01 1Ahk Tech
02 1Apotex Pharmachem
03 1Archimica
04 1Asahi Kasei Finechem
05 1Axitec
06 1Linnea SA
07 1Mac-Chem Products (India) Pvt.Ltd
08 1Pfizer Inc
09 1Roche Diagnostics GmbH
10 1Zhejiang Hisun Pharmaceutical
11 5Blank
01 1ALEXAN 1000 MG/20 ML VIAL (5% CYTARABINE SOLUTION) W. GERMANY
02 1ALEXAN 100mg/5ml VIAL(2% CYTARABINE SOLUTION)
03 5CYTARABINE
04 2CYTARABINE USP
05 1CYTARABINE USP NON-STERILE BULK DRUG
06 1CYTARABINE USP XXI
07 1CYTARABINE, USP
08 1CYTARBINE
09 1CYTOSINE - ARABINOFURANOSIDE
10 1CYTOSINE ARABINOSIDE
01 1Canada
02 3China
03 1Germany
04 1India
05 1Italy
06 1Japan
07 1Switzerland
08 1U.S.A
09 5Blank
01 3Active
02 12Inactive
01 3Complete
02 12Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7364
Submission : 1988-03-04
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-18
Pay. Date : 2013-01-15
DMF Number : 25267
Submission : 2011-09-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-30
Pay. Date : 2017-06-08
DMF Number : 6215
Submission : 1986-01-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7770
Submission : 1988-11-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1534
Submission : 1970-06-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-18
Pay. Date : 2012-12-18
DMF Number : 15959
Submission : 2002-04-28
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7612
Submission : 1988-08-03
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 : 7544
Submission : 1988-06-15
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 : 5311
Submission : 1984-03-19
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 : 1428
Submission : 1969-08-20
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Alexan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alexan, including repackagers and relabelers. The FDA regulates Alexan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alexan 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 Alexan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alexan supplier is an individual or a company that provides Alexan active pharmaceutical ingredient (API) or Alexan finished formulations upon request. The Alexan suppliers may include Alexan API manufacturers, exporters, distributors and traders.
click here to find a list of Alexan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alexan DMF (Drug Master File) is a document detailing the whole manufacturing process of Alexan active pharmaceutical ingredient (API) in detail. Different forms of Alexan DMFs exist exist since differing nations have different regulations, such as Alexan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alexan DMF submitted to regulatory agencies in the US is known as a USDMF. Alexan USDMF includes data on Alexan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alexan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alexan suppliers with USDMF on PharmaCompass.
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