01 1Eastman Chemical Company
01 1BIOSUSTANE® SAIB (SUCROSE ACETATE ISOBUTYRATE)
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19694
Submission : 2007-08-31
Status : Active
Type : IV
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PharmaCompass offers a list of Sucrose Acetate Isobutyrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sucrose Acetate Isobutyrate manufacturer or Sucrose Acetate Isobutyrate supplier for your needs.
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A Sucrose Acetate Isobutyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sucrose Acetate Isobutyrate, including repackagers and relabelers. The FDA regulates Sucrose Acetate Isobutyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sucrose Acetate Isobutyrate 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 Sucrose Acetate Isobutyrate supplier is an individual or a company that provides Sucrose Acetate Isobutyrate active pharmaceutical ingredient (API) or Sucrose Acetate Isobutyrate finished formulations upon request. The Sucrose Acetate Isobutyrate suppliers may include Sucrose Acetate Isobutyrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sucrose Acetate Isobutyrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sucrose Acetate Isobutyrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sucrose Acetate Isobutyrate active pharmaceutical ingredient (API) in detail. Different forms of Sucrose Acetate Isobutyrate DMFs exist exist since differing nations have different regulations, such as Sucrose Acetate Isobutyrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sucrose Acetate Isobutyrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sucrose Acetate Isobutyrate USDMF includes data on Sucrose Acetate Isobutyrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sucrose Acetate Isobutyrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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