01 1Actylis
02 1Cardinal Health
03 1HUAYI ISOTOPE CO
04 1IBA MOLECULAR NORTH AMERICA INC
05 1JIAOZUO JOINCARE BIOTECHNOLOGICAL CO LTD
06 1Lonza Group
07 1MIDWEST MEDICAL ISOTOPES LLC CYCLOTRON DIV
08 1National Institutes of Health
09 1SIGMA TAU
10 1SPECTRON MRC LLC
11 1Siemens Molecular Imaging
12 1The University of Texas MD Anderson Cancer Center
13 1Yamasa Corporation
14 2Blank
01 13'-DEOXY-3'-[18F]FLUOROTHYMIDINE
02 13'-DEOXY-3'-[18F]FLUOROTHYMIDINE ([18F]FLT)
03 13'-DEOXY-3'-[F-18] FLUOROTHYMIDINE (18F-FLT) INJECTION
04 13'-deoxy-3'-[18F]Fluorothymidine
05 13-DEOXY-3-[18F]FLUOROTHYMIDINE ([18F]FLT)
06 1NON-PRODUCT SPECIFIC DOCUMENTATION FOR STERILIZATION PROCESS VALIDATION APPLICATIONS FOR HUMAN AND VETERINARY DRUG PRODUCTS
07 1STERILE NON-PYROGENIC 3'-DEOXY-3'-[18F]FLUOROTHYMIDINE ([18F]FLT)
08 7THYMIDINE
09 1THYMIDINE (NSC21548)
01 2China
02 1Germany
03 1Japan
04 1Switzerland
05 8U.S.A
06 2Blank
01 3Active
02 12Inactive
01 15Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3276
Submission : 1978-06-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25370
Submission : 2011-10-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15497
Submission : 2001-06-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21078
Submission : 2007-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2969
Submission : 1977-06-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20022
Submission : 2006-12-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3278
Submission : 1978-08-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11945
Submission : 1996-04-24
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7698
Submission : 1988-09-29
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 : 3154
Submission : 1978-02-27
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Thymidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thymidine, including repackagers and relabelers. The FDA regulates Thymidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thymidine 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 Thymidine supplier is an individual or a company that provides Thymidine active pharmaceutical ingredient (API) or Thymidine finished formulations upon request. The Thymidine suppliers may include Thymidine API manufacturers, exporters, distributors and traders.
click here to find a list of Thymidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Thymidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Thymidine active pharmaceutical ingredient (API) in detail. Different forms of Thymidine DMFs exist exist since differing nations have different regulations, such as Thymidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thymidine DMF submitted to regulatory agencies in the US is known as a USDMF. Thymidine USDMF includes data on Thymidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thymidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Thymidine suppliers with USDMF on PharmaCompass.
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