Veranova: A CDMO that manages complexity with confidence.
01 1Veranova
02 1Abbott Laboratories
03 2Cambrex Corporation
04 1Chattem Chemicals, Inc
05 1Cody Laboratories, Inc.
06 1Curia
07 1Fujifilm Diosynth Biotechnologies
08 2Mallinckrodt Pharmaceuticals
09 1Merck & Co
10 1Yichang Humanwell Pharmaceutical
11 1Blank
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5038
Submission : 1983-08-15
Status :
Type : II
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A D01399 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D01399, including repackagers and relabelers. The FDA regulates D01399 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D01399 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A D01399 supplier is an individual or a company that provides D01399 active pharmaceutical ingredient (API) or D01399 finished formulations upon request. The D01399 suppliers may include D01399 API manufacturers, exporters, distributors and traders.
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A D01399 DMF (Drug Master File) is a document detailing the whole manufacturing process of D01399 active pharmaceutical ingredient (API) in detail. Different forms of D01399 DMFs exist exist since differing nations have different regulations, such as D01399 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A D01399 DMF submitted to regulatory agencies in the US is known as a USDMF. D01399 USDMF includes data on D01399's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The D01399 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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