Veranova: A CDMO that manages complexity with confidence.
01 1Veranova
02 13M Drug Delivery Systems
03 1Abbott Laboratories
04 1Boehringer Ingelheim GmbH
05 1Cambrex Corporation
06 1Chattem Chemicals, Inc
07 1Cody Laboratories, Inc.
08 1Curia
09 2Cygnus Inc
10 2Mallinckrodt Pharmaceuticals
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-18
Pay. Date : 2012-12-13
DMF Number : 6217
Submission : 1986-02-25
Status :
Type : II
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A Duragesic manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Duragesic, including repackagers and relabelers. The FDA regulates Duragesic manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Duragesic 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 Duragesic supplier is an individual or a company that provides Duragesic active pharmaceutical ingredient (API) or Duragesic finished formulations upon request. The Duragesic suppliers may include Duragesic API manufacturers, exporters, distributors and traders.
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A Duragesic DMF (Drug Master File) is a document detailing the whole manufacturing process of Duragesic active pharmaceutical ingredient (API) in detail. Different forms of Duragesic DMFs exist exist since differing nations have different regulations, such as Duragesic USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Duragesic DMF submitted to regulatory agencies in the US is known as a USDMF. Duragesic USDMF includes data on Duragesic's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Duragesic USDMF is kept confidential to protect the manufacturer’s intellectual property.
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