ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1MSN Laboratories
03 1RANBAXY LABORATORIES LIMITED
04 1Signa S.A. de C.V.
05 1Sun Pharmaceutical Industries Limited
06 1Unichem Laboratories Limited
01 1TIAGABINE HYDROCHLORIDE
02 1TIAGABINE HYDROCHLORIDE MONOHYDRATE USP
03 4TIAGABINE HYDROCHLORIDE USP
01 4India
02 1Mexico
03 1U.S.A
01 3Active
02 3Inactive
01 2Complete
02 4Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-05
Pay. Date : 2013-11-26
DMF Number : 22033
Submission : 2008-09-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-06
Pay. Date : 2019-09-25
DMF Number : 33494
Submission : 2018-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18934
Submission : 2005-11-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27380
Submission : 2013-12-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17978
Submission : 2005-01-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27286
Submission : 2013-08-26
Status : Inactive
Type : II
A Tiagabine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tiagabine Hydrochloride, including repackagers and relabelers. The FDA regulates Tiagabine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tiagabine 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 Tiagabine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tiagabine Hydrochloride supplier is an individual or a company that provides Tiagabine Hydrochloride active pharmaceutical ingredient (API) or Tiagabine Hydrochloride finished formulations upon request. The Tiagabine Hydrochloride suppliers may include Tiagabine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Tiagabine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tiagabine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Tiagabine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Tiagabine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Tiagabine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tiagabine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Tiagabine Hydrochloride USDMF includes data on Tiagabine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tiagabine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tiagabine Hydrochloride suppliers with USDMF on PharmaCompass.
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