01 1Dipharma Francis Srl
01 1Masung LS Co., Ltd.
01 1Selegiline hydrochloride
01 1Italy
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2021-08-19
Registration Number : 20210819-209-J-950
Manufacturer Name : Dipharma Francis Srl
Manufacturer Address : Via Bissone 5 20021 Baranzate (MI), Italy
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A Otrasel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Otrasel, including repackagers and relabelers. The FDA regulates Otrasel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Otrasel 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 Otrasel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Otrasel supplier is an individual or a company that provides Otrasel active pharmaceutical ingredient (API) or Otrasel finished formulations upon request. The Otrasel suppliers may include Otrasel API manufacturers, exporters, distributors and traders.
click here to find a list of Otrasel 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 Otrasel Drug Master File in Korea (Otrasel KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Otrasel. The MFDS reviews the Otrasel KDMF as part of the drug registration process and uses the information provided in the Otrasel KDMF to evaluate the safety and efficacy of the drug.
After submitting a Otrasel 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 Otrasel API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Otrasel suppliers with KDMF on PharmaCompass.
