01 1BCN Peptides
01 1NESIRITIDE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-19
Pay. Date : 2013-01-11
DMF Number : 26676
Submission : 2012-12-04
Status : Active
Type : II
A Natrecor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Natrecor, including repackagers and relabelers. The FDA regulates Natrecor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Natrecor API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Natrecor supplier is an individual or a company that provides Natrecor active pharmaceutical ingredient (API) or Natrecor finished formulations upon request. The Natrecor suppliers may include Natrecor API manufacturers, exporters, distributors and traders.
click here to find a list of Natrecor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Natrecor DMF (Drug Master File) is a document detailing the whole manufacturing process of Natrecor active pharmaceutical ingredient (API) in detail. Different forms of Natrecor DMFs exist exist since differing nations have different regulations, such as Natrecor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Natrecor DMF submitted to regulatory agencies in the US is known as a USDMF. Natrecor USDMF includes data on Natrecor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Natrecor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Natrecor suppliers with USDMF on PharmaCompass.
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