01 1INDUSTRIALE CHIMICA srl
01 1Hiple Co., Ltd.
01 1phentolamine mesylate
01 1Italy
Registrant Name : Hiple Co., Ltd.
Registration Date : 2025-03-20
Registration Number : 20250320-210-J-1790
Manufacturer Name : INDUSTRIALE CHIMICA srl
Manufacturer Address : Via EH Grieg, 13 21047 SARONNO (VARESE), ITALY
83
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A Regityn manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Regityn, including repackagers and relabelers. The FDA regulates Regityn manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Regityn 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 Regityn supplier is an individual or a company that provides Regityn active pharmaceutical ingredient (API) or Regityn finished formulations upon request. The Regityn suppliers may include Regityn 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 Regityn Drug Master File in Korea (Regityn KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Regityn. The MFDS reviews the Regityn KDMF as part of the drug registration process and uses the information provided in the Regityn KDMF to evaluate the safety and efficacy of the drug.
After submitting a Regityn 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 Regityn API can apply through the Korea Drug Master File (KDMF).
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