Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
01 1Noramco
02 1CHONGQING LAND TOWER PHARMACEUTICAL CO
03 1Curia
04 3Mallinckrodt Pharmaceuticals
01 3METHYLNALTREXONE BROMIDE
02 1METHYLNALTREXONE BROMIDE, CODE 1251
03 2NALTREXONE METHOBROMIDE
01 1China
02 3Ireland
03 2U.S.A
01 4Active
02 2Inactive
01 2Complete
02 4Blank
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26528
Submission : 2012-09-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30173
Submission : 2016-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-06-05
Pay. Date : 2020-03-05
DMF Number : 31803
Submission : 2020-03-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-08
Pay. Date : 2014-07-28
DMF Number : 22553
Submission : 2009-02-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15837
Submission : 2002-01-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8948
Submission : 1991-01-24
Status : Inactive
Type : II
A Methylnaltrexone Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methylnaltrexone Bromide, including repackagers and relabelers. The FDA regulates Methylnaltrexone Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methylnaltrexone Bromide 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 Methylnaltrexone Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methylnaltrexone Bromide supplier is an individual or a company that provides Methylnaltrexone Bromide active pharmaceutical ingredient (API) or Methylnaltrexone Bromide finished formulations upon request. The Methylnaltrexone Bromide suppliers may include Methylnaltrexone Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Methylnaltrexone Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methylnaltrexone Bromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Methylnaltrexone Bromide active pharmaceutical ingredient (API) in detail. Different forms of Methylnaltrexone Bromide DMFs exist exist since differing nations have different regulations, such as Methylnaltrexone Bromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methylnaltrexone Bromide DMF submitted to regulatory agencies in the US is known as a USDMF. Methylnaltrexone Bromide USDMF includes data on Methylnaltrexone Bromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methylnaltrexone Bromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methylnaltrexone Bromide suppliers with USDMF on PharmaCompass.
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