01 1Amsa Spa
02 1Medimpex
03 1Napp Technologies
04 1RP SCHERER GMBH & CO. KG
05 1Blank
01 3PHENYLBUTAZONE
02 1PHENYLBUTAZONE CAPSULES 100MG
03 1PHENYLBUTAZONE USP
01 1Germany
02 1Italy
03 1U.S.A
04 1United Kingdom
05 1Blank
01 5Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1548
Submission : 1970-07-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2547
Submission : 1975-10-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2423
Submission : 1975-03-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1925
Submission : 1972-05-01
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1702
Submission : 1970-12-17
Status : Inactive
Type : II
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Corporate PDF
A Phenylbutazone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenylbutazone, including repackagers and relabelers. The FDA regulates Phenylbutazone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenylbutazone 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 Phenylbutazone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenylbutazone supplier is an individual or a company that provides Phenylbutazone active pharmaceutical ingredient (API) or Phenylbutazone finished formulations upon request. The Phenylbutazone suppliers may include Phenylbutazone API manufacturers, exporters, distributors and traders.
click here to find a list of Phenylbutazone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phenylbutazone DMF (Drug Master File) is a document detailing the whole manufacturing process of Phenylbutazone active pharmaceutical ingredient (API) in detail. Different forms of Phenylbutazone DMFs exist exist since differing nations have different regulations, such as Phenylbutazone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phenylbutazone DMF submitted to regulatory agencies in the US is known as a USDMF. Phenylbutazone USDMF includes data on Phenylbutazone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phenylbutazone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phenylbutazone suppliers with USDMF on PharmaCompass.
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