01 1HETERO DRUGS LIMITED.
02 1Hamari PFST Co., Ltd.
03 1JEIL PHARMACEUTICAL CO. , LTD.
04 1Shin Poong Pharm. Co. , Ltd.
05 1Shiratori Pharmaceutical Co., Ltd.
06 2Shizuoka Caffeine Industry Co., Ltd.
07 1Syn-Tech Chem. & Pharm. Co. , Ltd.
01 1Dedicated to tolvaptan production
02 4Tolvaptan
03 1Tolvaptan "D"
04 1Tolvaptan (amorphous) (manufacturing only)
05 1Tolvaptan (manufacturing only)
01 1India
02 4Japan
03 2South Korea
04 1Taiwan
Registration Number : 303MF10018
Registrant's Address : Osaka Prefecture, Osaka City, Suminoe Ward, Nanko Kita 1-19-40
Initial Date of Registration : 2021-01-26
Latest Date of Registration : 2021-01-26
Registration Number : 301MF10051
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...
Initial Date of Registration : 2019-08-20
Latest Date of Registration : 2019-08-20
Registration Number : 303MF10006
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2021-01-14
Latest Date of Registration : 2021-01-14
Registration Number : 303MF10013
Registrant's Address : 161, Yeoksam-ro, Gangnam-gu, Seoul, Korea
Initial Date of Registration : 2021-01-26
Latest Date of Registration : 2021-01-26
Registration Number : 302MF10134
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2020-11-04
Latest Date of Registration : 2020-11-04
Tolvaptan (for manufacturing only)
Registration Number : 302MF10158
Registrant's Address : 129 Suidocho, Aoi Ward, Shizuoka City, Shizuoka Prefecture
Initial Date of Registration : 2020-12-23
Latest Date of Registration : 2021-02-05
Tolvaptan (amorphous) (for manufacturing purposes only)
Registration Number : 303MF10049
Registrant's Address : 129 Suidocho, Aoi Ward, Shizuoka City, Shizuoka Prefecture
Initial Date of Registration : 2021-03-22
Latest Date of Registration : 2021-03-22
Registration Number : 302MF10031
Registrant's Address : No. 168 Kai-Yuan Rd. , Hsin-Ying Tainan City, 73055. Taiwan
Initial Date of Registration : 2020-02-20
Latest Date of Registration : 2020-02-20
A Tolvaptan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tolvaptan, including repackagers and relabelers. The FDA regulates Tolvaptan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tolvaptan 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 Tolvaptan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tolvaptan supplier is an individual or a company that provides Tolvaptan active pharmaceutical ingredient (API) or Tolvaptan finished formulations upon request. The Tolvaptan suppliers may include Tolvaptan API manufacturers, exporters, distributors and traders.
click here to find a list of Tolvaptan 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 Tolvaptan Drug Master File in Japan (Tolvaptan JDMF) empowers Tolvaptan 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 Tolvaptan JDMF during the approval evaluation for pharmaceutical products. At the time of Tolvaptan 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 Tolvaptan suppliers with JDMF on PharmaCompass.
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