01 1PolyPeptide Group
01 1TERTOMOTIDE DRUG SUBSTANCE
01 1Switzerland
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33628
Submission : 2019-02-25
Status : Active
Type : II
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.
A Tertomotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Tertomotide active pharmaceutical ingredient (API) in detail. Different forms of Tertomotide DMFs exist exist since differing nations have different regulations, such as Tertomotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tertomotide DMF submitted to regulatory agencies in the US is known as a USDMF. Tertomotide USDMF includes data on Tertomotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tertomotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tertomotide suppliers with USDMF on PharmaCompass.
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