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List of Drug Master Files (DMF) of Buprenorphine Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Buprenorphine
ORP-101
CAS 52485-79-7
Buprenorphine Hydrochloride
3-O-Methyl Norbuprenorphine
CAS 16196-70-6
CAS 78715-23-8
USDMF

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xyz-pharma-m-2024-09-09

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SCI PHARMTECH Buprenorphine

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xyz-pharma-m-2024-09-09

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Buprenorphine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

33 API Suppliers, 12 USDMF, 11 CEP/COS, 2 JDMF, 4 EU WC, 13 NDC API, 23 Listed Suppliers, $ API Reference Price

33 API Suppliers
12 USDMF
11 CEP/COS
2 JDMF
4 EU WC
13 NDC API
23 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

28 Drugs in Development

28 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

13 API Suppliers

13 API Suppliers

FINISHED DOSAGE FORMULATIONS

268 FDF Dossiers, 39 FDA Orange Book, 117 Europe, 6 Canada, 63 Australia, 7 South Africa, 36 Listed Dossiers

268 FDF Dossiers
39 FDA Orange Book
117 Europe
6 Canada
63 Australia
7 South Africa
36 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM, EXTENDED RELEASE;TRANSDERMAL - 10MCG/HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 15MCG/HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 20MCG/HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 5MCG/HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 7.5MCG/HR

FILM, EXTENDED RELEASE;TRANSDERMAL - 10MCG/HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 15MCG/HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 20MCG/HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 5MCG/HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 7.5MCG/HR

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 12 SPI Pharma, 2 Seqens, 1 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 18 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 28 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 4 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

58 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 24 Direct Compression, 24 Controlled & Modified Release, 17 Taste Masking, 15 Granulation, 14 Thickeners and Stabilizers, 12 Solubilizers, 12 Chewable & Orodispersible Aids, 10 Parenteral, 10 Lubricants & Glidants, 9 Co-Processed Excipients, 8 Film Formers & Plasticizers, 7 Topical, 6 Disintegrants & Superdisintegrants, 5 Empty Capsules, 5 API Stability Enhancers, 4 Emulsifying Agents, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Rheology Modifiers

58 Fillers, Diluents & Binders
42 Coating Systems & Additives
24 Direct Compression
24 Controlled & Modified Release
17 Taste Masking
15 Granulation
14 Thickeners and Stabilizers
12 Solubilizers
12 Chewable & Orodispersible Aids
10 Parenteral
10 Lubricants & Glidants
9 Co-Processed Excipients
8 Film Formers & Plasticizers
7 Topical
6 Disintegrants & Superdisintegrants
5 Empty Capsules
5 API Stability Enhancers
4 Emulsifying Agents
4 Vegetarian Capsules
2 Coloring Agents
1 Rheology Modifiers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 192 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
192 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 94 Finished Drug Prices

1 US Medicaid Prescriptions
94 Finished Drug Prices

MARKET PLACE

11 APIs, 5 FDF Dossiers

11 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

96 US Patents, 7 US Exclusivities, 7 Health Canada Patents

96 US Patents
7 US Exclusivities
7 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 20 Others

2 EDQM
1 USP
20 Others

$ API Ref.Price (USD/KG) : 15,127 Xls

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12 All

01 2Noramco

02 1Veranova

03 1Arevipharma

04 1Fujifilm Diosynth Biotechnologies

05 1Mallinckrodt Pharmaceuticals

06 2Siegfried AG

07 1Sun Pharmaceutical Industries Limited

08 2Tasmanian Alkaloids Pty Ltd

09 1Teva API

filter Subject Reset all filters

12 All

01 7BUPRENORPHINE

02 2BUPRENORPHINE BASE

03 1BUPRENORPHINE BASE (R371605) DRUG SUBSTANCE

04 1BUPRENORPHINE BASE DRUG SUBSTANCE

05 1BUPRENORPHINE BASE EP, CODE 3205

filter Country Reset all filters

12 All

01 2Australia

02 1Germany

03 1India

04 1Ireland

05 1Israel

06 2Switzerland

07 3U.S.A

08 1United Kingdom

filter Status Reset all filters

12 All

01 9Active

02 3Inactive

filter GDUFA DMF Review Reset all filters

12 All

01 9Complete

02 3Blank

Temad Buprenorphine

API Suppliers
USDMF
CEP/COS
JDMF
EU WC
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Noramco Llc

CPhI Worldwide, Milan

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

Contact Supplier

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Digital Content

Buprenorphine Base (r371605) Drug Substance

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-15

Pay. Date : 2012-11-23

DMF Number : 23684

Submission : 2010-04-05

Status : Active

Type : II

Product Web Link

Digital Content

02

Macfarlan Smith Ltd A Johnson Matthe...

CPhI Worldwide, Milan

Veranova: A CDMO that manages complexity with confidence.

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Digital Content

Buprenorphine

GDUFA

DMF Review : Complete

Rev. Date : 2013-11-08

Pay. Date : 2012-12-12

DMF Number : 26448

Submission : 2012-09-17

Status : Active

Type : II

Product Web Link

Digital Content

03

Noramco Llc

CPhI Worldwide, Milan

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

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Digital Content

Buprenorphine

GDUFA

DMF Review : Complete

Rev. Date : 2017-03-03

Pay. Date : 2016-09-08

DMF Number : 30762

Submission : 2016-08-04

Status : Active

Type : II

Product Web Link

Digital Content

04

Arevipharma Gmbh

USDMF

Formnext Forum

Not Confirmed

04

Arevipharma Gmbh

Formnext Forum

Not Confirmed

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Digital Content

Buprenorphine

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-23

Pay. Date : 2013-09-30

DMF Number : 27547

Submission : 2013-09-23

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

05

Diosynth Bv

USDMF

Formnext Forum

Not Confirmed

05

Diosynth Bv

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Not Confirmed

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Digital Content

Buprenorphine

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 8542

Submission : 1990-04-27

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Specgx Llc

USDMF

Formnext Forum

Not Confirmed

06

Specgx Llc

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Not Confirmed

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Digital Content

Buprenorphine Base Ep, Code 3205

GDUFA

DMF Review : Complete

Rev. Date : 2014-01-24

Pay. Date : 2012-11-27

DMF Number : 24928

Submission : 2012-05-02

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Siegfried Usa Llc

USDMF

Formnext Forum

Not Confirmed

07

Siegfried Usa Llc

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Not Confirmed

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Digital Content

Buprenorphine

GDUFA

DMF Review : Complete

Rev. Date : 2015-07-24

Pay. Date : 2015-03-06

DMF Number : 29091

Submission : 2015-03-02

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

08

Siegfried Ltd

USDMF

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Not Confirmed

08

Siegfried Ltd

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Digital Content

Buprenorphine

GDUFA

DMF Review : Complete

Rev. Date : 2014-05-16

Pay. Date : 2013-01-28

DMF Number : 26052

Submission : 2012-05-14

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

09

Sun Pharmaceutical Industries Ltd

USDMF

Formnext Forum

Not Confirmed

09

Sun Pharmaceutical Industries Ltd

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Digital Content

Buprenorphine Base

GDUFA

DMF Review : Complete

Rev. Date : 2019-05-13

Pay. Date : 2019-04-02

DMF Number : 33097

Submission : 2019-03-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Teva Pharmaceutical Industries Ltd

USDMF

Formnext Forum

Not Confirmed

10

Teva Pharmaceutical Industries Ltd

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Digital Content

Buprenorphine

GDUFA

DMF Review : Complete

Rev. Date : 2015-02-25

Pay. Date : 2014-04-29

DMF Number : 28075

Submission : 2014-03-06

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

1
2

Buprenorphine Manufacturers | Traders | Suppliers

Buprenorphine Manufacturers, Traders, Suppliers 1

35

We have 9 companies offering Buprenorphine

Get in contact with the supplier of your choice:

Veranova
Noramco
Arevipharma
Fujifilm Diosynth Biotechnologies
Mallinckrodt Pharmaceuticals
Siegfried AG
Sun Pharmaceutical Industries Limited
Tasmanian Alkaloids Pty Ltd
Teva API

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