01 1Ash Stevens
02 3Blank
01 110B ENRICHED P-BORONOPHENYLALANINE
02 110B-ENRICHED L-P-BORONOPHENYLALANINE
03 1B-ENRICHED L-P-BORONPHENYLALANINE
04 1P-BORONO-L-PHENYLALANINE (B-10 ENRICHED)
01 1U.S.A
02 3Blank
01 4Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11208
Submission : 1994-11-23
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13007
Submission : 1998-05-28
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13005
Submission : 1998-05-28
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11538
Submission : 1995-05-26
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A P-Borono-L-Phenylalanine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of P-Borono-L-Phenylalanine, including repackagers and relabelers. The FDA regulates P-Borono-L-Phenylalanine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. P-Borono-L-Phenylalanine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A P-Borono-L-Phenylalanine supplier is an individual or a company that provides P-Borono-L-Phenylalanine active pharmaceutical ingredient (API) or P-Borono-L-Phenylalanine finished formulations upon request. The P-Borono-L-Phenylalanine suppliers may include P-Borono-L-Phenylalanine API manufacturers, exporters, distributors and traders.
click here to find a list of P-Borono-L-Phenylalanine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A P-Borono-L-Phenylalanine DMF (Drug Master File) is a document detailing the whole manufacturing process of P-Borono-L-Phenylalanine active pharmaceutical ingredient (API) in detail. Different forms of P-Borono-L-Phenylalanine DMFs exist exist since differing nations have different regulations, such as P-Borono-L-Phenylalanine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A P-Borono-L-Phenylalanine DMF submitted to regulatory agencies in the US is known as a USDMF. P-Borono-L-Phenylalanine USDMF includes data on P-Borono-L-Phenylalanine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The P-Borono-L-Phenylalanine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of P-Borono-L-Phenylalanine suppliers with USDMF on PharmaCompass.
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