01 1HETERO DRUGS LIMITED.
02 1JEIL PHARMACEUTICAL CO. , LTD.
03 1KUKJEON PHARMACEUTICAL Co. , Ltd.
04 1Sanyo Chemical Research Institute Co., Ltd.
01 3Cinacalcet Hydrochloride
02 1Cinacalcet hydrochloride
01 1Gabon
02 1India
03 2South Korea
Registration Number : 230MF10003
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...
Initial Date of Registration : 2018-01-10
Latest Date of Registration : 2018-01-10
Registration Number : 301MF10033
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2019-07-19
Latest Date of Registration : 2019-07-19
Registration Number : 230MF10125
Registrant's Address : #1516, Geumgang Penterium IT Tower, 282, Hagui-ro, Dongan-gu, Anyang-si, Gyeonggi-do,...
Initial Date of Registration : 2018-09-03
Latest Date of Registration : 2020-03-02
Registration Number : 301MF10098
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2019-11-27
Latest Date of Registration : 2019-11-27
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PharmaCompass offers a list of Cinacalcet 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 Cinacalcet manufacturer or Cinacalcet supplier for your needs.
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A Cinacalcet HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cinacalcet HCl, including repackagers and relabelers. The FDA regulates Cinacalcet HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cinacalcet HCl 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 Cinacalcet HCl supplier is an individual or a company that provides Cinacalcet HCl active pharmaceutical ingredient (API) or Cinacalcet HCl finished formulations upon request. The Cinacalcet HCl suppliers may include Cinacalcet HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Cinacalcet HCl 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 Cinacalcet HCl Drug Master File in Japan (Cinacalcet HCl JDMF) empowers Cinacalcet HCl 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 Cinacalcet HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Cinacalcet HCl 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 Cinacalcet HCl suppliers with JDMF on PharmaCompass.
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