01 1Raschig GmbH
01 1EMORFAZONE, CLINICAL AND PRE-CLINICAL STUDIES
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9156
Submission : 1991-06-07
Status : Inactive
Type : II
16
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A APADH manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of APADH, including repackagers and relabelers. The FDA regulates APADH manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. APADH 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 APADH supplier is an individual or a company that provides APADH active pharmaceutical ingredient (API) or APADH finished formulations upon request. The APADH suppliers may include APADH API manufacturers, exporters, distributors and traders.
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A APADH DMF (Drug Master File) is a document detailing the whole manufacturing process of APADH active pharmaceutical ingredient (API) in detail. Different forms of APADH DMFs exist exist since differing nations have different regulations, such as APADH USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A APADH DMF submitted to regulatory agencies in the US is known as a USDMF. APADH USDMF includes data on APADH's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The APADH USDMF is kept confidential to protect the manufacturer’s intellectual property.
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