01 2Alpinamed AG
02 1BIONORICA AG
03 1Borak Co., Ltd.
04 1Daepyeong Co., Ltd.
05 1Guangdong Qingyunshan Pharmaceutical Co., Ltd.
06 1Guangdong Qingyunshan Pharmaceutical Co.,Ltd.
07 1Hunan Jiudian Pharmaceutical.Co.,Ltd.
08 2Hunan Tianlong Pharmaceutical Co., Ltd.
09 1Hunan Warrant Pharmaceutical Co.,Ltd
10 1Hyundai Bioland Co., Ltd.
11 1Jing Brand Chizhengtang Pharmaceutical Co., Ltd.
12 1Ningbo Green-Health Pharmaceutical Co., Ltd.
13 1Ningbo Green-Heanlth Pharmaceutical Co., Ltd.
14 1Ningbo Liwah Pharmaceutical Co.,Ltd
15 1SK Chemical Co., Ltd. @ Hansung Pharmaceutical Co., Ltd. @ Hansung Pharmaceutical Co., Ltd.
16 2Zhejiang Huisong Pharmaceutical Co., Ltd
17 1Zhejiang Huisong Pharmaceutical Co., Ltd.
01 1Borak Co., Ltd.
02 1Daepyeong Co., Ltd.
03 2Dasan Pharmaceutical Co., Ltd.
04 1Dong Sung Pharmaceutical Co., Ltd.
05 1Dong-A ST Co., Ltd.
06 1Ester Corporation
07 2Hanwha Pharmaceutical Co., Ltd.
08 1Hiple Co., Ltd.
09 1Hyundai Bioland Co., Ltd.
10 3Kukjeon Pharmaceutical Co., Ltd.
11 1Otran Korea Co., Ltd.
12 1Otran Pharm Korea Co., Ltd.
13 1Parmarine Co., Ltd.
14 2Poonglim Pharmaceutical Co., Ltd.
15 1SK Chemical Co., Ltd.
01 175% ethanol extract (5:1)
02 175% ethanol extract (5→1)
03 195% ethanol extract (20→1)
04 1095% ethanol extract of mugwort leaves (20→1)
05 1Angelica root 30% ethanol tincture (1:2.5~3.5)
06 1Iberis Amara 50% Ethanol Tincture (1:1.5~2.5)
07 1Willow pea 70% ethanol dry extract (6~12→1)
08 4Wiryungseon·Gwalrugeun·Hagocho 30% ethanol dried extract (40→1)
01 11China
02 1Germany
03 1India
04 3South Korea
05 2Switzerland
06 2Blank
95% ethanol extract of mugwort leaves (20→1)
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2021-03-10
Registration Number : 20210310-9-K-64-08
Manufacturer Name : Guangdong Qingyunshan Pharma...
Manufacturer Address : No.369, Huanchengbei Road, Longxian Town, Wengyuan County, Guangdong Province, China
95% ethanol extract of mugwort leaves (20→1)
Registrant Name : Dasan Pharmaceutical Co., Ltd.
Registration Date : 2021-04-12
Registration Number : 20210310-9-K-64-08(1)
Manufacturer Name : Guangdong Qingyunshan Pharma...
Manufacturer Address : No.369, Huanchengbei Road, Longxian Town, Wengyuan Country, Guangdong Province, China
95% ethanol extract of mugwort leaves (20→1)
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2021-01-27
Registration Number : 20210127-9-K-61-07
Manufacturer Name : Zhejiang Huisong Pharmaceuti...
Manufacturer Address : FarFavour Pharmaceuticals Healthcare Industrial Park, Heping Changxing, Zhejiang, Chi...
Wiryungseon·Gwalrugeun·Hagocho 30% ethanol dried extract (40→1)
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2019-10-01
Registration Number : 20191001-8-K-49-02
Manufacturer Name : Zhejiang Huisong Pharmaceuti...
Manufacturer Address : No.168-1, Jiuheng road, Jiubao town, Hangzhou
Registrant Name : Dong-A ST Co., Ltd.
Registration Date : 2021-07-06
Registration Number : 20210706-9-K-65-09
Manufacturer Name : Hunan Jiudian Pharmaceutical...
Manufacturer Address : Hunan Liuyang Bio-pharmaceutical Industrial Park, Changsha, Hunan, 410329, PR, China
Registrant Name : Hiple Co., Ltd.
Registration Date : 2022-10-26
Registration Number : 20220517-211-J-1295(1)
Manufacturer Name : Hunan Tianlong Pharmaceutica...
Manufacturer Address : No. 228, Wangcheng Avenue, Wangcheng Economic and Technological Development Zone, Cha...
Registrant Name : Ester Corporation
Registration Date : 2022-05-17
Registration Number : 20220517-211-J-1295
Manufacturer Name : Hunan Tianlong Pharmaceutica...
Manufacturer Address : No. 228, Wangcheng Avenue, Wangcheng Econonic and Technological Development Zone, Cha...
Wiryungseon·Gwalrugeun·Hagocho 30% ethanol dried extract (40→1)
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2021-09-03
Registration Number : 20210903-8-K-66-03
Manufacturer Name : Hunan Warrant Pharmaceutical...
Manufacturer Address : Jiankang South Road No.5, Liuyang Biomedical Park, Hunan Province, China
Wiryungseon·Gwalrugeun·Hagocho 30% ethanol dried extract (40→1)
Registrant Name : Poonglim Pharmaceutical Co., Ltd.
Registration Date : 2022-09-19
Registration Number : 20220919-8-K-74-04
Manufacturer Name : Ningbo Green-Health Pharmace...
Manufacturer Address : Xiwu Town Foreign Technological Garden, Fenghua District, Ningbo, Zhejiang, China
95% ethanol extract of mugwort leaves (20→1)
Registrant Name : Parmarine Co., Ltd.
Registration Date : 2024-02-13
Registration Number : 20240213-9-K-80-10
Manufacturer Name : Jing Brand Chizhengtang Phar...
Manufacturer Address : No. 9, Shengming Road, Jinshan Street, Huangshi Economic and Technological Developmen...
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A alcohol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of alcohol, including repackagers and relabelers. The FDA regulates alcohol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. alcohol 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 alcohol supplier is an individual or a company that provides alcohol active pharmaceutical ingredient (API) or alcohol finished formulations upon request. The alcohol suppliers may include alcohol 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 alcohol Drug Master File in Korea (alcohol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of alcohol. The MFDS reviews the alcohol KDMF as part of the drug registration process and uses the information provided in the alcohol KDMF to evaluate the safety and efficacy of the drug.
After submitting a alcohol 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 alcohol API can apply through the Korea Drug Master File (KDMF).
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