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
A Cinacalcet manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cinacalcet, including repackagers and relabelers. The FDA regulates Cinacalcet manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cinacalcet 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 Cinacalcet manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cinacalcet supplier is an individual or a company that provides Cinacalcet active pharmaceutical ingredient (API) or Cinacalcet finished formulations upon request. The Cinacalcet suppliers may include Cinacalcet API manufacturers, exporters, distributors and traders.
click here to find a list of Cinacalcet 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 Drug Master File in Japan (Cinacalcet JDMF) empowers Cinacalcet 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Cinacalcet 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 suppliers with JDMF on PharmaCompass.
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