01 1PolyPeptide Group
01 1Switzerland
01 1Active
01 1Blank
01 1Blank
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33628
Submission : 2019-02-25
Status : Active
Type : II
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.
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