01 1Recordati Industria Chimica e Farmaceutica SpA
01 1Jeil Pharmaceutical Co., Ltd.
01 1Flavoxate hydrochloride
01 1U.S.A
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2021-07-14
Registration Number : 20210714-209-J-1070
Manufacturer Name : Recordati Industria Chimica ...
Manufacturer Address : Via Mediana Cisterna, 4 - 04011 Aprilia (LT), Italy
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A 27814-EP2314587A1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 27814-EP2314587A1, including repackagers and relabelers. The FDA regulates 27814-EP2314587A1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 27814-EP2314587A1 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 27814-EP2314587A1 supplier is an individual or a company that provides 27814-EP2314587A1 active pharmaceutical ingredient (API) or 27814-EP2314587A1 finished formulations upon request. The 27814-EP2314587A1 suppliers may include 27814-EP2314587A1 API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 27814-EP2314587A1 Drug Master File in Korea (27814-EP2314587A1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 27814-EP2314587A1. The MFDS reviews the 27814-EP2314587A1 KDMF as part of the drug registration process and uses the information provided in the 27814-EP2314587A1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a 27814-EP2314587A1 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 27814-EP2314587A1 API can apply through the Korea Drug Master File (KDMF).
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