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
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PharmaCompass offers a list of Teduglutide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Teduglutide manufacturer or Teduglutide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Teduglutide manufacturer or Teduglutide supplier.
PharmaCompass also assists you with knowing the Teduglutide API Price utilized in the formulation of products. Teduglutide API Price is not always fixed or binding as the Teduglutide Price is obtained through a variety of data sources. The Teduglutide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Gattex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gattex, including repackagers and relabelers. The FDA regulates Gattex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gattex 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 Gattex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gattex supplier is an individual or a company that provides Gattex active pharmaceutical ingredient (API) or Gattex finished formulations upon request. The Gattex suppliers may include Gattex API manufacturers, exporters, distributors and traders.
click here to find a list of Gattex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gattex DMF (Drug Master File) is a document detailing the whole manufacturing process of Gattex active pharmaceutical ingredient (API) in detail. Different forms of Gattex DMFs exist exist since differing nations have different regulations, such as Gattex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gattex DMF submitted to regulatory agencies in the US is known as a USDMF. Gattex USDMF includes data on Gattex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gattex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gattex suppliers with USDMF on PharmaCompass.
We have 3 companies offering Gattex
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