01 1Lunan Pharmaceutical
01 1GIMERACIL
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35064
Submission : 2021-05-31
Status : Active
Type : II
A Gimeracil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gimeracil, including repackagers and relabelers. The FDA regulates Gimeracil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gimeracil 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 Gimeracil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gimeracil supplier is an individual or a company that provides Gimeracil active pharmaceutical ingredient (API) or Gimeracil finished formulations upon request. The Gimeracil suppliers may include Gimeracil API manufacturers, exporters, distributors and traders.
click here to find a list of Gimeracil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gimeracil DMF (Drug Master File) is a document detailing the whole manufacturing process of Gimeracil active pharmaceutical ingredient (API) in detail. Different forms of Gimeracil DMFs exist exist since differing nations have different regulations, such as Gimeracil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gimeracil DMF submitted to regulatory agencies in the US is known as a USDMF. Gimeracil USDMF includes data on Gimeracil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gimeracil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gimeracil suppliers with USDMF on PharmaCompass.
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