01 1ALP Pharm
02 1AmbioPharm
03 1MSN Laboratories
01 2TEDUGLUTIDE
02 1TEDUGLUTIDE NON-STERILE
01 1China
02 1India
03 1U.S.A
01 3Active
01 2Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35438
Submission : 2020-12-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-11-04
Pay. Date : 2016-08-01
DMF Number : 30583
Submission : 2016-08-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-30
Pay. Date : 2023-05-23
DMF Number : 37596
Submission : 2022-12-15
Status : Active
Type : II
A Teduglutide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Teduglutide, including repackagers and relabelers. The FDA regulates Teduglutide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Teduglutide 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 Teduglutide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Teduglutide supplier is an individual or a company that provides Teduglutide active pharmaceutical ingredient (API) or Teduglutide finished formulations upon request. The Teduglutide suppliers may include Teduglutide API manufacturers, exporters, distributors and traders.
click here to find a list of Teduglutide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Teduglutide DMF (Drug Master File) is a document detailing the whole manufacturing process of Teduglutide active pharmaceutical ingredient (API) in detail. Different forms of Teduglutide DMFs exist exist since differing nations have different regulations, such as Teduglutide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Teduglutide DMF submitted to regulatory agencies in the US is known as a USDMF. Teduglutide USDMF includes data on Teduglutide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Teduglutide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Teduglutide suppliers with USDMF on PharmaCompass.
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