01 1Fareva
02 1Hainan Poly Pharm
01 2GANCICLOVIR SODIUM
01 1China
02 1Luxembourg
01 1Active
02 1Inactive
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-05
Pay. Date : 2013-09-26
DMF Number : 16992
Submission : 2003-11-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25122
Submission : 2011-07-13
Status : Inactive
Type : II
A Ganciclovir Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ganciclovir Sodium, including repackagers and relabelers. The FDA regulates Ganciclovir Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ganciclovir Sodium 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 Ganciclovir Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ganciclovir Sodium supplier is an individual or a company that provides Ganciclovir Sodium active pharmaceutical ingredient (API) or Ganciclovir Sodium finished formulations upon request. The Ganciclovir Sodium suppliers may include Ganciclovir Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Ganciclovir Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ganciclovir Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Ganciclovir Sodium active pharmaceutical ingredient (API) in detail. Different forms of Ganciclovir Sodium DMFs exist exist since differing nations have different regulations, such as Ganciclovir Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ganciclovir Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Ganciclovir Sodium USDMF includes data on Ganciclovir Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ganciclovir Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ganciclovir Sodium suppliers with USDMF on PharmaCompass.
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