01 1Aurobindo Pharma Limited
02 1CHANGZHOU KONY PHARMACEUTICAL CO., LTD. CN 213 105 Changzhou
03 1Charioteer
04 1Fareva
05 1RANBAXY LABORATORIES LIMITED
06 1Trifarma
01 3GANCICLOVIR
02 1GANCICLOVIR USP
03 1GANCICLOVIR USP (NON-STERILE API)
04 1GANCICLOVIR, USP
01 2China
02 2India
03 1Italy
04 1Luxembourg
01 4Active
02 2Inactive
01 3Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-07
Pay. Date : 2017-02-15
DMF Number : 31402
Submission : 2017-02-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-02
Pay. Date : 2015-08-07
DMF Number : 28973
Submission : 2015-04-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27133
Submission : 2013-05-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-30
Pay. Date : 2013-01-08
DMF Number : 15567
Submission : 2001-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16043
Submission : 2002-07-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23721
Submission : 2010-04-16
Status : Active
Type : II
A Ganciclovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ganciclovir, including repackagers and relabelers. The FDA regulates Ganciclovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ganciclovir 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ganciclovir supplier is an individual or a company that provides Ganciclovir active pharmaceutical ingredient (API) or Ganciclovir finished formulations upon request. The Ganciclovir suppliers may include Ganciclovir API manufacturers, exporters, distributors and traders.
click here to find a list of Ganciclovir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ganciclovir DMF (Drug Master File) is a document detailing the whole manufacturing process of Ganciclovir active pharmaceutical ingredient (API) in detail. Different forms of Ganciclovir DMFs exist exist since differing nations have different regulations, such as Ganciclovir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ganciclovir DMF submitted to regulatory agencies in the US is known as a USDMF. Ganciclovir USDMF includes data on Ganciclovir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ganciclovir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ganciclovir suppliers with USDMF on PharmaCompass.
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