01 1Asia Pioneer Pharmaceuticals
02 1Concord Biotech
03 1SAFC
04 1Sigma-Aldrich Corporation
05 1Zhejiang Hisun Pharmaceutical
01 1China
02 1India
03 3U.S.A
01 3Active
02 1Inactive
03 1Blank
01 5Blank
01 1221MF10187
02 4Blank
01 1WC-0111
02 4Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2020-02-04
Pay. Date : 2019-10-25
DMF Number : 34247
Submission : 2019-11-06
Status : Active
Type : II
Date of Issue : 2019-09-23
Valid Till : 2022-07-02
Written Confirmation Number : WC-0111
Address of the Firm :
NDC Package Code : 68254-0017
Start Marketing Date : 2016-05-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3538
Submission : 1979-04-03
Status : Active
Type : II
Registration Number : 221MF10187
Registrant's Address : 13 Kiryat Mada Street, Har Hotzvim Industrial Park Jerusalem, 97770 ISRAEL
Initial Date of Registration : 2009-08-13
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-09
Pay. Date : 2012-12-18
DMF Number : 20658
Submission : 2007-06-20
Status : Active
Type : II
NDC Package Code : 58623-0098
Start Marketing Date : 2010-03-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2020-07-14
Registration Number : 20200714-210-J-490
Manufacturer Name : Zhejiang Hisun Pharmaceutical. Co., Ltd.
Manufacturer Address : No. 56 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13633
Submission : 1998-09-01
Status : Inactive
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.
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