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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 Reference Price

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L","customerCountry":"JAPAN","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"150","totalValueFC":"14849.9","currency":"USD","unitRateINR":12342,"date":"18-Jan-2024","totalValueINR":"1234200","totalValueInUsd":"14849.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"6837050","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"206, ERIC HOUSE, 16TH ROAD,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710786600,"product":"BUPRENORPHINE HCL (BASE CONTENT \/SUBSTANCE BUPRENORPHINE 0.232 KG) *F.NO: XVI\/4\/840\/TECH\/PSY\/2024","address":"PLOT NO.58-D,GOVT. INDL.ESTATE,","city":"MUMBAI ,MAHARASHTRA","supplier":"RUSAN PHARMA","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"BAGO GROUP","customerCountry":"ARGENTINA","quantity":"0.25","actualQuantity":"250","unit":"GMS","unitRateFc":"27","totalValueFC":"6431","currency":"USD","unitRateINR":2136.0160000000001,"date":"19-Mar-2024","totalValueINR":"534004","totalValueInUsd":"6431","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"8458456","productDescription":"API","marketType":"","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT NO.58-D,GOVT. INDL.ESTATE,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727289000,"product":"BUPRENORPHINE HYDROCHLORIDE BASIC SUBSTANCE \/CONTENT BUPRENORPHINE 6.496 KGS *FILE NO: POR\/EXP\/JUL 2024\/000021","address":"PLOT NO.58-D,GOVT. INDL.ESTATE,","city":"MUMBAI ,MAHARASHTRA","supplier":"RUSAN PHARMA","supplierCountry":"INDIA","foreign_port":"LISBON","customer":"I GEN LDA","customerCountry":"PORTUGAL","quantity":"7.00","actualQuantity":"7","unit":"KGS","unitRateFc":"9000","totalValueFC":"64880","currency":"EUR","unitRateINR":776718.14285714284,"date":"26-Sep-2024","totalValueINR":"5437027","totalValueInUsd":"64880","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4366097","productDescription":"API","marketType":"REGULATED MARKET","country":"PORTUGAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PLOT NO.58-D,GOVT. INDL.ESTATE,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731522600,"product":"HSN CODE : 29391100 ITEM CODE. 2021091 HARMLESS PHARMACEUTICAL BULK DRUG BUPRENORPHINE HYDROCHLORIDE PH. EUR","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"INDIA","foreign_port":"BRUSSELS","customer":"M\/S.","customerCountry":"BELGIUM","quantity":"42.68","actualQuantity":"42.68","unit":"KGS","unitRateFc":"10000","totalValueFC":"448885","currency":"EUR","unitRateINR":887548.98313027178,"date":"14-Nov-2024","totalValueINR":"37880590.6","totalValueInUsd":"448885","indian_port":"Bombay Air","hs_no":"29391100","bill_no":"5596179","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"ACME PLAZA, ANDHERI KURLA ROAD,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739125800,"product":"PHARMACEUTICAL RAW MATERIAL OF PHARMACEUTICAL GRADE : BUPRENORPHINE HCL USP","address":"66\/70;PRINCESS STREET","city":"MUMBAI, ,MAHARASHTRA","supplier":"MICRO ORGO CHEM","supplierCountry":"INDIA","foreign_port":"ISLAMABAD - ISLAMABA","customer":"HABIB METROPOLITAN BANK ","customerCountry":"PAKISTAN","quantity":"0.24","actualQuantity":"241.44","unit":"GMS","unitRateFc":"25","totalValueFC":"5919.9","currency":"USD","unitRateINR":2132.2945659377074,"date":"10-Feb-2025","totalValueINR":"514821.2","totalValueInUsd":"5919.9","indian_port":"Bombay Air","hs_no":"29391100","bill_no":"8047383","productDescription":"API","marketType":"","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"66\/70;PRINCESS STREET, MUMBAI, ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1683743400,"product":"BUPRENORPHINE HYDROCHLORIDE","address":"SADODAY GYAN GROUND FLOOR,OPP NA DT NELSON SQUARE NAGPUR","city":"NAGPUR","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"CZECH REPUBLIC","foreign_port":"PRAGUE RUZYNE","customer":"ZIM LABORATORIES","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.03","unit":"KGS","unitRateFc":"18000","totalValueFC":"542.1","currency":"USD","unitRateINR":"1486800","date":"11-May-2023","totalValueINR":"44604","totalValueInUsd":"542.1","indian_port":"BOMBAY AIR","hs_no":"29391100","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"Czech Republic","selfForZScoreResived":"Pharma Grade","supplierPort":"PRAGUE RUZYNE","supplierAddress":"","customerAddress":"SADODAY GYAN GROUND FLOOR,OPP NA DT NELSON SQUARE NAGPUR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707157800,"product":"BUPRENORPHINE HCL USP (BUPRENORPHINE HYDROCHLORIDE) (CBN NOP\/IMP-10024\/2024 DT.15.01.2024)","address":"221, GOREGAON-MULUND LINK ROAD,","city":"BHANDUP WEST, MUMBAI","supplier":"M\/S. MACLARAN SMITH LIMITED","supplierCountry":"UNITED KINGDOM","foreign_port":"EDINBURGH","customer":"RUBICON RESEARCH","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"12000","totalValueFC":"121411.8","currency":"USD","unitRateINR":"1007400","date":"06-Feb-2024","totalValueINR":"10074000","totalValueInUsd":"121411.8","indian_port":"Bombay Air","hs_no":"29391100","bill_no":"9999742","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"EDINBURGH","supplierAddress":"10 WHEATFIELD ROADEDINBURGH EH11 2QAUNITED KINGDOM GB","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719426600,"product":"BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HCL USP) (CBN CERT NO. P\/IMP-10087\/2024 DTD. 12.02.2024)","address":"221, GOREGAON-MULUND LINK ROAD,","city":"BHANDUP WEST, MUMBAI","supplier":"VERANOVA","supplierCountry":"UNITED KINGDOM","foreign_port":"EDINBURGH","customer":"RUBICON RESEARCH","customerCountry":"INDIA","quantity":"6.80","actualQuantity":"6.8","unit":"KGS","unitRateFc":"12000","totalValueFC":"82402.1","currency":"USD","unitRateINR":"1011600","date":"27-Jun-2024","totalValueINR":"6878880","totalValueInUsd":"82402.1","indian_port":"Bombay Air","hs_no":"29391100","bill_no":"4207532","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"EDINBURGH","supplierAddress":"10 WHEATFIELD ROADEDINBURGH EH11 2QAUNITED KINGDOM GB","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734287400,"product":"BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE USP) BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE USP)","address":"221, GOREGAON-MULUND LINK ROAD,","city":"BHANDUP WEST, MUMBAI","supplier":"VERANOVA","supplierCountry":"UNITED KINGDOM","foreign_port":"GLASGOW","customer":"RUBICON RESEARCH LIMITED","customerCountry":"INDIA","quantity":"61.73","actualQuantity":"61.732","unit":"KGS","unitRateFc":"11500","totalValueFC":"715607.9","currency":"USD","unitRateINR":"984975","date":"16-Dec-2024","totalValueINR":"60804476.7","totalValueInUsd":"715607.9","indian_port":"Bombay Air","hs_no":"29391100","bill_no":"7276307","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"GLASGOW","supplierAddress":"10 WHEATFIELD ROAD EDINBURGH EH11 2QA UNITED KINGDOM GB","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"}]
    21-Jan-2021
    10-Feb-2025
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    API Imports and Exports

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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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    DOSAGE - IMPLANT;IMPLANTATION - EQ 80MG BASE/...DOSAGE - IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT

    USFDA APPLICATION NUMBER - 204442

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    DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG...DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE

    USFDA APPLICATION NUMBER - 205637

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    DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG...DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE

    USFDA APPLICATION NUMBER - 205637

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    DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG B...DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE

    USFDA APPLICATION NUMBER - 205637

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    DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0...DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20733

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    DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2...DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20733

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    DOSAGE - FILM;BUCCAL - EQ 0.075MG BASE

    USFDA APPLICATION NUMBER - 207932

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    DOSAGE - FILM;BUCCAL - EQ 0.15MG BASE

    USFDA APPLICATION NUMBER - 207932

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    DOSAGE - FILM;BUCCAL - EQ 0.3MG BASE

    USFDA APPLICATION NUMBER - 207932

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    DOSAGE - FILM;BUCCAL - EQ 0.45MG BASE

    USFDA APPLICATION NUMBER - 207932

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    DOSAGE - FILM;BUCCAL - EQ 0.6MG BASE

    USFDA APPLICATION NUMBER - 207932

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    DOSAGE - FILM;BUCCAL - EQ 0.75MG BASE

    USFDA APPLICATION NUMBER - 207932

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    DOSAGE - FILM;BUCCAL - EQ 0.9MG BASE

    USFDA APPLICATION NUMBER - 207932

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    DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BA...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE

    USFDA APPLICATION NUMBER - 22410

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    DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE

    USFDA APPLICATION NUMBER - 22410

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    DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE

    USFDA APPLICATION NUMBER - 22410

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    DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

    USFDA APPLICATION NUMBER - 22410

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    ABOUT THIS PAGE

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

    Buprenorphine Hydrochloride manufacturers, exporters & distributors 1

    88

    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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