11-02
Latest Date of Registration : 2012-10-31
Pramipexole hydrochloride hydrate
Registration Number : 223MF10154
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2011-11-02
Latest Date of Registration : 2012-11-01
Pramipexole hydrochloride hydrate
Registration Number : 223MF10181
Registrant's Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea
Initial Date of Registration : 2011-12-27
Latest Date of Registration : 2021-11-02
A Pramipexole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pramipexole, including repackagers and relabelers. The FDA regulates Pramipexole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pramipexole 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 Pramipexole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pramipexole supplier is an individual or a company that provides Pramipexole active pharmaceutical ingredient (API) or Pramipexole finished formulations upon request. The Pramipexole suppliers may include Pramipexole API manufacturers, exporters, distributors and traders.
click here to find a list of Pramipexole 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 Pramipexole Drug Master File in Japan (Pramipexole JDMF) empowers Pramipexole 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 Pramipexole JDMF during the approval evaluation for pharmaceutical products. At the time of Pramipexole 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 Pramipexole suppliers with JDMF on PharmaCompass.
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