01 1ACS DOBFAR SPA
02 1Qilu Antibiotics Pharmaceutical Co., Ltd.
01 1CEFTAROLINE FOSAMIL STERILE DRUG SUBSTANCE
02 1STERILE CEFTAROLINE FOSAMIL WITH ARGININE
01 1China
02 1Italy
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23167
Submission : 2009-10-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-27
Pay. Date : 2014-05-16
DMF Number : 28245
Submission : 2014-06-25
Status : Active
Type : II
A Ceftaroline Fosamil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ceftaroline Fosamil, including repackagers and relabelers. The FDA regulates Ceftaroline Fosamil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ceftaroline Fosamil 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 Ceftaroline Fosamil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ceftaroline Fosamil supplier is an individual or a company that provides Ceftaroline Fosamil active pharmaceutical ingredient (API) or Ceftaroline Fosamil finished formulations upon request. The Ceftaroline Fosamil suppliers may include Ceftaroline Fosamil API manufacturers, exporters, distributors and traders.
click here to find a list of Ceftaroline Fosamil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ceftaroline Fosamil DMF (Drug Master File) is a document detailing the whole manufacturing process of Ceftaroline Fosamil active pharmaceutical ingredient (API) in detail. Different forms of Ceftaroline Fosamil DMFs exist exist since differing nations have different regulations, such as Ceftaroline Fosamil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ceftaroline Fosamil DMF submitted to regulatory agencies in the US is known as a USDMF. Ceftaroline Fosamil USDMF includes data on Ceftaroline Fosamil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ceftaroline Fosamil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ceftaroline Fosamil suppliers with USDMF on PharmaCompass.
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