01 1Concord Biotech
02 1SAFC
03 1Sigma-Aldrich Corporation
04 1Zhejiang Hisun Pharmaceutical
01 1DACTINOMYCIN
02 3DACTINOMYCIN USP
01 1China
02 1India
03 2U.S.A
01 3Active
02 1Inactive
01 2Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2020-02-04
Pay. Date : 2019-10-25
DMF Number : 34247
Submission : 2019-11-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3538
Submission : 1979-04-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13633
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-18
DMF Number : 20658
Submission : 2007-06-20
Status : Active
Type : II
A Dactinomycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dactinomycin, including repackagers and relabelers. The FDA regulates Dactinomycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dactinomycin 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 Dactinomycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dactinomycin supplier is an individual or a company that provides Dactinomycin active pharmaceutical ingredient (API) or Dactinomycin finished formulations upon request. The Dactinomycin suppliers may include Dactinomycin API manufacturers, exporters, distributors and traders.
click here to find a list of Dactinomycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dactinomycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Dactinomycin active pharmaceutical ingredient (API) in detail. Different forms of Dactinomycin DMFs exist exist since differing nations have different regulations, such as Dactinomycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dactinomycin DMF submitted to regulatory agencies in the US is known as a USDMF. Dactinomycin USDMF includes data on Dactinomycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dactinomycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dactinomycin suppliers with USDMF on PharmaCompass.
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