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
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PharmaCompass offers a list of Natriuretic Peptide, Brain API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Natriuretic Peptide, Brain manufacturer or Natriuretic Peptide, Brain supplier for your needs.
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PharmaCompass also assists you with knowing the Natriuretic Peptide, Brain API Price utilized in the formulation of products. Natriuretic Peptide, Brain API Price is not always fixed or binding as the Natriuretic Peptide, Brain Price is obtained through a variety of data sources. The Natriuretic Peptide, Brain Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nesiritide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nesiritide, including repackagers and relabelers. The FDA regulates Nesiritide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nesiritide 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 Nesiritide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nesiritide supplier is an individual or a company that provides Nesiritide active pharmaceutical ingredient (API) or Nesiritide finished formulations upon request. The Nesiritide suppliers may include Nesiritide API manufacturers, exporters, distributors and traders.
click here to find a list of Nesiritide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nesiritide DMF (Drug Master File) is a document detailing the whole manufacturing process of Nesiritide active pharmaceutical ingredient (API) in detail. Different forms of Nesiritide DMFs exist exist since differing nations have different regulations, such as Nesiritide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nesiritide DMF submitted to regulatory agencies in the US is known as a USDMF. Nesiritide USDMF includes data on Nesiritide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nesiritide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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