Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
01 1Noramco
02 2Alkem Laboratories
03 1American Pacific Corporation
04 1Curia
01 1TAPENTADOL HCI
02 2TAPENTADOL HYDROCHLORIDE
03 1TAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE
04 1TAPENTADOL HYDROCHLORIDE DRUG SUBSTANCE
01 2India
02 3U.S.A
01 5Active
01 4Complete
02 1Blank
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-05
Pay. Date : 2020-07-30
DMF Number : 21084
Submission : 2008-01-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-18
Pay. Date : 2017-03-30
DMF Number : 31435
Submission : 2017-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-01
Pay. Date : 2012-11-08
DMF Number : 26519
Submission : 2012-10-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28541
Submission : 2014-09-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-13
Pay. Date : 2012-11-02
DMF Number : 26490
Submission : 2012-09-27
Status : Active
Type : II
A Tapentadol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tapentadol, including repackagers and relabelers. The FDA regulates Tapentadol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tapentadol 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 Tapentadol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tapentadol supplier is an individual or a company that provides Tapentadol active pharmaceutical ingredient (API) or Tapentadol finished formulations upon request. The Tapentadol suppliers may include Tapentadol API manufacturers, exporters, distributors and traders.
click here to find a list of Tapentadol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tapentadol DMF (Drug Master File) is a document detailing the whole manufacturing process of Tapentadol active pharmaceutical ingredient (API) in detail. Different forms of Tapentadol DMFs exist exist since differing nations have different regulations, such as Tapentadol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tapentadol DMF submitted to regulatory agencies in the US is known as a USDMF. Tapentadol USDMF includes data on Tapentadol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tapentadol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tapentadol suppliers with USDMF on PharmaCompass.
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