01 1Regis Technologies
01 1CLORGYLINE (REGIS CODE NO. 002061)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5502
Submission : 1984-08-01
Status : Inactive
Type : II
A Clorgyline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clorgyline, including repackagers and relabelers. The FDA regulates Clorgyline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clorgyline 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 Clorgyline supplier is an individual or a company that provides Clorgyline active pharmaceutical ingredient (API) or Clorgyline finished formulations upon request. The Clorgyline suppliers may include Clorgyline API manufacturers, exporters, distributors and traders.
click here to find a list of Clorgyline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Clorgyline DMF (Drug Master File) is a document detailing the whole manufacturing process of Clorgyline active pharmaceutical ingredient (API) in detail. Different forms of Clorgyline DMFs exist exist since differing nations have different regulations, such as Clorgyline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clorgyline DMF submitted to regulatory agencies in the US is known as a USDMF. Clorgyline USDMF includes data on Clorgyline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clorgyline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clorgyline suppliers with USDMF on PharmaCompass.
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