01 1Astellas Pharma
01 1FK962
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17168
Submission : 2004-02-19
Status : Inactive
Type : II
A Fk962 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fk962, including repackagers and relabelers. The FDA regulates Fk962 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fk962 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 Fk962 supplier is an individual or a company that provides Fk962 active pharmaceutical ingredient (API) or Fk962 finished formulations upon request. The Fk962 suppliers may include Fk962 API manufacturers, exporters, distributors and traders.
click here to find a list of Fk962 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fk962 DMF (Drug Master File) is a document detailing the whole manufacturing process of Fk962 active pharmaceutical ingredient (API) in detail. Different forms of Fk962 DMFs exist exist since differing nations have different regulations, such as Fk962 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fk962 DMF submitted to regulatory agencies in the US is known as a USDMF. Fk962 USDMF includes data on Fk962's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fk962 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fk962 suppliers with USDMF on PharmaCompass.
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