01 1Dongbang FTL Co., Ltd.
01 1Dongbang FTL Co., Ltd.
01 1Mepenam Mountain
01 1South Korea
Registrant Name : Dongbang FTL Co., Ltd.
Registration Date : 2019-02-22
Registration Number : 20190222-211-J-312
Manufacturer Name : Dongbang FTL Co., Ltd.
Manufacturer Address : 78, Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
82
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A Ponstel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ponstel, including repackagers and relabelers. The FDA regulates Ponstel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ponstel 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 Ponstel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ponstel supplier is an individual or a company that provides Ponstel active pharmaceutical ingredient (API) or Ponstel finished formulations upon request. The Ponstel suppliers may include Ponstel API manufacturers, exporters, distributors and traders.
click here to find a list of Ponstel suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Ponstel Drug Master File in Korea (Ponstel KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ponstel. The MFDS reviews the Ponstel KDMF as part of the drug registration process and uses the information provided in the Ponstel KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ponstel 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 Ponstel API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ponstel suppliers with KDMF on PharmaCompass.
