01 2HEMISPHERX BIOPHARMA INC
01 1ALFERON N INJECTION
02 1INTERFERON ALFA-N3 GEL (HUMAN LEUKOCYTE, INTERFERON SCIENCES)
01 2U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27142
Submission : 1980-10-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18614
Submission : 1992-10-22
Status : Inactive
Type : II
A PEGINTERFERON ALFA-2B manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PEGINTERFERON ALFA-2B, including repackagers and relabelers. The FDA regulates PEGINTERFERON ALFA-2B manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PEGINTERFERON ALFA-2B 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 PEGINTERFERON ALFA-2B manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PEGINTERFERON ALFA-2B supplier is an individual or a company that provides PEGINTERFERON ALFA-2B active pharmaceutical ingredient (API) or PEGINTERFERON ALFA-2B finished formulations upon request. The PEGINTERFERON ALFA-2B suppliers may include PEGINTERFERON ALFA-2B API manufacturers, exporters, distributors and traders.
click here to find a list of PEGINTERFERON ALFA-2B suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PEGINTERFERON ALFA-2B DMF (Drug Master File) is a document detailing the whole manufacturing process of PEGINTERFERON ALFA-2B active pharmaceutical ingredient (API) in detail. Different forms of PEGINTERFERON ALFA-2B DMFs exist exist since differing nations have different regulations, such as PEGINTERFERON ALFA-2B USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PEGINTERFERON ALFA-2B DMF submitted to regulatory agencies in the US is known as a USDMF. PEGINTERFERON ALFA-2B USDMF includes data on PEGINTERFERON ALFA-2B's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PEGINTERFERON ALFA-2B USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PEGINTERFERON ALFA-2B suppliers with USDMF on PharmaCompass.
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