01 1Hybio Pharmaceutical
02 1Mallinckrodt Pharmaceuticals
01 1BRAIN NATRIURETIC PEPTIDE
02 1NESIRITIDE CITRATE, NON-STERILE BULK DRUG SUBSTANCE
01 1China
02 1Ireland
01 1Active
02 1Inactive
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-07
Pay. Date : 2014-04-10
DMF Number : 27265
Submission : 2013-06-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10543
Submission : 1993-10-26
Status : Inactive
Type : II
A Natriuretic Peptide, Brain manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Natriuretic Peptide, Brain, including repackagers and relabelers. The FDA regulates Natriuretic Peptide, Brain manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Natriuretic Peptide, Brain 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 Natriuretic Peptide, Brain manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Natriuretic Peptide, Brain supplier is an individual or a company that provides Natriuretic Peptide, Brain active pharmaceutical ingredient (API) or Natriuretic Peptide, Brain finished formulations upon request. The Natriuretic Peptide, Brain suppliers may include Natriuretic Peptide, Brain API manufacturers, exporters, distributors and traders.
click here to find a list of Natriuretic Peptide, Brain suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Natriuretic Peptide, Brain DMF (Drug Master File) is a document detailing the whole manufacturing process of Natriuretic Peptide, Brain active pharmaceutical ingredient (API) in detail. Different forms of Natriuretic Peptide, Brain DMFs exist exist since differing nations have different regulations, such as Natriuretic Peptide, Brain USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Natriuretic Peptide, Brain DMF submitted to regulatory agencies in the US is known as a USDMF. Natriuretic Peptide, Brain USDMF includes data on Natriuretic Peptide, Brain's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Natriuretic Peptide, Brain USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Natriuretic Peptide, Brain suppliers with USDMF on PharmaCompass.
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