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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
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
Molecular Weight | 504.1 g/mol |
---|---|
Molecular Formula | C29H42ClNO4 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 5 |
Exact Mass | 503.2802365 g/mol |
Monoisotopic Mass | 503.2802365 g/mol |
Topological Polar Surface Area | 62.2 Ų |
Heavy Atom Count | 35 |
Formal Charge | 0 |
Complexity | 869 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 6 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Buprenorphine hydrochloride |
Drug Label | Buprenorphine 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 Ingredient | Buprenorphine hydrochloride |
Dosage Form | Injectable; Tablet |
Route | Sublingual; Injection |
Strength | eq 2mg base; eq 0.3mg base/ml; eq 8mg base |
Market Status | Prescription |
Company | Hospira; Ethypharm; Luitpold; Eurohlth Intl; Roxane; Barr |
2 of 2 | |
---|---|
Drug Name | Buprenorphine hydrochloride |
Drug Label | Buprenorphine 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 Ingredient | Buprenorphine hydrochloride |
Dosage Form | Injectable; Tablet |
Route | Sublingual; Injection |
Strength | eq 2mg base; eq 0.3mg base/ml; eq 8mg base |
Market Status | Prescription |
Company | Hospira; Ethypharm; Luitpold; Eurohlth Intl; Roxane; Barr |
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
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.)
N07BC01
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-26
Pay. Date : 2012-11-30
DMF Number : 19109
Submission : 2006-01-12
Status : Active
Type : II
Certificate Number : R1-CEP 2002-168 - Rev 07
Issue Date : 2019-09-25
Type : Chemical
Substance Number : 1181
Status : Valid
Registration Number : 218MF11027
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2006-12-28
Latest Date of Registration :
NDC Package Code : 12707-035
Start Marketing Date : 2017-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ROW |
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-23
Pay. Date : 2012-11-23
DMF Number : 23683
Submission : 2010-04-05
Status : Active
Type : II
Certificate Number : R1-CEP 2010-142 - Rev 05
Issue Date : 2023-08-23
Type : Chemical
Substance Number : 1181
Status : Valid
NDC Package Code : 51634-0608
Start Marketing Date : 2017-07-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Date of Issue : 2018-01-09
Valid Till : 2019-01-09
Written Confirmation Number : 665/131411
Address of the Firm :
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
Issue Date : 2016-04-11
Type : Chemical
Substance Number : 1181
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7099
Submission : 1987-08-06
Status : Active
Type : II
Certificate Number : R1-CEP 2017-228 - Rev 00
Issue Date : 2023-01-23
Type : Chemical
Substance Number : 1181
Status : Valid
Date of Issue : 2025-02-11
Valid Till : 2027-06-09
Written Confirmation Number : WC-0278
Address of the Firm :
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-30
DMF Number : 19109
Submission : 2006-01-12
Status : Active
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 : Active
Type : II
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 : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7099
Submission : 1987-08-06
Status : Active
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 : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12412
Submission : 1997-03-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7684
Submission : 1988-09-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-10-26
Pay. Date : 2012-12-03
DMF Number : 21060
Submission : 2007-11-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-14
Pay. Date : 2020-01-09
DMF Number : 22856
Submission : 2009-08-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7923
Submission : 1989-01-23
Status : Inactive
Type : II
Certificate Number : R1-CEP 2002-168 - Rev 07
Status : Valid
Issue Date : 2019-09-25
Type : Chemical
Substance Number : 1181
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 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 06
Status : Valid
Issue Date : 2025-02-10
Type : Chemical
Substance Number : 1181
Certificate Number : R1-CEP 2009-346 - Rev 01
Status : Valid
Issue Date : 2017-02-20
Type : Chemical
Substance Number : 1181
Certificate Number : R1-CEP 2013-048 - Rev 00
Status : Valid
Issue Date : 2021-05-04
Type : Chemical
Substance Number : 1181
Certificate Number : R0-CEP 2010-166 - Rev 01
Status : Expired
Issue Date : 2014-09-04
Type : Chemical
Substance Number : 1181
Registration Number : 218MF11027
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2006-12-28
Latest Date of Registration : 2013-11-11
Registration Number : 231MF10001
Registrant's Address : 206, Eric House, 16th Road, Chembur, Mumbai-400071. INDIA
Initial Date of Registration : 2019-01-10
Latest Date of Registration : 2019-01-10
Date of Issue : 2018-01-09
Valid Till : 2019-01-09
Written Confirmation Number : 665/131411
Address of the Firm : 28th km of Karaj Makhsous Road, Tehran, Iran
Buprenorphine Hydrochloride Ph Eur/BP/USP
Date of Issue : 2025-02-11
Valid Till : 2027-06-09
Written Confirmation Number : WC-0278
Address of the Firm : Plot No.6406, 6407 & 6411, GIDC Estate, Ankleshwar-393002, Dist- Bharuch
Buprenorphine Hydrochloride BP/EP/USP/IP
Date of Issue : 2022-08-08
Valid Till : 2024-07-08
Written Confirmation Number : WC-0174
Address of the Firm : Plot No. 6,7,8,20 & 24, MIDC Industrial Area, Post Kulgaon, Badlapur, Dist. Than...
Buprenorphine Hydrochloride BP/Ph.Eur.
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm : Plot No. 24/2, & 25, Phase -IV, GIDC Industrial Zone, At & Post - Panoli, Dist.-...
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Subutex sublingual 2 mg
Dosage Form : SLT
Dosage Strength : 2mg
Packaging : 7X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Subutex sublingual 8 mg
Dosage Form : SLT
Dosage Strength : 8mg
Packaging : 7X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Suboxone 2 mg
Dosage Form : SLT
Dosage Strength : 2mg
Packaging : 7X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Suboxone 8 mg
Dosage Form : SLT
Dosage Strength : 8mg
Packaging : 7X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Dosage Form : Capsule
Grade : Oral
Brand Name : Sodium Stearyl Fumarate G...
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate is used as a lubricant in OSDs to reduce the friction and the adhesion. It also provides tablet strength & disintegration.
Pharmacopoeia Ref : USP, EP, ICH, Q7GMP
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate
Excipients by Applications
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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.
A Buprenorphine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Buprenorphine Hydrochloride, including repackagers and relabelers. The FDA regulates Buprenorphine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Buprenorphine Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Buprenorphine Hydrochloride supplier is an individual or a company that provides Buprenorphine Hydrochloride active pharmaceutical ingredient (API) or Buprenorphine Hydrochloride finished formulations upon request. The Buprenorphine Hydrochloride suppliers may include Buprenorphine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Buprenorphine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Buprenorphine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Buprenorphine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Buprenorphine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Buprenorphine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Buprenorphine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Buprenorphine Hydrochloride USDMF includes data on Buprenorphine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Buprenorphine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Buprenorphine Hydrochloride suppliers with USDMF on PharmaCompass.
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 Buprenorphine Hydrochloride Drug Master File in Japan (Buprenorphine Hydrochloride JDMF) empowers Buprenorphine Hydrochloride 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 Buprenorphine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Buprenorphine Hydrochloride 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 Buprenorphine Hydrochloride suppliers with JDMF on PharmaCompass.
A Buprenorphine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Buprenorphine Hydrochloride Certificate of Suitability (COS). The purpose of a Buprenorphine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Buprenorphine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Buprenorphine Hydrochloride to their clients by showing that a Buprenorphine Hydrochloride CEP has been issued for it. The manufacturer submits a Buprenorphine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Buprenorphine Hydrochloride CEP holder for the record. Additionally, the data presented in the Buprenorphine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Buprenorphine Hydrochloride DMF.
A Buprenorphine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Buprenorphine Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Buprenorphine Hydrochloride written confirmation (Buprenorphine Hydrochloride WC) is an official document issued by a regulatory agency to a Buprenorphine Hydrochloride manufacturer, verifying that the manufacturing facility of a Buprenorphine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Buprenorphine Hydrochloride APIs or Buprenorphine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Buprenorphine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Buprenorphine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
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 Buprenorphine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Buprenorphine Hydrochloride API and other APIs are published in this directory by the FDA.
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 Buprenorphine Hydrochloride 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.
The NDC directory also contains data on finished compounded human drug products that contain Buprenorphine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Buprenorphine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Buprenorphine Hydrochloride suppliers with NDC on PharmaCompass.
Buprenorphine Hydrochloride 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 Buprenorphine Hydrochloride 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 Buprenorphine Hydrochloride GMP manufacturer or Buprenorphine Hydrochloride GMP API supplier for your needs.
A Buprenorphine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Buprenorphine Hydrochloride's compliance with Buprenorphine Hydrochloride specifications and serves as a tool for batch-level quality control.
Buprenorphine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Buprenorphine Hydrochloride 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.
Buprenorphine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Buprenorphine Hydrochloride EP), Buprenorphine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Buprenorphine Hydrochloride USP).