01 1Newgen Biotech USA
02 1Specialty Enzymes & Probiotics
01 1SERRAPEPTASE
02 1SERRATIOPEPTIDASE
01 2U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27172
Submission : 2013-05-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23557
Submission : 2010-02-16
Status : Inactive
Type : II
A Serratiopeptidase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Serratiopeptidase, including repackagers and relabelers. The FDA regulates Serratiopeptidase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Serratiopeptidase 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 Serratiopeptidase manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Serratiopeptidase supplier is an individual or a company that provides Serratiopeptidase active pharmaceutical ingredient (API) or Serratiopeptidase finished formulations upon request. The Serratiopeptidase suppliers may include Serratiopeptidase API manufacturers, exporters, distributors and traders.
click here to find a list of Serratiopeptidase suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Serratiopeptidase DMF (Drug Master File) is a document detailing the whole manufacturing process of Serratiopeptidase active pharmaceutical ingredient (API) in detail. Different forms of Serratiopeptidase DMFs exist exist since differing nations have different regulations, such as Serratiopeptidase USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Serratiopeptidase DMF submitted to regulatory agencies in the US is known as a USDMF. Serratiopeptidase USDMF includes data on Serratiopeptidase's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Serratiopeptidase USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Serratiopeptidase suppliers with USDMF on PharmaCompass.
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