01 1Cody Laboratories, Inc.
02 1Mallinckrodt Pharmaceuticals
03 1National Institute on Drug Abuse
01 1COCAINE HYDROCHLORIDE INJECTABLES
02 1COCAINE HYDROCHLORIDE USP
03 1COCAINE HYDROCHLORIDE, USP
01 1Ireland
02 2U.S.A
01 2Active
02 1Inactive
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29120
Submission : 2017-08-04
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-23
Pay. Date : 2018-02-05
DMF Number : 20995
Submission : 2007-11-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16579
Submission : 2003-05-09
Status : Active
Type : II
A Cocaine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cocaine Hydrochloride, including repackagers and relabelers. The FDA regulates Cocaine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cocaine Hydrochloride 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 Cocaine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cocaine Hydrochloride supplier is an individual or a company that provides Cocaine Hydrochloride active pharmaceutical ingredient (API) or Cocaine Hydrochloride finished formulations upon request. The Cocaine Hydrochloride suppliers may include Cocaine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Cocaine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cocaine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Cocaine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Cocaine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Cocaine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cocaine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Cocaine Hydrochloride USDMF includes data on Cocaine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cocaine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cocaine Hydrochloride suppliers with USDMF on PharmaCompass.
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