01 1Boryeong Co., Ltd.
02 1H.L.G.Nomics Co., Ltd.
03 1JDW Pharmaceutical Co., Ltd.
04 1Kolon Life Science Co., Ltd.
05 1Korea Biochem Pharmaceutical Co., Ltd.
06 2Kyungbo Pharmaceutical Co., Ltd.
07 1Kyungdong Pharmaceutical Co., Ltd.
08 1MFC Corporation
09 3MSN Laboratories PVT.LTD
10 1Onoda Plant, Nissan Chemical Corporation
11 1Polaris AI Pharma Co., Ltd.
12 1Shaoxing Jingxin Pharmaceutical Co., Ltd
13 4Solara Active Pharma Sciences Limited
01 1Boryeong Co., Ltd.
02 1Chodang Pharmaceutical Industry Co., Ltd.
03 1Dongkwang Pharmaceutical Co., Ltd.
04 1H.L.G.Nomics Co., Ltd.
05 1Hanyoung Farm Co., Ltd.
06 2JDW Pharmaceutical Co., Ltd.
07 1Kolon Life Science Co., Ltd.
08 1Korea Biochem Pharmaceutical Co., Ltd.
09 1Kukjeon Pharmaceutical Co., Ltd.
10 2Kyungbo Pharmaceutical Co., Ltd.
11 1Kyungdong Pharmaceutical Co., Ltd.
12 1MFC Corporation
13 1Masung LS Co., Ltd.
14 1Otran Pharm Korea Co., Ltd.
15 1Pharmapia Co., Ltd.
16 1Pharmasolution Co., Ltd.
17 1Polaris AI Pharma Co., Ltd.
01 8pitavastatin calcium
02 11pitavastatin calcium hydrate
01 1China
02 7India
03 1Japan
04 10South Korea
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2019-04-10
Registration Number : 1689-5-ND
Manufacturer Name : Boryeong Co., Ltd.
Manufacturer Address : 107, 109 Neungan-ro, Danwon-gu, Ansan-si, Gyeonggi-do
Registrant Name : Kolon Life Science Co., Ltd.
Registration Date : 2020-01-13
Registration Number : 1607-1-ND
Manufacturer Name : Kolon Life Science Co., Ltd.
Manufacturer Address : 54, Gipyodosi 1-ro, Daesowon-myeon, Chungju-si, Chungcheongbuk-do
Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.
Registration Date : 2021-06-22
Registration Number : 2152-12-ND
Manufacturer Name : Korea Biochem Pharmaceutical...
Manufacturer Address : 204 Sandan-gil, Jeonui-myeon, Sejong Special Self-Governing City
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2021-12-01
Registration Number : 1673-49-ND
Manufacturer Name : Kyungbo Pharmaceutical Co., ...
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do
Registrant Name : Kyungdong Pharmaceutical Co., Ltd.
Registration Date : 2020-01-30
Registration Number : 1574-8-ND
Manufacturer Name : Kyungdong Pharmaceutical Co....
Manufacturer Address : 15, Balan Industrial Complex Road 2-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : MFC Corporation
Registration Date : 2017-01-09
Registration Number : 346-1-ND
Manufacturer Name : MFC Corporation
Manufacturer Address : 35 Cheongwon Industrial Complex 7-gil, Mado-myeon, Hwaseong-si, Gyeonggi-do
Registrant Name : Hanyoung Farm Co., Ltd.
Registration Date : 2022-07-18
Registration Number : No. 2816-6-ND(3)
Manufacturer Name : Solara Active Pharma Science...
Manufacturer Address : A-1/B, Sipcot Industrial Complex Kudikadu Village, Cuddalore - 607 005 Tamilnadu, Ind...
Registrant Name : Chodang Pharmaceutical Industry Co., Ltd.
Registration Date : 2020-01-13
Registration Number : No. 2816-6-ND(1)
Manufacturer Name : Solara Active Pharma Science...
Manufacturer Address : A-1/B, Sipcot Industrial Complex Kudikadu Village, Cuddalore - 607 005 Tamilnadu, Ind...
Registrant Name : Pharmasolution Co., Ltd.
Registration Date : 2021-03-18
Registration Number : No. 2816-6-ND(A)
Manufacturer Name : Solara Active Pharma Science...
Manufacturer Address : A-1/B, Sipcot Industrial Complex Kudikadu Village, Cuddalore - 607 005 Tamilnadu, Ind...
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2023-01-11
Registration Number : No. 695-15-ND
Manufacturer Name : Shaoxing Jingxin Pharmaceuti...
Manufacturer Address : No. 31 Weisan Road, Hangzhou Bay, Shangyu Economic and Technological Development Area...
A Redevant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Redevant, including repackagers and relabelers. The FDA regulates Redevant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Redevant 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 Redevant supplier is an individual or a company that provides Redevant active pharmaceutical ingredient (API) or Redevant finished formulations upon request. The Redevant suppliers may include Redevant API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Redevant Drug Master File in Korea (Redevant KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Redevant. The MFDS reviews the Redevant KDMF as part of the drug registration process and uses the information provided in the Redevant KDMF to evaluate the safety and efficacy of the drug.
After submitting a Redevant 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 Redevant API can apply through the Korea Drug Master File (KDMF).
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