01 1Dishman Carbogen Amcis Ltd.
01 1Handok Co., Ltd.
01 1Eprosartan mesylate
01 1India
Registrant Name : Handok Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20210325-209-J-911
Manufacturer Name : Dishman Carbogen Amcis Ltd.
Manufacturer Address : Survey No. 47 & 48, Paiki Sub Plot No. 1, Village: Lodariyal, Taluka: Sanand, Dist. A...
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A E1161 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of E1161, including repackagers and relabelers. The FDA regulates E1161 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. E1161 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 E1161 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A E1161 supplier is an individual or a company that provides E1161 active pharmaceutical ingredient (API) or E1161 finished formulations upon request. The E1161 suppliers may include E1161 API manufacturers, exporters, distributors and traders.
click here to find a list of E1161 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 E1161 Drug Master File in Korea (E1161 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of E1161. The MFDS reviews the E1161 KDMF as part of the drug registration process and uses the information provided in the E1161 KDMF to evaluate the safety and efficacy of the drug.
After submitting a E1161 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 E1161 API can apply through the Korea Drug Master File (KDMF).
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