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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 21 USDMF, 16 CEP/COS, 2 JDMF, 6 EU WC, 25 NDC API, 20 Listed Suppliers, $ API Reference Price

36 API Suppliers
21 USDMF
16 CEP/COS
2 JDMF
6 EU WC
25 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

171 FDF Dossiers, 99 FDA Orange Book, 37 Europe, 22 Canada, 4 South Africa, 9 Listed Dossiers

171 FDF Dossiers
99 FDA Orange Book
37 Europe
22 Canada
4 South Africa
9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT, FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE, FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE, TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;BUCCAL - EQ 0.075MG BASE, FILM;BUCCAL - EQ 0.15MG BASE, FILM;BUCCAL - EQ 0.3MG BASE, FILM;BUCCAL - EQ 0.45MG BASE, FILM;BUCCAL - EQ 0.6MG BASE, FILM;BUCCAL - EQ 0.75MG BASE, FILM;BUCCAL - EQ 0.9MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

drugProductComposition
INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT
FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE
FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE
FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE
TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FILM;BUCCAL - EQ 0.075MG BASE
FILM;BUCCAL - EQ 0.15MG BASE
FILM;BUCCAL - EQ 0.3MG BASE
FILM;BUCCAL - EQ 0.45MG BASE
FILM;BUCCAL - EQ 0.6MG BASE
FILM;BUCCAL - EQ 0.75MG BASE
FILM;BUCCAL - EQ 0.9MG BASE
FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE
FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE
FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE
FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem, 6 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 5 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 11 Actylis, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 6 DFE Pharma, 3 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 1 Lubrizol Life Science Health, 19 Microlex e.U, 1 NEWEDGE Overseas, 2 Nippon Fine Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 26 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

relatedExcipients
1 Minakem
6 Rochem International Inc
17 SPI Pharma
2 Seqens
5 DKSH
2 Jai Radhe Sales
1 Pharm-RX Chemical
7 Faran Shimi Pharmaceutical
8 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
15 Gangwal Healthcare
3 Nanjing Well Pharmaceutical
2 Pfanstiehl
1 ACG Worldwide
11 Actylis
2 Alcedo Pharmachem
9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
23 BASF
1 Bioplus Life Sciences
10 Corel Pharma Chem
6 DFE Pharma
3 Finar
8 Gangwal Chemicals
5 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
37 Kerry
4 Kima Chemical
6 Lonza Capsugel
1 Lubrizol Life Science Health
19 Microlex e.U
1 NEWEDGE Overseas
2 Nippon Fine Chemical
2 Nomisma Healthcare
3 Novo Excipients
4 Pharmatrans-Sanaq
8 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
26 Roquette
7 Seppic
7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
10 Sigachi Industries
3 The Dow Chemical Company
2 Ulanqab Kema New Material
1 Valens Pharmachem
3 Vasa Pharmachem
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

96 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 45 Direct Compression, 35 Thickeners and Stabilizers, 35 Disintegrants & Superdisintegrants, 30 Controlled & Modified Release, 27 Taste Masking, 26 Granulation, 22 Co-Processed Excipients, 21 Solubilizers, 20 Chewable & Orodispersible Aids, 18 Lubricants & Glidants, 15 Parenteral, 13 Topical, 13 Film Formers & Plasticizers, 6 Emulsifying Agents, 6 Rheology Modifiers, 6 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 54 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
54 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 8 Finished Drug Prices

globalSalesInformation
3 US Medicaid Prescriptions
8 Finished Drug Prices

MARKET PLACE

8 APIs, 4 FDF Dossiers

marketPlace
8 APIs
4 FDF Dossiers

PATENTS & EXCLUSIVITIES

102 US Patents

patents
102 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 1 USP , 4 Others

otherSolutions
2 EDQM
1 USP
4 Others

Temad Buprenorphine Hydrochloride

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 21,460

MARKET PLACE

API

FDF

7INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

171

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

4DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

102

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

267,749,652

Annual Reports (USD Million)

Finished Drug Prices

308 RELATED EXCIPIENT COMPANIES

499EXCIPIENTS BY APPLICATIONS

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

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 Formula	C₂₉H₄₂ClNO₄
Molecular Weight	504.1 g/mol
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 Å²
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

4 Drug and Medication Information

4.1 Drug Information

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

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

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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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

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

USFDA APPLICATION NUMBER - 204442

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

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

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

USFDA APPLICATION NUMBER - 205637

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

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

DOSAGE - FILM;BUCCAL - EQ 0.075MG BASE