01 1Ash Stevens
01 1PREPARATION OF N-(2-PYRAZINECARBONYL)-L-PHENYLALANINE-L-LEUCINE BORONIC ACID BULK DRUG SUBSTANCE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13142
Submission : 1998-08-18
Status : Inactive
Type : II
A Isobutaneboronic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isobutaneboronic Acid, including repackagers and relabelers. The FDA regulates Isobutaneboronic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isobutaneboronic Acid 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 Isobutaneboronic Acid supplier is an individual or a company that provides Isobutaneboronic Acid active pharmaceutical ingredient (API) or Isobutaneboronic Acid finished formulations upon request. The Isobutaneboronic Acid suppliers may include Isobutaneboronic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Isobutaneboronic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isobutaneboronic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Isobutaneboronic Acid active pharmaceutical ingredient (API) in detail. Different forms of Isobutaneboronic Acid DMFs exist exist since differing nations have different regulations, such as Isobutaneboronic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isobutaneboronic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Isobutaneboronic Acid USDMF includes data on Isobutaneboronic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isobutaneboronic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isobutaneboronic Acid suppliers with USDMF on PharmaCompass.
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