01 1ALP Pharm
02 1Auro Peptides Limited
03 1MSN Laboratories
04 1Viatris
01 4PLECANATIDE
01 1China
02 2India
03 1U.S.A
01 4Active
01 3Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35439
Submission : 2020-12-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-14
Pay. Date : 2021-09-23
DMF Number : 36321
Submission : 2021-09-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-15
Pay. Date : 2020-08-12
DMF Number : 34049
Submission : 2019-09-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-14
Pay. Date : 2020-12-16
DMF Number : 34227
Submission : 2019-11-27
Status : Active
Type : II
A Plecanatide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Plecanatide, including repackagers and relabelers. The FDA regulates Plecanatide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Plecanatide 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 Plecanatide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Plecanatide supplier is an individual or a company that provides Plecanatide active pharmaceutical ingredient (API) or Plecanatide finished formulations upon request. The Plecanatide suppliers may include Plecanatide API manufacturers, exporters, distributors and traders.
click here to find a list of Plecanatide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Plecanatide DMF (Drug Master File) is a document detailing the whole manufacturing process of Plecanatide active pharmaceutical ingredient (API) in detail. Different forms of Plecanatide DMFs exist exist since differing nations have different regulations, such as Plecanatide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Plecanatide DMF submitted to regulatory agencies in the US is known as a USDMF. Plecanatide USDMF includes data on Plecanatide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Plecanatide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Plecanatide suppliers with USDMF on PharmaCompass.
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