01 1Hana Pharmaceutical Co., Ltd. @ Dongbang FTL Co., Ltd. (Starting material manufacturer)
01 1Hana Pharmaceutical Co., Ltd.
01 1diclofenac potassium
01 1South Korea
Registrant Name : Hana Pharmaceutical Co., Ltd.
Registration Date : 2013-06-14
Registration Number : 20130614-80-D-128-18
Manufacturer Name : Hana Pharmaceutical Co., Ltd...
Manufacturer Address : 133, Jeyakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do @ 78, Jeyakgongdan 4-...
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A Zipsor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zipsor, including repackagers and relabelers. The FDA regulates Zipsor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zipsor 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 Zipsor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Zipsor supplier is an individual or a company that provides Zipsor active pharmaceutical ingredient (API) or Zipsor finished formulations upon request. The Zipsor suppliers may include Zipsor API manufacturers, exporters, distributors and traders.
click here to find a list of Zipsor 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 Zipsor Drug Master File in Korea (Zipsor KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zipsor. The MFDS reviews the Zipsor KDMF as part of the drug registration process and uses the information provided in the Zipsor KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zipsor 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 Zipsor API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zipsor suppliers with KDMF on PharmaCompass.
