01 1PolyPeptide SA
01 1Samsung Pharmaceutical Co., Ltd.
01 1Tertomotide hydrochloride
01 1Switzerland
Registrant Name : Samsung Pharmaceutical Co., Ltd.
Registration Date : 2015-02-26
Registration Number : No. 2617-1-ND(1)-A
Manufacturer Name : PolyPeptide SA
Manufacturer Address : Chaussee de Tubize 297, Braine-l'Alleud, 1420 Belgium
A Tertomotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tertomotide, including repackagers and relabelers. The FDA regulates Tertomotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tertomotide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Tertomotide supplier is an individual or a company that provides Tertomotide active pharmaceutical ingredient (API) or Tertomotide finished formulations upon request. The Tertomotide suppliers may include Tertomotide API manufacturers, exporters, distributors and traders.
click here to find a list of Tertomotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 Tertomotide Drug Master File in Korea (Tertomotide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tertomotide. The MFDS reviews the Tertomotide KDMF as part of the drug registration process and uses the information provided in the Tertomotide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tertomotide 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 Tertomotide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tertomotide suppliers with KDMF on PharmaCompass.
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