01 1Daepyeong Co., Ltd.
02 1Hyundai Bioland Co., Ltd.
01 1Daepyeong Co., Ltd.
02 1Hyundai Bioland Co., Ltd.
01 2Hyunho-saek·Gyeonwooja (5:1) 50% ethanol soft extract (9.5~11.5→1)
01 2South Korea
Hyunho-saek·Gyeonwooja (5:1) 50% ethanol soft extract (9.5~11.5→1)
Registrant Name : Daepyeong Co., Ltd.
Registration Date : 2017-12-19
Registration Number : 20171219-13-K-18-01
Manufacturer Name : Daepyeong Co., Ltd.
Manufacturer Address : 19-8 Yeongdong-gil, Hamchang-eup, Sangju-si, Gyeongbuk
Hyunho-saek·Gyeonwooja (5:1) 50% ethanol soft extract (9.5~11.5→1)
Registrant Name : Hyundai Bioland Co., Ltd.
Registration Date : 2018-09-11
Registration Number : 20180911-13-K-41-02
Manufacturer Name : Hyundai Bioland Co., Ltd.
Manufacturer Address : 22 Osong Life 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do
A Rotundine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rotundine, including repackagers and relabelers. The FDA regulates Rotundine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rotundine 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 Rotundine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rotundine supplier is an individual or a company that provides Rotundine active pharmaceutical ingredient (API) or Rotundine finished formulations upon request. The Rotundine suppliers may include Rotundine API manufacturers, exporters, distributors and traders.
click here to find a list of Rotundine 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 Rotundine Drug Master File in Korea (Rotundine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rotundine. The MFDS reviews the Rotundine KDMF as part of the drug registration process and uses the information provided in the Rotundine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rotundine 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 Rotundine API can apply through the Korea Drug Master File (KDMF).
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