01 1Boehringer Ingelheim GmbH
02 1CQ INTERNATIONAL CO INC
03 1S M HERBALS PVT LTD
04 1SAFC
05 1Sai Phytoceuticals
01 3CAMPTOTHECIN
02 1CAMPTOTHECIN [CAS NO. 7689-03-4]
03 1Camptothecin-20(s)-O-Propionate Hydrate
01 1Germany
02 2India
03 2U.S.A
01 5Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11714
Submission : 1995-10-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16115
Submission : 2002-08-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20060
Submission : 2006-11-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21128
Submission : 2007-12-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20055
Submission : 2006-12-08
Status : Inactive
Type : II
A Camptothecine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Camptothecine, including repackagers and relabelers. The FDA regulates Camptothecine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Camptothecine 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 Camptothecine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Camptothecine supplier is an individual or a company that provides Camptothecine active pharmaceutical ingredient (API) or Camptothecine finished formulations upon request. The Camptothecine suppliers may include Camptothecine API manufacturers, exporters, distributors and traders.
click here to find a list of Camptothecine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Camptothecine DMF (Drug Master File) is a document detailing the whole manufacturing process of Camptothecine active pharmaceutical ingredient (API) in detail. Different forms of Camptothecine DMFs exist exist since differing nations have different regulations, such as Camptothecine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Camptothecine DMF submitted to regulatory agencies in the US is known as a USDMF. Camptothecine USDMF includes data on Camptothecine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Camptothecine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Camptothecine suppliers with USDMF on PharmaCompass.
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