01 1Fresenius SE & Co. KGaA
01 1PIVMECILLINAM HYDROCHLORIDE
01 1Germany
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35278
Submission : 2021-10-15
Status : Active
Type : II
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A Selexid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Selexid, including repackagers and relabelers. The FDA regulates Selexid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Selexid 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 Selexid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Selexid supplier is an individual or a company that provides Selexid active pharmaceutical ingredient (API) or Selexid finished formulations upon request. The Selexid suppliers may include Selexid API manufacturers, exporters, distributors and traders.
click here to find a list of Selexid suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Selexid DMF (Drug Master File) is a document detailing the whole manufacturing process of Selexid active pharmaceutical ingredient (API) in detail. Different forms of Selexid DMFs exist exist since differing nations have different regulations, such as Selexid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Selexid DMF submitted to regulatory agencies in the US is known as a USDMF. Selexid USDMF includes data on Selexid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Selexid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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