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
A Pivmecillinam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pivmecillinam, including repackagers and relabelers. The FDA regulates Pivmecillinam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pivmecillinam 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 Pivmecillinam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pivmecillinam supplier is an individual or a company that provides Pivmecillinam active pharmaceutical ingredient (API) or Pivmecillinam finished formulations upon request. The Pivmecillinam suppliers may include Pivmecillinam API manufacturers, exporters, distributors and traders.
click here to find a list of Pivmecillinam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pivmecillinam DMF (Drug Master File) is a document detailing the whole manufacturing process of Pivmecillinam active pharmaceutical ingredient (API) in detail. Different forms of Pivmecillinam DMFs exist exist since differing nations have different regulations, such as Pivmecillinam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pivmecillinam DMF submitted to regulatory agencies in the US is known as a USDMF. Pivmecillinam USDMF includes data on Pivmecillinam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pivmecillinam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pivmecillinam suppliers with USDMF on PharmaCompass.
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