Veranova: A CDMO that manages complexity with confidence.
01 1Veranova
02 1Chattem Chemicals, Inc
03 2National Institute on Drug Abuse
04 1Norac Pharma
01 1(S)-(+)-METHAMPHETAMINE HYDROCHLORIDE
02 1METHAMPHETAMINE HCI
03 1METHAMPHETAMINE HYDROCHLORIDE USP
04 1METHAMPHETAMINE HYDROCHLORIDE, INJECTABLE 10MG/1ML, 5ML AMPOULES
05 1NGT-10100 (METHAMPHETAMINE HYDROCHLORIDE)
01 5U.S.A
01 5Active
01 1Complete
02 4Blank
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-05
Pay. Date : 2022-08-03
DMF Number : 22245
Submission : 2008-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16176
Submission : 2002-10-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15465
Submission : 2001-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15159
Submission : 2000-11-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25573
Submission : 2011-12-08
Status : Active
Type : II
57
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A Desoxyn manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Desoxyn, including repackagers and relabelers. The FDA regulates Desoxyn manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Desoxyn API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Desoxyn supplier is an individual or a company that provides Desoxyn active pharmaceutical ingredient (API) or Desoxyn finished formulations upon request. The Desoxyn suppliers may include Desoxyn API manufacturers, exporters, distributors and traders.
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A Desoxyn DMF (Drug Master File) is a document detailing the whole manufacturing process of Desoxyn active pharmaceutical ingredient (API) in detail. Different forms of Desoxyn DMFs exist exist since differing nations have different regulations, such as Desoxyn USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Desoxyn DMF submitted to regulatory agencies in the US is known as a USDMF. Desoxyn USDMF includes data on Desoxyn's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Desoxyn USDMF is kept confidential to protect the manufacturer’s intellectual property.
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