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Chemistry

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Also known as: Buprenorphine hydrochloride, Ncgc00247733-01, Dsstox_cid_28831, Dsstox_rid_83100, Dsstox_gsid_48905, Tox21_112899
Molecular Formula
C29H42ClNO4
Molecular Weight
504.1  g/mol
InChI Key
UAIXRPCCYXNJMQ-CHLZSUIASA-N

Buprenorphine Hydrochloride
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.
1 2D Structure

Buprenorphine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1S,2S,6R,14R,16R)-5-(cyclopropylmethyl)-16-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-15-methoxy-13-oxa-5-azahexacyclo[13.2.2.12,8.01,6.02,14.012,20]icosa-8(20),9,11-trien-11-ol;hydrochloride
2.1.2 InChI
InChI=1S/C29H41NO4.ClH/c1-25(2,3)26(4,32)20-15-27-10-11-29(20,33-5)24-28(27)12-13-30(16-17-6-7-17)21(27)14-18-8-9-19(31)23(34-24)22(18)28;/h8-9,17,20-21,24,31-32H,6-7,10-16H2,1-5H3;1H/t20-,21-,24-,26+,27-,28+,29?;/m1./s1
2.1.3 InChI Key
UAIXRPCCYXNJMQ-CHLZSUIASA-N
2.1.4 Canonical SMILES
CC(C)(C)C(C)(C1CC23CCC1(C4C25CCN(C3CC6=C5C(=C(C=C6)O)O4)CC7CC7)OC)O.Cl
2.1.5 Isomeric SMILES
C[C@]([C@H]1C[C@@]23CCC1([C@H]4[C@@]25CCN([C@@H]3CC6=C5C(=C(C=C6)O)O4)CC7CC7)OC)(C(C)(C)C)O.Cl
2.2 Synonyms
2.2.1 MeSH Synonyms

1. 6029 M

2. 6029-m

3. 6029m

4. Buprenex

5. Buprenorphine

6. Buprenorphine Hydrochloride

7. Buprex

8. Hydrochloride, Buprenorphine

9. Prefin

10. Rx 6029 M

11. Rx-6029-m

12. Rx6029m

13. Subutex

14. Temgsic

15. Temgesic

2.2.2 Depositor-Supplied Synonyms

1. Buprenorphine Hydrochloride

2. Ncgc00247733-01

3. Dsstox_cid_28831

4. Dsstox_rid_83100

5. Dsstox_gsid_48905

6. Tox21_112899

7. Cas-53152-21-9

2.3 Create Date
2006-12-27
3 Chemical and Physical Properties
Molecular Weight 504.1 g/mol
Molecular Formula C29H42ClNO4
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count5
Rotatable Bond Count5
Exact Mass503.2802365 g/mol
Monoisotopic Mass503.2802365 g/mol
Topological Polar Surface Area62.2 Ų
Heavy Atom Count35
Formal Charge0
Complexity869
Isotope Atom Count0
Defined Atom Stereocenter Count6
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameBuprenorphine hydrochloride
Drug LabelBuprenorphine hydrochloride sublingual tablets contains buprenorphine HCl.Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Buprenorphine is a Schedule III narcotic under the Controlled Subst...
Active IngredientBuprenorphine hydrochloride
Dosage FormInjectable; Tablet
RouteSublingual; Injection
Strengtheq 2mg base; eq 0.3mg base/ml; eq 8mg base
Market StatusPrescription
CompanyHospira; Ethypharm; Luitpold; Eurohlth Intl; Roxane; Barr

2 of 2  
Drug NameBuprenorphine hydrochloride
Drug LabelBuprenorphine hydrochloride sublingual tablets contains buprenorphine HCl.Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Buprenorphine is a Schedule III narcotic under the Controlled Subst...
Active IngredientBuprenorphine hydrochloride
Dosage FormInjectable; Tablet
RouteSublingual; Injection
Strengtheq 2mg base; eq 0.3mg base/ml; eq 8mg base
Market StatusPrescription
CompanyHospira; Ethypharm; Luitpold; Eurohlth Intl; Roxane; Barr

4.2 Drug Indication

Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.


Treatment of opioid dependence


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Analgesics, Opioid

Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)


Narcotic Antagonists

Agents inhibiting the effect of narcotics on the central nervous system. (See all compounds classified as Narcotic Antagonists.)


Narcotics

Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS. (See all compounds classified as Narcotics.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Partial Opioid Agonists [MoA]; Partial Opioid Agonist [EPC]
5.3 ATC Code

N07BC01


API SUPPLIERS

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01

Veranova

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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02

Faran Shimi Pharmaceutical

Iran

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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03

Noramco

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothNoramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

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04

SCI Pharmtech

Taiwan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothSCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.

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Temad Co

Iran

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothTemad- We think of world-class quality.

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EUROAPI

France

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Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Sanofi

France

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Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Aspen API

Netherlands

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Rusan Pharma

India

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Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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Tenatra Chemie

India

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Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Listed Suppliers

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01

Veranova

U.S.A
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Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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Buprenorphine Hydrochloride

About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...

Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle. Macfarlan Smith Limited is trading as Veranova in the United Kingdom.
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02

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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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Buprenorphine Hydrochloride

About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.
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03

Noramco

U.S.A
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Virtual BoothNoramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

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Buprenorphine Hydrochloride

About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...

Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and manufacturing, Noramco offers services like supply-chain integration for high-purity controlled substances, efficient routes to APIs, analytical data, stability studies, regulatory help, formulation-friendly particle size grades, extended technical packages, DEA-compliant security and production capacity from kilos to multi-ton supply. Noramco also offers world-class supply security for controlled substances, from Schedule I to Schedule III.
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SCI Pharmtech

Taiwan
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Virtual BoothSCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.

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Buprenorphine Hydrochloride

About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...

SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and production facilities are fully equipped, and our experienced team ensures high-quality results. We work with pharmaceutical and specialty companies around the world to create important intermediates, APIs, and tailored products. Our facility meets FDA, EDQM, and Taiwan TFDA standards for versatile, large-scale manufacturing, ensuring reliable and compliant production processes.
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Temad Co

Iran
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Buprenorphine Hydrochloride

About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...

Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Middle East. Apart from complying with Iranian GMP regulations, Temad has acquired the national & international standards of API manufacturing such as ISO 9001/14001/17025/45001 and OHSAS 18001. It currently manufactures more than 115 pharmaceutical products, including narcotics and non-narcotics, in accordance with GMP and WHO standards and regulations. Temad exports its products to 45 countries worldwide.
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EUROAPI

France
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Buprenorphine Hydrochloride

About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...

EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our CDMO activities. Taking action for health by enabling access to essential therapies inspires our 3,650 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries.
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Rusan Pharma

India
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Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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Buprenorphine Hydrochloride

About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...

Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formulations, in the area of controlled substances. Our facilities are GMP-approved by Health Canada, EU, TGA, ANVISA, PIC/S, WHO, Russia & SAHPRA. We have CEP approval for various APIs such as Buprenorphine, Fentanyl, Naltrexone, Methadone, Bisoprolol & we also manufacture Naloxone, Nalbuphine, Nalmefene, Apomorphine, Efflornithine & Sodium Oxybate. We also develop & manufacture various transdermal patches & long-acting formulations such as depot injections & Implants.
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Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Buprenorphine Hydrochloride

About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Chemie Private Limited (TCPL) was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India.
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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Buprenorphine Hydrochloride

About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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10

Biotechnica DWC

Algeria
Pharmacy Expo
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Biotechnica DWC

Algeria
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Buprenorphine Hydrochloride

About the Company : BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies al...

BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies all over the world. Biotechnica is an integrated global solution provider from design to implementation of industrial projects in the areas of Pharmaceuticals,Agri-food ,Cosmetics and Nutrition. With more than 25 years of experience in the assembly of plants, particularly in the pharmaceutical sector, we accompany our customers in the various stages of their projects – E-CTD Dossieers – Raw Materiels – Equipements – Accessories – Packaging – Distribution.
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INDL.ESTATE,CHARKOP,KANDIVALI,","city":"MUMBAI ,MAHARASHTRA","supplier":"RUSAN PHARMA","supplierCountry":"INDIA","foreign_port":"TEHRAN","customer":"DAROU DARMAN PARS.,","customerCountry":"IRAN","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"13050","totalValueFC":"380322","currency":"USD","unitRateINR":940250.69999999995,"date":"26-Aug-2021","totalValueINR":"28207521","totalValueInUsd":"380322","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"4137761","productDescription":"API","marketType":"","country":"IRAN","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"PLOT NO.58-D,GOVT. INDL.ESTATE,CHARKOP,KANDIVALI,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1629916200,"product":"BUPRENORPHINE HYDROCHLORIDE USP (BASIC S","address":"PLOT NO.58-D,GOVT. INDL.ESTATE,CHARKOP,KANDIVALI,","city":"MUMBAI ,MAHARASHTRA","supplier":"RUSAN PHARMA","supplierCountry":"INDIA","foreign_port":"TEHRAN","customer":"DAROU DARMAN PARS.,","customerCountry":"IRAN","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"13000","totalValueFC":"381029.6","currency":"EUR","unitRateINR":942000,"date":"26-Aug-2021","totalValueINR":"28260000","totalValueInUsd":"381029.6","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"4136692","productDescription":"API","marketType":"","country":"IRAN","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"PLOT NO.58-D,GOVT. INDL.ESTATE,CHARKOP,KANDIVALI,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1630261800,"product":"BUPRENORPHINE HYDROCHLORIDE EP [EXPORT P","address":"206, ERIC HOUSE, 16TH ROAD,CHEMBUR,","city":"MUMBAI, MAHARASHTRA.","supplier":"PIONEER AGRO EXTRACTS","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"S.H.P.","customerCountry":"ALGERIA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"45.7","totalValueFC":"4503.3","currency":"USD","unitRateINR":3340,"date":"30-Aug-2021","totalValueINR":"334000","totalValueInUsd":"4503.3","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"4232069","productDescription":"API","marketType":"","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"206, ERIC HOUSE, 16TH ROAD,CHEMBUR,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1635273000,"product":"BUPRENORPHINE HYDROCHLORIDE EP (BASIC SU","address":"PLOT NO.58-D,GOVT. INDL.ESTATE,CHARKOP,KANDIVALI,","city":"MUMBAI ,MAHARASHTRA","supplier":"RUSAN PHARMA","supplierCountry":"INDIA","foreign_port":"SHENZHEN","customer":"SHENZHEN SCIENCARE MEDICAL INDUSTRI","customerCountry":"CHINA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"32000","totalValueFC":"31610.4","currency":"USD","unitRateINR":2368000,"date":"27-Oct-2021","totalValueINR":"2368000","totalValueInUsd":"31610.4","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"5614891","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"PLOT NO.58-D,GOVT. INDL.ESTATE,CHARKOP,KANDIVALI,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1642530600,"product":"BUPRENORPHINE HYDROCHLORIDE EP (BASIC SU","address":"PLOT NO 58- D GOVT. INDUSTRIAL ESTA CHARKOP KANDIVALI","city":"MUMBAI","supplier":"RUSAN PHARMA","supplierCountry":"INDIA","foreign_port":"LONDON - HEATHROW","customer":"SUMMIT VETERINARY PHARMACEUTICALS","customerCountry":"UNITED KINGDOM","quantity":"0.30","actualQuantity":"300","unit":"GMS","unitRateFc":"24","totalValueFC":"7987.3","currency":"EUR","unitRateINR":1983.3333333333333,"date":"19-Jan-2022","totalValueINR":"595000","totalValueInUsd":"7987.3","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"7588915","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"PLOT NO 58- D GOVT. INDUSTRIAL ESTA CHARKOP KANDIVALI, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649701800,"product":"BUPRENORPHINE HYDROCHLORIDE EP [EXPORT P","address":"206, ERIC HOUSE, 16TH ROAD, CHEMBUR,","city":"MUMBAI, MAHARASHTRA.","supplier":"SANVIN LABORATORIES PVT LTD","supplierCountry":"INDIA","foreign_port":"TOKYO","customer":"F & C. LTD.","customerCountry":"JAPAN","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"150000","totalValueFC":"14884.2","currency":"USD","unitRateINR":11230000,"date":"12-Apr-2022","totalValueINR":"1123000","totalValueInUsd":"14884.2","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"9638711","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"206, ERIC HOUSE, 16TH ROAD, CHEMBUR,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1664389800,"product":"BUPRENORPHINE HYDROCHLORIDE EP(BASIC SUB","address":"PLOT NO 58- D GOVT. 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INDUSTRIAL ESTA CHARKOP KANDIVALI, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677695400,"product":"BUPRENORPHINE HYDROCHLORIDE EP [EXPORT P","address":"206, ERIC HOUSE, 16TH ROAD, CHEMBUR,","city":"MUMBAI, MAHARASHTRA.","supplier":"PIONEER AGRO INDUSTRIES SANVIN LABORATORIES PRIVAT","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"L. L. F. R. 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AG","customerCountry":"JAPAN","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"150","totalValueFC":"14810.3","currency":"USD","unitRateINR":12770.799999999999,"date":"28-Jan-2025","totalValueINR":"1277080","totalValueInUsd":"14810.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"7655759","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"206, ERIC HOUSE, 16TH ROAD,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1640629800,"product":"(FOC) - BUPRENORPHINE HCL FINE MILLED (US) - 2127X001 - 2127X002 (100 GRAMS)","address":"NO.54\/1, BOODIHAL,,NELAMANGALA,","city":"BENGALURU,KARNATAKA","supplier":"M\/S. 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08-Jan-2021
28-Jan-2025
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

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API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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Europe

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01

Ethypharm

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Norway

Buprenorphine Hydrochloride

Brand Name : Espranor

Dosage Form : Lyofilisattablett

Dosage Strength : 8 mg

Packaging : Endose blister pack 7 1item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Ethypharm

02

Ethypharm

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Norway

Buprenorphine Hydrochloride

Brand Name : Espranor

Dosage Form : Lyofilisattablett

Dosage Strength : 2 mg

Packaging : Endose blister pack 7 1item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Ethypharm

03

Pharmacy Expo
Not Confirmed
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Pharmacy Expo
Not Confirmed

buprenorphine hydrochloride

Brand Name : Buprenorphine Bluefish

Dosage Form : SUBLINGUAL TABLET

Dosage Strength : 8 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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04

GL Pharma GmbH,

Austria
Pharmacy Expo
Not Confirmed
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GL Pharma GmbH,

Austria
arrow
Pharmacy Expo
Not Confirmed

buprenorphine hydrochloride

Brand Name : Buprenorphine GL Pharma

Dosage Form : SUBLINGUAL TABLET

Dosage Strength : 4 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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05

Pharmacy Expo
Not Confirmed
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Pharmacy Expo
Not Confirmed

Several substances refer to content

Brand Name : Suboxone

Dosage Form : SUBLINGUAL TABLET

Dosage Strength : 2 MG / 0.5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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06

Pharmacy Expo
Not Confirmed
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Pharmacy Expo
Not Confirmed

Several substances refer to content

Brand Name : Suboxone

Dosage Form : SUBLINGUAL TABLET

Dosage Strength : 8 MG / 2 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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07

Pharmacy Expo
Not Confirmed
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Pharmacy Expo
Not Confirmed

Several substances refer to content

Brand Name : Suboxone

Dosage Form : SUBLINGUAL TABLET

Dosage Strength : 16 MG / 4 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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08

Pharmacy Expo
Not Confirmed
arrow
arrow
Pharmacy Expo
Not Confirmed

buprenorphine hydrochloride

Brand Name : Buprenorphine Orifarm

Dosage Form : SUBLINGUAL TABLET

Dosage Strength : 2 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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09

Pharmacy Expo
Not Confirmed
arrow
arrow
Pharmacy Expo
Not Confirmed

buprenorphine hydrochloride

Brand Name : Buprenorphine Orifarm

Dosage Form : SUBLINGUAL TABLET

Dosage Strength : 8 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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10

Sandoz A / S,

Switzerland
Pharmacy Expo
Not Confirmed
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Sandoz A / S,

Switzerland
arrow
Pharmacy Expo
Not Confirmed

buprenorphine hydrochloride

Brand Name : Buprenorphine Sandoz

Dosage Form : SUBLINGUAL TABLET

Dosage Strength : 8 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - EQ 0.3MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18401

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ABOUT THIS PAGE

Looking for 53152-21-9 / Buprenorphine Hydrochloride API manufacturers, exporters & distributors?

Buprenorphine Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Buprenorphine Hydrochloride 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 Hydrochloride manufacturer or Buprenorphine Hydrochloride supplier for your needs.

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

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

API | Excipient name

Buprenorphine Hydrochloride

Synonyms

Ncgc00247733-01, Dsstox_cid_28831, Dsstox_rid_83100, Dsstox_gsid_48905, Tox21_112899, Cas-53152-21-9

Cas Number

53152-21-9

About Buprenorphine Hydrochloride

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.

BELBUCA Manufacturers

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

BELBUCA Suppliers

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

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

BELBUCA USDMF

A BELBUCA DMF (Drug Master File) is a document detailing the whole manufacturing process of BELBUCA active pharmaceutical ingredient (API) in detail. Different forms of BELBUCA DMFs exist exist since differing nations have different regulations, such as BELBUCA USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A BELBUCA DMF submitted to regulatory agencies in the US is known as a USDMF. BELBUCA USDMF includes data on BELBUCA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BELBUCA USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of BELBUCA suppliers with USDMF on PharmaCompass.

BELBUCA JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The BELBUCA Drug Master File in Japan (BELBUCA JDMF) empowers BELBUCA API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the BELBUCA JDMF during the approval evaluation for pharmaceutical products. At the time of BELBUCA JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of BELBUCA suppliers with JDMF on PharmaCompass.

BELBUCA CEP

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

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

BELBUCA WC

A BELBUCA written confirmation (BELBUCA WC) is an official document issued by a regulatory agency to a BELBUCA manufacturer, verifying that the manufacturing facility of a BELBUCA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BELBUCA APIs or BELBUCA finished pharmaceutical products to another nation, regulatory agencies frequently require a BELBUCA WC (written confirmation) as part of the regulatory process.

click here to find a list of BELBUCA suppliers with Written Confirmation (WC) on PharmaCompass.

BELBUCA NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing BELBUCA as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for BELBUCA API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture BELBUCA as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain BELBUCA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BELBUCA NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of BELBUCA suppliers with NDC on PharmaCompass.

BELBUCA GMP

BELBUCA Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

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

BELBUCA CoA

A BELBUCA CoA (Certificate of Analysis) is a formal document that attests to BELBUCA's compliance with BELBUCA specifications and serves as a tool for batch-level quality control.

BELBUCA CoA mostly includes findings from lab analyses of a specific batch. For each BELBUCA CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

BELBUCA may be tested according to a variety of international standards, such as European Pharmacopoeia (BELBUCA EP), BELBUCA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BELBUCA USP).

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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