01 1Dipharma Francis Srl
01 1Toru Co., Ltd.
01 1nortriptyline hydrochloride
01 1Italy
Registrant Name : Toru Co., Ltd.
Registration Date : 2024-11-12
Registration Number : 20241112-209-J-1722
Manufacturer Name : Dipharma Francis Srl
Manufacturer Address : Via Bissone, 5, 20021, Baranzate (MI), Italy
29
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A 00FN6IH15D manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 00FN6IH15D, including repackagers and relabelers. The FDA regulates 00FN6IH15D manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 00FN6IH15D 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 00FN6IH15D supplier is an individual or a company that provides 00FN6IH15D active pharmaceutical ingredient (API) or 00FN6IH15D finished formulations upon request. The 00FN6IH15D suppliers may include 00FN6IH15D 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 00FN6IH15D Drug Master File in Korea (00FN6IH15D KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 00FN6IH15D. The MFDS reviews the 00FN6IH15D KDMF as part of the drug registration process and uses the information provided in the 00FN6IH15D KDMF to evaluate the safety and efficacy of the drug.
After submitting a 00FN6IH15D 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 00FN6IH15D API can apply through the Korea Drug Master File (KDMF).
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