01 1Abbott Laboratories
01 1PENTIGETIDE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7812
Submission : 1988-12-09
Status : Inactive
Type : II
A Pentigide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentigide, including repackagers and relabelers. The FDA regulates Pentigide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentigide 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 Pentigide supplier is an individual or a company that provides Pentigide active pharmaceutical ingredient (API) or Pentigide finished formulations upon request. The Pentigide suppliers may include Pentigide API manufacturers, exporters, distributors and traders.
click here to find a list of Pentigide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pentigide DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentigide active pharmaceutical ingredient (API) in detail. Different forms of Pentigide DMFs exist exist since differing nations have different regulations, such as Pentigide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pentigide DMF submitted to regulatory agencies in the US is known as a USDMF. Pentigide USDMF includes data on Pentigide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentigide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pentigide suppliers with USDMF on PharmaCompass.
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