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