01 1Procos SPA
01 1Sungjin Exim Co., Ltd.
01 1Pyridostigmine bromide
01 1Italy
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-05-12
Registration Number : 20210512-211-J-632
Manufacturer Name : Procos SPA
Manufacturer Address : Viamatteotti 249, Cameri(Novara)28062 Italy
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A Kalimin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Kalimin, including repackagers and relabelers. The FDA regulates Kalimin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Kalimin 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 Kalimin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Kalimin supplier is an individual or a company that provides Kalimin active pharmaceutical ingredient (API) or Kalimin finished formulations upon request. The Kalimin suppliers may include Kalimin API manufacturers, exporters, distributors and traders.
click here to find a list of Kalimin 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 Kalimin Drug Master File in Korea (Kalimin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Kalimin. The MFDS reviews the Kalimin KDMF as part of the drug registration process and uses the information provided in the Kalimin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Kalimin 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 Kalimin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Kalimin suppliers with KDMF on PharmaCompass.
