01 1Shiratori Pharmaceutical Co., Ltd.@Nipro Pharma Corporation
01 1Kolon Pharmaceutical Co., Ltd.
01 1Emedastine fumarate sustained release granules
01 1Japan
Emedastine fumarate sustained release granules
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2022-02-08
Registration Number : 20220208-209-J-1230
Manufacturer Name : Shiratori Pharmaceutical Co....
Manufacturer Address : 54 Shinminato, Mihama-ku, Chiba-shi, Chiba, Japan@2-1, Minamisakae-cho, Kasukabe-shi,...
A Emedastine Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Emedastine Fumarate, including repackagers and relabelers. The FDA regulates Emedastine Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Emedastine Fumarate 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 Emedastine Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Emedastine Fumarate supplier is an individual or a company that provides Emedastine Fumarate active pharmaceutical ingredient (API) or Emedastine Fumarate finished formulations upon request. The Emedastine Fumarate suppliers may include Emedastine Fumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Emedastine Fumarate 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 Emedastine Fumarate Drug Master File in Korea (Emedastine Fumarate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Emedastine Fumarate. The MFDS reviews the Emedastine Fumarate KDMF as part of the drug registration process and uses the information provided in the Emedastine Fumarate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Emedastine Fumarate 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 Emedastine Fumarate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Emedastine Fumarate suppliers with KDMF on PharmaCompass.
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