01 1Aurobindo Pharma Limited
02 1YS Life Science Co. , Ltd.
01 2Pramipexole hydrochloride hydrate
01 1India
02 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 : 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
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PharmaCompass offers a list of Pramipexole Dihydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pramipexole Dihydrochloride manufacturer or Pramipexole Dihydrochloride supplier for your needs.
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A Pramipexole Dihydrochloride Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pramipexole Dihydrochloride Monohydrate, including repackagers and relabelers. The FDA regulates Pramipexole Dihydrochloride Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pramipexole Dihydrochloride Monohydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Pramipexole Dihydrochloride Monohydrate supplier is an individual or a company that provides Pramipexole Dihydrochloride Monohydrate active pharmaceutical ingredient (API) or Pramipexole Dihydrochloride Monohydrate finished formulations upon request. The Pramipexole Dihydrochloride Monohydrate suppliers may include Pramipexole Dihydrochloride Monohydrate API manufacturers, exporters, distributors and traders.
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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 Dihydrochloride Monohydrate Drug Master File in Japan (Pramipexole Dihydrochloride Monohydrate JDMF) empowers Pramipexole Dihydrochloride Monohydrate 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 Dihydrochloride Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Pramipexole Dihydrochloride Monohydrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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