TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
01 1TAPI Technology & API Services
02 1DZD Heze Pharmaceutical Co Ltd
03 1Synbias Pharma Limited Liability Company
01 1VALRUBICIN
02 1VALRUBICIN (AD-32)
03 1VALRUBICIN USP
01 1China
02 1Israel
03 1Ukraine
01 3Active
01 1Complete
02 2Blank
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12405
Submission : 1997-03-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34521
Submission : 2020-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-04
Pay. Date : 2013-04-15
DMF Number : 26918
Submission : 2013-02-26
Status : Active
Type : II
A Valrubicin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valrubicin, including repackagers and relabelers. The FDA regulates Valrubicin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valrubicin 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 Valrubicin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valrubicin supplier is an individual or a company that provides Valrubicin active pharmaceutical ingredient (API) or Valrubicin finished formulations upon request. The Valrubicin suppliers may include Valrubicin API manufacturers, exporters, distributors and traders.
click here to find a list of Valrubicin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valrubicin DMF (Drug Master File) is a document detailing the whole manufacturing process of Valrubicin active pharmaceutical ingredient (API) in detail. Different forms of Valrubicin DMFs exist exist since differing nations have different regulations, such as Valrubicin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valrubicin DMF submitted to regulatory agencies in the US is known as a USDMF. Valrubicin USDMF includes data on Valrubicin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valrubicin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valrubicin suppliers with USDMF on PharmaCompass.
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