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