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