01 1Peninsula Laboratories
02 3PolyPeptide Group
03 1Blank
01 1HUMAN SECRETIN ACETATE DRUG SUBSTANCE
02 1PORCINE SECRETIN, ACETATE
03 1SECRETIN (PORCINE)
04 1SECRETIN DRUG SUBSTANCE
05 1SECRETIN PENTAHYDROCHLORIDE, BULK FORM
01 3Switzerland
02 1U.S.A
03 1Blank
01 2Active
02 3Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9299
Submission : 1991-08-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24451
Submission : 2010-12-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15402
Submission : 2001-04-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15654
Submission : 2001-10-05
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4637
Submission : 1982-08-13
Status : Inactive
Type : II
Portfolio PDF
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Website
Corporate PDF
A Secretin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Secretin, including repackagers and relabelers. The FDA regulates Secretin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Secretin 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 Secretin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Secretin supplier is an individual or a company that provides Secretin active pharmaceutical ingredient (API) or Secretin finished formulations upon request. The Secretin suppliers may include Secretin API manufacturers, exporters, distributors and traders.
click here to find a list of Secretin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Secretin DMF (Drug Master File) is a document detailing the whole manufacturing process of Secretin active pharmaceutical ingredient (API) in detail. Different forms of Secretin DMFs exist exist since differing nations have different regulations, such as Secretin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Secretin DMF submitted to regulatory agencies in the US is known as a USDMF. Secretin USDMF includes data on Secretin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Secretin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Secretin suppliers with USDMF on PharmaCompass.
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