01 1Recordati Industria Chimica e Farmaceutica SpA
01 1Jeil Pharmaceutical Co., Ltd.
01 1Flaboxate 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 Urispas manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urispas, including repackagers and relabelers. The FDA regulates Urispas manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urispas 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 Urispas manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Urispas supplier is an individual or a company that provides Urispas active pharmaceutical ingredient (API) or Urispas finished formulations upon request. The Urispas suppliers may include Urispas API manufacturers, exporters, distributors and traders.
click here to find a list of Urispas 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 Urispas Drug Master File in Korea (Urispas KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Urispas. The MFDS reviews the Urispas KDMF as part of the drug registration process and uses the information provided in the Urispas KDMF to evaluate the safety and efficacy of the drug.
After submitting a Urispas 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 Urispas API can apply through the Korea Drug Master File (KDMF).
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