01 2Changshan Seika Pharmaceutical (Jiangsu) Co., Ltd.
02 1Changzhou Qianhong Biopharma Co. , Ltd.
03 1Changzhou Tianpu Pharmaceutical Co., Ltd.
04 1Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd.
05 1OPOCRIN S. p. A.
01 1Dalteparin Sodium
02 5Dalteparin sodium
01 4China
02 1Italy
03 1Blank
Registration Number : 301MF10042
Registrant's Address : No. 18 Guoxiang Road, Wujin Economic Development Zone, Changzhou City, Jiangsu Provin...
Initial Date of Registration : 2019-08-09
Latest Date of Registration : 2019-08-09
Registration Number : 223MF10084
Registrant's Address : No. 18 Guoxiang Road, Wujin Economic Development Zone, Changzhou City, Jiangsu Provin...
Initial Date of Registration : 2011-06-17
Latest Date of Registration : 2019-01-10
Registration Number : 218MF10583
Registrant's Address : No. 1, Changhong West Road, Hutang Town, Wujin District, Changzhou City, Jiangsu Prov...
Initial Date of Registration : 2006-06-22
Latest Date of Registration : 2009-12-25
Registration Number : 219MF10099
Registrant's Address : No. 192 Huanghe West Rd. Xinbei District Changzhou, Jiangsu, China
Initial Date of Registration : 2007-03-14
Latest Date of Registration : 2014-05-21
Registration Number : 227MF10152
Registrant's Address : Via Pacinotti, 3 41043 Corlo di Formigine (Modena) Italy
Initial Date of Registration : 2015-06-01
Latest Date of Registration : 2015-06-01
Registration Number : 221MF10099
Registrant's Address : Nanjing High-tech Development Zone MA010-1
Initial Date of Registration : 2009-05-27
Latest Date of Registration : 2022-07-06
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PharmaCompass offers a list of Dalteparin sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dalteparin sodium manufacturer or Dalteparin sodium supplier for your needs.
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A Heparinum natricum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Heparinum natricum, including repackagers and relabelers. The FDA regulates Heparinum natricum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Heparinum natricum 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 Heparinum natricum supplier is an individual or a company that provides Heparinum natricum active pharmaceutical ingredient (API) or Heparinum natricum finished formulations upon request. The Heparinum natricum suppliers may include Heparinum natricum 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 Heparinum natricum Drug Master File in Japan (Heparinum natricum JDMF) empowers Heparinum natricum 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 Heparinum natricum JDMF during the approval evaluation for pharmaceutical products. At the time of Heparinum natricum 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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