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 Subsys manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Subsys, including repackagers and relabelers. The FDA regulates Subsys manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Subsys 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 Subsys supplier is an individual or a company that provides Subsys active pharmaceutical ingredient (API) or Subsys finished formulations upon request. The Subsys suppliers may include Subsys API manufacturers, exporters, distributors and traders.
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A Subsys DMF (Drug Master File) is a document detailing the whole manufacturing process of Subsys active pharmaceutical ingredient (API) in detail. Different forms of Subsys DMFs exist exist since differing nations have different regulations, such as Subsys USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Subsys DMF submitted to regulatory agencies in the US is known as a USDMF. Subsys USDMF includes data on Subsys's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Subsys USDMF is kept confidential to protect the manufacturer’s intellectual property.
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