01 1Catalytica
02 1Esteve Quimica
03 1Johnson & Johnson Innovative Medicine
04 1Quimica Sintetica
05 2Blank
01 4ASTEMIZOLE
02 1ASTEMIZOLE INTERMEDIATES
03 1ASTEMIZOLE-R 43512
01 1India
02 2Spain
03 1U.S.A
04 2Blank
01 6Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10889
Submission : 1994-05-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11584
Submission : 1995-07-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5172
Submission : 1983-11-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9443
Submission : 1991-11-11
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9599
Submission : 1992-03-04
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 : 8510
Submission : 1990-04-04
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Astemizole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Astemizole, including repackagers and relabelers. The FDA regulates Astemizole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Astemizole 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 Astemizole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Astemizole supplier is an individual or a company that provides Astemizole active pharmaceutical ingredient (API) or Astemizole finished formulations upon request. The Astemizole suppliers may include Astemizole API manufacturers, exporters, distributors and traders.
click here to find a list of Astemizole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Astemizole DMF (Drug Master File) is a document detailing the whole manufacturing process of Astemizole active pharmaceutical ingredient (API) in detail. Different forms of Astemizole DMFs exist exist since differing nations have different regulations, such as Astemizole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Astemizole DMF submitted to regulatory agencies in the US is known as a USDMF. Astemizole USDMF includes data on Astemizole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Astemizole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Astemizole suppliers with USDMF on PharmaCompass.
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