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 : 15159
Submission : 2000-11-27
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 : 25573
Submission : 2011-12-08
Status : Active
Type : II
57
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A Gerovit manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gerovit, including repackagers and relabelers. The FDA regulates Gerovit manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gerovit 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 Gerovit supplier is an individual or a company that provides Gerovit active pharmaceutical ingredient (API) or Gerovit finished formulations upon request. The Gerovit suppliers may include Gerovit API manufacturers, exporters, distributors and traders.
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A Gerovit DMF (Drug Master File) is a document detailing the whole manufacturing process of Gerovit active pharmaceutical ingredient (API) in detail. Different forms of Gerovit DMFs exist exist since differing nations have different regulations, such as Gerovit USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gerovit DMF submitted to regulatory agencies in the US is known as a USDMF. Gerovit USDMF includes data on Gerovit's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gerovit USDMF is kept confidential to protect the manufacturer’s intellectual property.
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