01 1Cambrex Corporation
02 1Coating Place
03 1Cyalume Specialty Products
04 1Divis Laboratories
05 1Lonza Inc & Lonza America Inc
06 1Rubicon Research
07 1Solara Active Pharma Sciences
08 1Tsujimoto Chemical
01 2COATED DEXTROMETHORPHAN POLISTIREX
02 1DEXTROMETHORPHAN BASE
03 1DEXTROMETHORPHAN BASE USP
04 1DEXTROMETHORPHAN PHENOLPHTHALINATE
05 2DEXTROMETHORPHAN POLISTIREX
06 1DEXTROMETHORPHAN TANNATE
01 3India
02 1Japan
03 4U.S.A
01 4Active
02 4Inactive
01 1Complete
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22329
Submission : 2008-12-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18151
Submission : 2005-02-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23478
Submission : 2010-01-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-21
Pay. Date : 2019-07-29
DMF Number : 22469
Submission : 2009-01-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10264
Submission : 1993-05-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27347
Submission : 2013-09-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29216
Submission : 2015-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6561
Submission : 1986-08-07
Status : Inactive
Type : II
A Dextromethorphan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dextromethorphan, including repackagers and relabelers. The FDA regulates Dextromethorphan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dextromethorphan 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 Dextromethorphan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dextromethorphan supplier is an individual or a company that provides Dextromethorphan active pharmaceutical ingredient (API) or Dextromethorphan finished formulations upon request. The Dextromethorphan suppliers may include Dextromethorphan API manufacturers, exporters, distributors and traders.
click here to find a list of Dextromethorphan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dextromethorphan DMF (Drug Master File) is a document detailing the whole manufacturing process of Dextromethorphan active pharmaceutical ingredient (API) in detail. Different forms of Dextromethorphan DMFs exist exist since differing nations have different regulations, such as Dextromethorphan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dextromethorphan DMF submitted to regulatory agencies in the US is known as a USDMF. Dextromethorphan USDMF includes data on Dextromethorphan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dextromethorphan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dextromethorphan suppliers with USDMF on PharmaCompass.
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