01 1Siegfried AG
02 2Xellia Pharmaceuticals ApS
01 2GRAMICIDIN
02 1GRAMICIDIN, USP
01 2Denmark
02 1Switzerland
01 1Active
02 2Inactive
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 201
Submission : 1940-01-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-27
Pay. Date : 2012-11-15
DMF Number : 17538
Submission : 2004-07-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13494
Submission : 1998-09-01
Status : Inactive
Type : II
A Gramicidin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gramicidin, including repackagers and relabelers. The FDA regulates Gramicidin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gramicidin 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 Gramicidin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gramicidin supplier is an individual or a company that provides Gramicidin active pharmaceutical ingredient (API) or Gramicidin finished formulations upon request. The Gramicidin suppliers may include Gramicidin API manufacturers, exporters, distributors and traders.
click here to find a list of Gramicidin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gramicidin DMF (Drug Master File) is a document detailing the whole manufacturing process of Gramicidin active pharmaceutical ingredient (API) in detail. Different forms of Gramicidin DMFs exist exist since differing nations have different regulations, such as Gramicidin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gramicidin DMF submitted to regulatory agencies in the US is known as a USDMF. Gramicidin USDMF includes data on Gramicidin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gramicidin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gramicidin suppliers with USDMF on PharmaCompass.
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