TAPI offers customized CDMO Solutions for API development and manufacturing services.
01 1TAPI Technology & API Services
02 1Celgene Corporation
03 1Concord Biotech
04 1MSN Laboratories
05 1Zhejiang Hisun Pharmaceutical
01 1FR901228
02 4ROMIDEPSIN
01 1China
02 2India
03 1Israel
04 1U.S.A
01 3Active
02 2Inactive
01 3Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-10
Pay. Date : 2013-08-16
DMF Number : 27400
Submission : 2013-09-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12079
Submission : 1996-08-07
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-15
Pay. Date : 2013-10-25
DMF Number : 27399
Submission : 2013-11-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-15
Pay. Date : 2019-05-28
DMF Number : 33497
Submission : 2019-01-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33235
Submission : 2018-09-29
Status : Inactive
Type : II
A Romidepsin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Romidepsin, including repackagers and relabelers. The FDA regulates Romidepsin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Romidepsin 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 Romidepsin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Romidepsin supplier is an individual or a company that provides Romidepsin active pharmaceutical ingredient (API) or Romidepsin finished formulations upon request. The Romidepsin suppliers may include Romidepsin API manufacturers, exporters, distributors and traders.
click here to find a list of Romidepsin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Romidepsin DMF (Drug Master File) is a document detailing the whole manufacturing process of Romidepsin active pharmaceutical ingredient (API) in detail. Different forms of Romidepsin DMFs exist exist since differing nations have different regulations, such as Romidepsin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Romidepsin DMF submitted to regulatory agencies in the US is known as a USDMF. Romidepsin USDMF includes data on Romidepsin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Romidepsin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Romidepsin suppliers with USDMF on PharmaCompass.
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