01 1Inner Mongolia Changsheng Pharmaceutical
02 1Jiangxi Fushine Pharmaceutical Co. Ltd
01 1SULBACTAM
02 1SULBACTAM ACID
01 2China
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38539
Submission : 2023-06-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-06
Pay. Date : 2012-12-27
DMF Number : 25609
Submission : 2011-10-25
Status : Active
Type : II
A Sulbactam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulbactam, including repackagers and relabelers. The FDA regulates Sulbactam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulbactam 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 Sulbactam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulbactam supplier is an individual or a company that provides Sulbactam active pharmaceutical ingredient (API) or Sulbactam finished formulations upon request. The Sulbactam suppliers may include Sulbactam API manufacturers, exporters, distributors and traders.
click here to find a list of Sulbactam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulbactam DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulbactam active pharmaceutical ingredient (API) in detail. Different forms of Sulbactam DMFs exist exist since differing nations have different regulations, such as Sulbactam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sulbactam DMF submitted to regulatory agencies in the US is known as a USDMF. Sulbactam USDMF includes data on Sulbactam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulbactam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sulbactam suppliers with USDMF on PharmaCompass.
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