01 1Grindeks AS
02 1Industriale Chimica
03 1Johnson & Johnson Innovative Medicine
04 1Merck & Co
05 1Xian Libang Pharmaceutical Co.,Ltd
01 2DROPERIDOL
02 1DROPERIDOL USP
03 1DROPERIDOL USP, NON-STERILE BULK DRUG INTENDED FOR HUMAN USE
04 1DROPERIDOL,CODE#R4749,MNFG IN BELGIUM AND PUERTO RICO FACILITIES
01 1China
02 1Italy
03 1Latvia
04 2U.S.A
01 1Active
02 4Inactive
01 1Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-15
Pay. Date : 2012-11-23
DMF Number : 22975
Submission : 2009-07-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7539
Submission : 1988-06-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4890
Submission : 1983-03-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5773
Submission : 1985-03-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13897
Submission : 1998-12-16
Status : Inactive
Type : II
A Droperidol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Droperidol, including repackagers and relabelers. The FDA regulates Droperidol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Droperidol 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 Droperidol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Droperidol supplier is an individual or a company that provides Droperidol active pharmaceutical ingredient (API) or Droperidol finished formulations upon request. The Droperidol suppliers may include Droperidol API manufacturers, exporters, distributors and traders.
click here to find a list of Droperidol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Droperidol DMF (Drug Master File) is a document detailing the whole manufacturing process of Droperidol active pharmaceutical ingredient (API) in detail. Different forms of Droperidol DMFs exist exist since differing nations have different regulations, such as Droperidol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Droperidol DMF submitted to regulatory agencies in the US is known as a USDMF. Droperidol USDMF includes data on Droperidol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Droperidol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Droperidol suppliers with USDMF on PharmaCompass.
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