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List of Drug Master Files (DMF) of 08H Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

08H
Palmitoylethanolamide
CAS 59-92-7
3-Amino-3-3-Chlorophenyl-Propanoic Acid
CAS 15574-49-9
Edotreotide
CAS 2234-16-4
USDMF

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08H

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 14 USDMF, 7 CEP/COS, 3 JDMF, 6 EU WC, 7 KDMF, 6 NDC API, 14 Listed Suppliers, $ API Reference Price

26 API Suppliers
14 USDMF
7 CEP/COS
3 JDMF
6 EU WC
7 KDMF
6 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

454 FDF Dossiers, 143 FDA Orange Book, 188 Europe, 20 Canada, 5 Australia, 42 South Africa, 56 Listed Dossiers

454 FDF Dossiers
143 FDA Orange Book
188 Europe
20 Canada
5 Australia
42 South Africa
56 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.25MG, TABLET;ORAL - 0.5MG, TABLET;ORAL - 1MG, TABLET;ORAL - 2MG, TABLET, EXTENDED RELEASE;ORAL - 0.5MG, TABLET, EXTENDED RELEASE;ORAL - 1MG, TABLET, EXTENDED RELEASE;ORAL - 2MG, TABLET, EXTENDED RELEASE;ORAL - 3MG

TABLET;ORAL - 0.25MG
TABLET;ORAL - 0.5MG
TABLET;ORAL - 1MG
TABLET;ORAL - 2MG
TABLET, EXTENDED RELEASE;ORAL - 0.5MG
TABLET, EXTENDED RELEASE;ORAL - 1MG
TABLET, EXTENDED RELEASE;ORAL - 2MG
TABLET, EXTENDED RELEASE;ORAL - 3MG

RELATED EXCIPIENT COMPANIES

2 Evonik, 5 Rochem International Inc, 17 SPI Pharma, 1 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 15 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 4 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 24 BASF, 1 Bioplus Life Sciences, 14 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 12 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 29 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

87 Fillers, Diluents & Binders, 65 Coating Systems & Additives, 46 Direct Compression, 41 Disintegrants & Superdisintegrants, 37 Controlled & Modified Release, 28 Granulation, 28 Taste Masking, 27 Solubilizers, 23 Thickeners and Stabilizers, 20 Co-Processed Excipients, 20 Chewable & Orodispersible Aids, 19 Film Formers & Plasticizers, 17 Lubricants & Glidants, 16 Parenteral, 8 Emulsifying Agents, 8 Topical, 7 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Rheology Modifiers, 3 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Soft Gelatin

87 Fillers, Diluents & Binders
65 Coating Systems & Additives
46 Direct Compression
41 Disintegrants & Superdisintegrants
37 Controlled & Modified Release
28 Granulation
28 Taste Masking
27 Solubilizers
23 Thickeners and Stabilizers
20 Co-Processed Excipients
20 Chewable & Orodispersible Aids
19 Film Formers & Plasticizers
17 Lubricants & Glidants
16 Parenteral
8 Emulsifying Agents
8 Topical
7 API Stability Enhancers
5 Empty Capsules
4 Vegetarian Capsules
4 Rheology Modifiers
3 Surfactant & Foaming Agents
2 Coloring Agents
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 38 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
38 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 188 Finished Drug Prices, 9 Annual Reports

5 US Medicaid Prescriptions
188 Finished Drug Prices
9 Annual Reports

MARKET PLACE

15 APIs, 18 FDF Dossiers

15 APIs
18 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 8 Others

3 EDQM
2 USP
8 Others

$ API Ref.Price (USD/KG) : 793 Xls

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14 All

01 1Malladi Drugs & Pharmaceuticals Limited

02 1Fermion Oy

03 1ALP Pharm

04 1Apotex Pharmachem

05 1Cambrex Corporation

06 1Centaur Pharmaceuticals

07 1Cipla

08 1Fujifilm Diosynth Biotechnologies

09 1Lake Chemicals

10 1Par Pharmaceutical

11 1Qilu Tianhe Pharmaceutical Co., Ltd.

12 1R L Fine Chem

13 1Viatris

14 1Zambon Switzerland

filter Subject Reset all filters

14 All

01 7ALPRAZOLAM

02 1ALPRAZOLAM DRUG SUBSTANCE

03 4ALPRAZOLAM USP

04 1ALPRAZOLAM USP (DRUG SUBSTANCE, NON-STERILE)

05 1ALPRAZOLAM USP (NON STERILE API)

filter Country Reset all filters

14 All

01 1Canada

02 2China

03 1Finland

04 5India

05 1Switzerland

06 3U.S.A

07 1United Kingdom

filter Status Reset all filters

14 All

01 7Active

02 7Inactive

filter GDUFA DMF Review Reset all filters

14 All

01 4Complete

02 10Blank

Malladi Alprazolam

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

List of Suppliers

Product Main Page

01

Malladi Drugs And Pharmaceuticals Lt...

CPhI Worldwide, Milan

Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2023-07-17

Pay. Date : 2023-07-13

DMF Number : 20448

Submission : 2007-04-10

Status : Active

Type : II

Product Web Link

Digital Content

02

Fermion Oy

CPhI Worldwide, Milan

With Fermion, start the journey of your innovative API.

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2020-12-30

Pay. Date : 2020-12-23

DMF Number : 9043

Submission : 1991-04-04

Status : Active

Type : II

Product Web Link

Digital Content

03

Cambrex Profarmaco Milano Srl

USDMF

Formnext Forum

Not Confirmed

03

Cambrex Profarmaco Milano Srl

Formnext Forum

Not Confirmed

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-08-13

Pay. Date : 2013-08-02

DMF Number : 7094

Submission : 1987-08-04

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Centaur Pharmaceuticals Pvt Ltd

USDMF

Formnext Forum

Not Confirmed

04

Centaur Pharmaceuticals Pvt Ltd

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Not Confirmed

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Digital Content

Alprazolam Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-05-01

Pay. Date : 2014-04-25

DMF Number : 20827

Submission : 2007-08-30

Status : Active

Type : II

Product Web Link

Digital Content

05

Cipla Ltd

USDMF

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Not Confirmed

05

Cipla Ltd

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Not Confirmed

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Digital Content

Alprazolam Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 8060

Submission : 1989-05-06

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Diosynth Bv

USDMF

Formnext Forum

Not Confirmed

06

Diosynth Bv

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Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9128

Submission : 1991-05-20

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Endo Operations Ltd

USDMF

Formnext Forum

Not Confirmed

07

Endo Operations Ltd

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Digital Content

Alprazolam Drug Substance

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18075

Submission : 2005-02-06

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Rl Fine Chem Pvt Ltd

USDMF

Formnext Forum

Not Confirmed

08

Rl Fine Chem Pvt Ltd

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Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 33417

Submission : 2019-01-31

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Tianish Laboratories Private Ltd

USDMF

Formnext Forum

Not Confirmed

09

Tianish Laboratories Private Ltd

Formnext Forum

Not Confirmed

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Digital Content

Alprazolam Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18214

Submission : 2005-03-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zambon Spa

USDMF

Formnext Forum

Not Confirmed

10

Zambon Spa

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Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 8860

Submission : 1990-11-26

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

08H Manufacturers | Traders | Suppliers

08H Manufacturers, Traders, Suppliers 1

73

We have 14 companies offering 08H

Get in contact with the supplier of your choice:

Fermion Oy
Malladi Drugs & Pharmaceuticals Limited
ALP Pharm
Apotex Pharmachem
Cambrex Corporation
Centaur Pharmaceuticals
Cipla
Fujifilm Diosynth Biotechnologies
Lake Chemicals
Par Pharmaceutical
Qilu Tianhe Pharmaceutical Co., Ltd.
R L Fine Chem
Viatris
Zambon Switzerland

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