Veranova: A CDMO that manages complexity with confidence.
01 2Veranova
02 3Noramco
03 1Alkem Laboratories
04 1American Pacific Corporation
05 1Boehringer Ingelheim GmbH
06 1Cambrex Corporation
07 1Chattem Chemicals, Inc
08 1Cody Laboratories, Inc.
09 1Curia
10 1Ipca Laboratories
11 2Johnson & Johnson Innovative Medicine
12 2Mallinckrodt Pharmaceuticals
13 1Novartis Pharmaceuticals Corporation
14 1Siegfried AG
15 1UCB Pharma S.A
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10137
Submission : 1993-03-05
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-27
Pay. Date : 2012-11-23
DMF Number : 22244
Submission : 2008-12-19
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-07
DMF Number : 19547
Submission : 2006-06-26
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-07
Pay. Date : 2013-07-19
DMF Number : 27208
Submission : 2013-07-12
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-19
Pay. Date : 2015-09-15
DMF Number : 29411
Submission : 2016-05-27
Status :
Type : II
A Concerta manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Concerta, including repackagers and relabelers. The FDA regulates Concerta manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Concerta 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 Concerta manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Concerta supplier is an individual or a company that provides Concerta active pharmaceutical ingredient (API) or Concerta finished formulations upon request. The Concerta suppliers may include Concerta API manufacturers, exporters, distributors and traders.
click here to find a list of Concerta suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Concerta DMF (Drug Master File) is a document detailing the whole manufacturing process of Concerta active pharmaceutical ingredient (API) in detail. Different forms of Concerta DMFs exist exist since differing nations have different regulations, such as Concerta USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Concerta DMF submitted to regulatory agencies in the US is known as a USDMF. Concerta USDMF includes data on Concerta's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Concerta USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Concerta suppliers with USDMF on PharmaCompass.
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