01 1MSN Laboratories
01 1CERITINIB
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32553
Submission : 2018-03-26
Status : Active
Type : II
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A Zykadia manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zykadia, including repackagers and relabelers. The FDA regulates Zykadia manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zykadia 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 Zykadia manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Zykadia supplier is an individual or a company that provides Zykadia active pharmaceutical ingredient (API) or Zykadia finished formulations upon request. The Zykadia suppliers may include Zykadia API manufacturers, exporters, distributors and traders.
click here to find a list of Zykadia suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Zykadia DMF (Drug Master File) is a document detailing the whole manufacturing process of Zykadia active pharmaceutical ingredient (API) in detail. Different forms of Zykadia DMFs exist exist since differing nations have different regulations, such as Zykadia USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zykadia DMF submitted to regulatory agencies in the US is known as a USDMF. Zykadia USDMF includes data on Zykadia's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zykadia USDMF is kept confidential to protect the manufacturer’s intellectual property.
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