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List of Certificates of Suitability (CEPs) for Buprenorphine Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 NORAMCO, LLC. Wilmington US (2)

02 MACFARLAN SMITH LIMITED Edinburgh GB (1)

03 RUSAN PHARMA LTD Mumbai IN (2)

04 TEVA CZECH INDUSTRIES S.R.O. Opava CZ (1)

05 AREVIPHARMA GMBH Radebeul DE (1)

06 CHR. OLESEN SYNTHESIS A/S Hvidovre DK (1)

07 N.V. ORGANON Oss NL (1)

08 PIONEER AGRO INDUSTRIES SANVIN LABORATORIES PRIVATE LIMITED Mumbai IN (1)

09 SIEGFRIED LTD. Zofingen CH (1)

10 SPECGX LLC Webster Groves US (1)

11 Tasmanian Alkaloids Pty Ltd Westbury AU (1)

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01 Buprenorphine (13)

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01 Australia (1)

02 Denmark (1)

03 Germany (1)

04 India (3)

05 Israel (1)

06 Switzerland (1)

07 U.S.A (4)

08 United Kingdom (1)

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01 Expired (1)

02 Valid (9)

03 Withdrawn by EDQM Failure to CEP procedure (1)

04 Withdrawn by Holder (2)

URL Supplier Web Content
R1-CEP 2008-041 - Rev 03
Valid
Chemical
2022-05-23
1180
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R1-CEP 2010-051 - Rev 01
Valid
Chemical
2017-01-20
1180
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R0-CEP 2021-098 - Rev 00
Valid
Chemical
2022-11-14
1180
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R1-CEP 2013-098 - Rev 00
Valid
Chemical
2021-06-24
1180
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CEP 2005-096 - Rev 01
Valid
Chemical
2023-10-02
1180
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R1-CEP 2007-324 - Rev 01
Valid
Chemical
2022-05-18
1180
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R1-CEP 1998-037 - Rev 03
Withdrawn by Holder
Chemical
2016-07-22
2018-10-11
1180
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Looking for 52485-79-7 / Buprenorphine API manufacturers, exporters & distributors?

Buprenorphine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Buprenorphine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Buprenorphine manufacturer or Buprenorphine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Buprenorphine manufacturer or Buprenorphine supplier.

PharmaCompass also assists you with knowing the Buprenorphine API Price utilized in the formulation of products. Buprenorphine API Price is not always fixed or binding as the Buprenorphine Price is obtained through a variety of data sources. The Buprenorphine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Buprenorphine

Synonyms

Temgesic, Probuphine, Buprenex, 52485-79-7, Buprenophine, Buprenorfina

Cas Number

52485-79-7

Unique Ingredient Identifier (UNII)

40D3SCR4GZ

About Buprenorphine

A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.

Buprenorphine Manufacturers

A Buprenorphine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Buprenorphine, including repackagers and relabelers. The FDA regulates Buprenorphine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Buprenorphine 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 Buprenorphine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Buprenorphine Suppliers

A Buprenorphine supplier is an individual or a company that provides Buprenorphine active pharmaceutical ingredient (API) or Buprenorphine finished formulations upon request. The Buprenorphine suppliers may include Buprenorphine API manufacturers, exporters, distributors and traders.

click here to find a list of Buprenorphine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Buprenorphine CEP

A Buprenorphine CEP of the European Pharmacopoeia monograph is often referred to as a Buprenorphine Certificate of Suitability (COS). The purpose of a Buprenorphine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Buprenorphine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Buprenorphine to their clients by showing that a Buprenorphine CEP has been issued for it. The manufacturer submits a Buprenorphine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Buprenorphine CEP holder for the record. Additionally, the data presented in the Buprenorphine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Buprenorphine DMF.

A Buprenorphine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Buprenorphine 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 Buprenorphine suppliers with CEP (COS) on PharmaCompass.

Buprenorphine Manufacturers | Traders | Suppliers

Buprenorphine Manufacturers, Traders, Suppliers 1
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Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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