01 1CHONGQING SHENGHUAXI PHARMACEUTICAL CO. , LTD.
02 2Chongqing Shenghuaxi Pharmaceutical Co. ,Ltd
03 1ESTECHPHARMA CO. , LTD.
04 1Polaris AI Pharma Corp.
01 5Droxidopa
01 3China
02 2South Korea
Registration Number : 218MF10680
Registrant's Address : Renjiawan, Dashiba, Nan an Chongqing 40006, China
Initial Date of Registration : 2006-08-11
Latest Date of Registration : 2006-08-11
Registration Number : 218MF10452
Registrant's Address : Rejiawan, Dashiba, Nan an, Chongqing China
Initial Date of Registration : 2006-04-27
Latest Date of Registration : 2007-02-13
Registration Number : 222MF10282
Registrant's Address : No. 8 Jiangqiao Road, Nan an District Chongqing China
Initial Date of Registration : 2010-12-24
Latest Date of Registration : 2010-12-24
Registration Number : 228MF10144
Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2016-08-03
Latest Date of Registration : 2016-08-03
Registration Number : 221MF10115
Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2009-06-16
Latest Date of Registration : 2009-06-16
A Northera manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Northera, including repackagers and relabelers. The FDA regulates Northera manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Northera 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 Northera manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Northera supplier is an individual or a company that provides Northera active pharmaceutical ingredient (API) or Northera finished formulations upon request. The Northera suppliers may include Northera API manufacturers, exporters, distributors and traders.
click here to find a list of Northera 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 Northera Drug Master File in Japan (Northera JDMF) empowers Northera 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 Northera JDMF during the approval evaluation for pharmaceutical products. At the time of Northera 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 Northera suppliers with JDMF on PharmaCompass.
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