01 1Recordati Industria Chimica e Farmaceutica SpA
01 1Sangjin Trading Co., Ltd.
01 1Dopamine hydrochloride
01 1U.S.A
Registrant Name : Sangjin Trading Co., Ltd.
Registration Date : 2021-07-22
Registration Number : 20210722-210-J-1077
Manufacturer Name : Recordati Industria Chimica ...
Manufacturer Address : Via Mediana Cisterna, 4- 04011 Aprilia (LT) - Italy
60
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A ASL 279 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ASL 279, including repackagers and relabelers. The FDA regulates ASL 279 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ASL 279 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 ASL 279 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A ASL 279 supplier is an individual or a company that provides ASL 279 active pharmaceutical ingredient (API) or ASL 279 finished formulations upon request. The ASL 279 suppliers may include ASL 279 API manufacturers, exporters, distributors and traders.
click here to find a list of ASL 279 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 ASL 279 Drug Master File in Korea (ASL 279 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ASL 279. The MFDS reviews the ASL 279 KDMF as part of the drug registration process and uses the information provided in the ASL 279 KDMF to evaluate the safety and efficacy of the drug.
After submitting a ASL 279 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 ASL 279 API can apply through the Korea Drug Master File (KDMF).
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