01 1Biovectra Inc
01 1ZERANOL
01 1Canada
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22441
Submission : 2009-01-21
Status : Inactive
Type : II
A Zeranol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zeranol, including repackagers and relabelers. The FDA regulates Zeranol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zeranol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Zeranol supplier is an individual or a company that provides Zeranol active pharmaceutical ingredient (API) or Zeranol finished formulations upon request. The Zeranol suppliers may include Zeranol API manufacturers, exporters, distributors and traders.
click here to find a list of Zeranol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zeranol DMF (Drug Master File) is a document detailing the whole manufacturing process of Zeranol active pharmaceutical ingredient (API) in detail. Different forms of Zeranol DMFs exist exist since differing nations have different regulations, such as Zeranol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zeranol DMF submitted to regulatory agencies in the US is known as a USDMF. Zeranol USDMF includes data on Zeranol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zeranol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zeranol suppliers with USDMF on PharmaCompass.
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