01 1Aurobindo Pharma Limited
02 1Sandoz B2B
01 1NAFCILLIN ACID
02 1NAFCILLIN FOR INJECTION USP (STERILE) BULK
01 1India
02 1Switzerland
01 1Active
02 1Inactive
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-10
Pay. Date : 2013-08-29
DMF Number : 22589
Submission : 2009-02-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19679
Submission : 2006-08-10
Status : Inactive
Type : II
A Nafcillin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nafcillin, including repackagers and relabelers. The FDA regulates Nafcillin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nafcillin 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 Nafcillin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nafcillin supplier is an individual or a company that provides Nafcillin active pharmaceutical ingredient (API) or Nafcillin finished formulations upon request. The Nafcillin suppliers may include Nafcillin API manufacturers, exporters, distributors and traders.
click here to find a list of Nafcillin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nafcillin DMF (Drug Master File) is a document detailing the whole manufacturing process of Nafcillin active pharmaceutical ingredient (API) in detail. Different forms of Nafcillin DMFs exist exist since differing nations have different regulations, such as Nafcillin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nafcillin DMF submitted to regulatory agencies in the US is known as a USDMF. Nafcillin USDMF includes data on Nafcillin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nafcillin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nafcillin suppliers with USDMF on PharmaCompass.
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