Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
01 2Noramco
02 1Veranova
03 1Aspen API
04 1TAPI Technology & API Services
05 2Arevipharma
06 1Cambrex Corporation
07 1Chattem Chemicals, Inc
08 1Chr. Olesen Synthesis A.S
09 2Mallinckrodt Pharmaceuticals
10 1Reckitt Benckiser
11 1Resonance Laboratories Pvt. Ltd
12 1Salars Spa
13 3Siegfried AG
14 1Sun Pharmaceutical Industries Limited
15 2Unichem Laboratories Limited
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-23
DMF Number : 23683
Submission : 2010-04-05
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-30
DMF Number : 19109
Submission : 2006-01-12
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7099
Submission : 1987-08-06
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-30
Pay. Date : 2012-11-13
DMF Number : 16419
Submission : 2003-01-29
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-04
Pay. Date : 2016-09-08
DMF Number : 29885
Submission : 2016-08-16
Status :
Type : II
A SUBOXONE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SUBOXONE, including repackagers and relabelers. The FDA regulates SUBOXONE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SUBOXONE 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 SUBOXONE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SUBOXONE supplier is an individual or a company that provides SUBOXONE active pharmaceutical ingredient (API) or SUBOXONE finished formulations upon request. The SUBOXONE suppliers may include SUBOXONE API manufacturers, exporters, distributors and traders.
click here to find a list of SUBOXONE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SUBOXONE DMF (Drug Master File) is a document detailing the whole manufacturing process of SUBOXONE active pharmaceutical ingredient (API) in detail. Different forms of SUBOXONE DMFs exist exist since differing nations have different regulations, such as SUBOXONE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SUBOXONE DMF submitted to regulatory agencies in the US is known as a USDMF. SUBOXONE USDMF includes data on SUBOXONE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SUBOXONE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SUBOXONE suppliers with USDMF on PharmaCompass.
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