Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
01 1Noramco
02 2Alkem Laboratories
03 1American Pacific Corporation
04 1Curia
05 1MSN Laboratories
01 1TAPENTADOL HCI
02 3TAPENTADOL HYDROCHLORIDE
03 1TAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE
04 1TAPENTADOL HYDROCHLORIDE DRUG SUBSTANCE
01 3India
02 3U.S.A
01 6Active
01 4Complete
02 2Blank
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41316
Submission : 2025-02-28
Status : Active
Type : II
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A Nucynta ER manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nucynta ER, including repackagers and relabelers. The FDA regulates Nucynta ER manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nucynta ER 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 Nucynta ER supplier is an individual or a company that provides Nucynta ER active pharmaceutical ingredient (API) or Nucynta ER finished formulations upon request. The Nucynta ER suppliers may include Nucynta ER API manufacturers, exporters, distributors and traders.
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A Nucynta ER DMF (Drug Master File) is a document detailing the whole manufacturing process of Nucynta ER active pharmaceutical ingredient (API) in detail. Different forms of Nucynta ER DMFs exist exist since differing nations have different regulations, such as Nucynta ER USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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We have 5 companies offering Nucynta ER
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