Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
01 1NORAMCO, LLC. Wilmington US
02 1SANOFI CHIMIE Gentilly FR
03 1MACFARLAN SMITH LIMITED Edinburgh GB
04 2RUSAN PHARMA LTD Mumbai IN
05 1TEVA CZECH INDUSTRIES S.R.O. Opava CZ
06 2AREVIPHARMA GMBH Radebeul DE
07 1CHR. OLESEN SYNTHESIS A/S Hvidovre DK
08 1N.V. ORGANON Oss NL
09 1PIONEER AGRO INDUSTRIES SANVIN LABORATORIES PRIVATE LIMITED Mumbai IN
10 1PharmaZell GmbH Raubling DE
11 1RESONANCE LABORATORIES PVT. LTD. Bangalore IN
12 1SIEGFRIED AG Zofingen CH
13 1SIEGFRIED LTD. Zofingen CH
14 2SPECGX LLC Webster Groves US
15 1SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN
16 1Unichem Laboratories Limited Mumbai IN
01 16Buprenorphine hydrochloride
02 2Buprenorphine hydrochloride, Process II
03 1Buprenorphine hydrochloride, Process N
01 1Denmark
02 1France
03 3Germany
04 6India
05 1Ireland
06 1Israel
07 2Switzerland
08 3U.S.A
09 1United Kingdom
01 1Expired
02 14Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 3Withdrawn by Holder
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
Certificate Number : R1-CEP 2010-142 - Rev 05
Status : Valid
Issue Date : 2023-08-23
Type : Chemical
Substance Number : 1181
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R1-CEP 2010-291 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2016-04-11
Type : Chemical
Substance Number : 1181
Certificate Number : R1-CEP 2002-168 - Rev 07
Status : Valid
Issue Date : 2019-09-25
Type : Chemical
Substance Number : 1181
Certificate Number : R1-CEP 2017-228 - Rev 00
Status : Valid
Issue Date : 2023-01-23
Type : Chemical
Substance Number : 1181
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : CEP 2004-251 - Rev 05
Status : Valid
Issue Date : 2024-05-14
Type : Chemical
Substance Number : 1181
Buprenorphine Hydrochloride, Process N
Certificate Number : CEP 2021-431 - Rev 02
Status : Valid
Issue Date : 2024-06-28
Type : Chemical
Substance Number : 1181
Buprenorphine Hydrochloride, Process II
Certificate Number : R0-CEP 2023-107 - Rev 00
Status : Valid
Issue Date : 2023-08-24
Type : Chemical
Substance Number : 1181
Certificate Number : CEP 2005-095 - Rev 01
Status : Valid
Issue Date : 2023-10-02
Type : Chemical
Substance Number : 1181
Buprenorphine Hydrochloride, Process II
Certificate Number : CEP 2024-011 - Rev 00
Status : Valid
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 1181
Certificate Number : R1-CEP 2007-325 - Rev 01
Status : Valid
Issue Date : 2022-10-14
Type : Chemical
Substance Number : 1181
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 CEP of the European Pharmacopoeia monograph is often referred to as a SUBOXONE Certificate of Suitability (COS). The purpose of a SUBOXONE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of SUBOXONE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of SUBOXONE to their clients by showing that a SUBOXONE CEP has been issued for it. The manufacturer submits a SUBOXONE CEP (COS) as part of the market authorization procedure, and it takes on the role of a SUBOXONE CEP holder for the record. Additionally, the data presented in the SUBOXONE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the SUBOXONE DMF.
A SUBOXONE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. SUBOXONE CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of SUBOXONE suppliers with CEP (COS) on PharmaCompass.
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