01 1Hybio Pharmaceutical
02 1Jin Dun Medical
03 1Mallinckrodt Pharmaceuticals
01 2China
02 1Ireland
01 1Active
02 1Inactive
03 1Blank
01 3Blank
01 3Blank
01 3Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-07
Pay. Date : 2014-04-10
DMF Number : 27265
Submission : 2013-06-25
Status : Active
Type : II
NDC Package Code : 14403-0006
Start Marketing Date : 2014-06-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10543
Submission : 1993-10-26
Status : Inactive
Type : II
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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.
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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.
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