01 1Jeil Pharmaceutical Co., Ltd.
02 1Otsuka Pharmaceutial Co., Ltd (Tolbantan Spray Dry Powder Manufacturing Plant) @Otsuka Pharmaceutial Co., Ltd (Tolbantan Manufacturing Plant)
01 1Jeil Pharmaceutical Co., Ltd.
02 1Korea Otsuka Pharmaceutical Co., Ltd.
01 1Tolbaptan
02 1Tolbaptan spray dried powder
01 1Italy
02 1South Korea
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2019-09-02
Registration Number : 1668-23-ND
Manufacturer Name : Jeil Pharmaceutical Co., Ltd...
Manufacturer Address : 7, Cheonggang-ga-chang-ro, Baekam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do (B-dong an...
Registrant Name : Korea Otsuka Pharmaceutical Co., Ltd.
Registration Date : 2011-08-19
Registration Number : 2662-2-ND
Manufacturer Name : Otsuka Pharmaceutial Co., Lt...
Manufacturer Address : 463-10, Kagasuno, Kawauchi-cho, Tokushima-shi, Tokushima@224-18 Hiraishi Ebisuno, Kaw...
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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Tolvaptan Drug Master File in Korea (Tolvaptan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tolvaptan. The MFDS reviews the Tolvaptan KDMF as part of the drug registration process and uses the information provided in the Tolvaptan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tolvaptan KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Tolvaptan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tolvaptan suppliers with KDMF on PharmaCompass.
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