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

Client Email

Product

Butalbital
Aspirin
Paracetamol
Codeine Phosphate
Caffeine
USDMF

Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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xyz-pharma-m-2024-10-07

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Ribobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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xyz-pharma-m-2024-10-07

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Butalbital

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

8 API Suppliers, 8 USDMF, 10 NDC API, 1 Listed Suppliers, $ API Reference Price

8 API Suppliers
8 USDMF
10 NDC API
1 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

PRICE INFORMATION

API Reference Price, API Imports

API Reference Price
API Imports

FINISHED DOSAGE FORMULATIONS

128 FDF Dossiers, 113 FDA Orange Book, 8 Canada, 7 Listed Dossiers

128 FDF Dossiers
113 FDA Orange Book
8 Canada
7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET;ORAL - 325MG;50MG;40MG, TABLET;ORAL - 325MG;50MG;40MG

TABLET;ORAL - 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - 325MG;50MG;40MG;30MG
CAPSULE;ORAL - 325MG;50MG;40MG;30MG
TABLET;ORAL - 325MG;50MG;40MG
TABLET;ORAL - 325MG;50MG;40MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 7 SPI Pharma, 2 Seqens, 10 DKSH, 2 Jai Radhe Sales, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 30 BASF, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 30 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 30 Roquette, 8 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

80 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 44 Disintegrants & Superdisintegrants, 41 Direct Compression, 30 Thickeners and Stabilizers, 29 Controlled & Modified Release, 28 Granulation, 26 Lubricants & Glidants, 18 Film Formers & Plasticizers, 18 Taste Masking, 16 Co-Processed Excipients, 16 Solubilizers, 13 Chewable & Orodispersible Aids, 13 Parenteral, 13 Topical, 9 Empty Capsules, 5 Coloring Agents, 5 Emulsifying Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Rheology Modifiers, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

80 Fillers, Diluents & Binders
51 Coating Systems & Additives
44 Disintegrants & Superdisintegrants
41 Direct Compression
30 Thickeners and Stabilizers
29 Controlled & Modified Release
28 Granulation
26 Lubricants & Glidants
18 Film Formers & Plasticizers
18 Taste Masking
16 Co-Processed Excipients
16 Solubilizers
13 Chewable & Orodispersible Aids
13 Parenteral
13 Topical
9 Empty Capsules
5 Coloring Agents
5 Emulsifying Agents
4 Vegetarian Capsules
4 API Stability Enhancers
3 Rheology Modifiers
1 Soft Gelatin
1 Surfactant & Foaming Agents

DIGITAL CONTENT

27 NEWS #PharmaBuzz

27 NEWS #PharmaBuzz

MARKET PLACE

1 APIs

1 APIs

REF. STANDARDS & IMPURITIES

1 USP, 4 Others

1 USP
4 Others

$ API Ref.Price (USD/KG) : 1,017 Xls

Filters

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8 All

01 1Chemische Fabrik Berg

02 1Cambrex Corporation

03 1Chattem Chemicals, Inc

04 1Mallinckrodt Pharmaceuticals

05 1Pisgah Labs

06 2Sandoz B2B

07 1Siegfried AG

filter Subject Reset all filters

8 All

01 4BUTALBITAL

02 2BUTALBITAL USP

03 1BUTALBITAL USP, CODE 5678

04 1BUTALBITAL, USP

filter Country Reset all filters

8 All

01 1Germany

02 1Ireland

03 3Switzerland

04 3U.S.A

filter Status Reset all filters

8 All

01 3Active

02 5Inactive

filter GDUFA DMF Review Reset all filters

8 All

01 3Complete

02 5Blank

API Suppliers
USDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Chemische Fabrik Berg Gmbh

AAPS 2024

Not Confirmed

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-06

Pay. Date : 2013-02-20

DMF Number : 4395

Submission : 1981-11-25

Status : Active

Type : II

Moehs Chemische Fabrik Berg

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Cambrex Charles City Inc

USDMF

AAPS 2024

Not Confirmed

02

Cambrex Charles City Inc

AAPS 2024

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17054

Submission : 2003-12-12

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Chattem Chemicals Inc

USDMF

AAPS 2024

Not Confirmed

03

Chattem Chemicals Inc

AAPS 2024

Not Confirmed

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Digital Content

Butalbital, Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-04-18

Pay. Date : 2014-04-11

DMF Number : 15986

Submission : 2002-05-24

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

04

Mallinckrodt Inc

USDMF

AAPS 2024

Not Confirmed

04

Mallinckrodt Inc

AAPS 2024

Not Confirmed

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Digital Content

Butalbital Usp, Code 5678

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18086

Submission : 2005-02-04

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Pisgah Labs Inc

USDMF

AAPS 2024

Not Confirmed

05

Pisgah Labs Inc

AAPS 2024

Not Confirmed

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Digital Content

Butalbital Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16209

Submission : 2002-10-24

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Sandoz Ltd Pharmaceutical Div Chemic...

USDMF

AAPS 2024

Not Confirmed

06

Sandoz Ltd Pharmaceutical Div Chemic...

AAPS 2024

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5645

Submission : 1984-12-07

Status : Inactive

Type : II

Product Web Link

Digital Content

07

Sandoz Pharmaceuticals Corp Div Sand...

USDMF

AAPS 2024

Not Confirmed

07

Sandoz Pharmaceuticals Corp Div Sand...

AAPS 2024

Not Confirmed

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Post an Enquiry

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5610

Submission : 1984-12-03

Status : Inactive

Type : II

Product Web Link

Digital Content

08

Siegfried Usa Llc

USDMF

AAPS 2024

Not Confirmed

08

Siegfried Usa Llc

AAPS 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Butalbital Usp

GDUFA

DMF Review : Complete

Rev. Date : 2012-11-11

Pay. Date : 2012-12-03

DMF Number : 1166

Submission : 1968-04-09

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Butalbital Manufacturers | Traders | Suppliers

Butalbital Manufacturers, Traders, Suppliers 1

82

We have 7 companies offering Butalbital

Get in contact with the supplier of your choice:

Chemische Fabrik Berg
Cambrex Corporation
Chattem Chemicals, Inc
Mallinckrodt Pharmaceuticals
Pisgah Labs
Sandoz B2B
Siegfried AG

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