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

Client Email

Product

Hydromorphone
CAS 320-51-4
CAS 57-27-2
Dimorphone
USDMF

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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Hydromorphone

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 12 USDMF, 7 CEP/COS, 1 JDMF, 2 KDMF, 23 NDC API, 10 Listed Suppliers, $ API Reference Price

21 API Suppliers
12 USDMF
7 CEP/COS
1 JDMF
2 KDMF
23 NDC API
10 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

API Reference Price

API Reference Price

FINISHED DOSAGE FORMULATIONS

218 FDF Dossiers, 75 FDA Orange Book, 36 Europe, 42 Canada, 40 Australia, 5 South Africa, 20 Listed Dossiers

218 FDF Dossiers
75 FDA Orange Book
36 Europe
42 Canada
40 Australia
5 South Africa
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 0.2MG/ML, INJECTABLE;INJECTION - 0.5MG/0.5ML, INJECTABLE;INJECTION - 10MG/ML, INJECTABLE;INJECTION - 1MG/ML, INJECTABLE;INJECTION - 2MG/ML, INJECTABLE;INJECTION - 4MG/ML, SOLUTION;ORAL - 5MG/5ML, TABLET;ORAL - 2MG, TABLET;ORAL - 4MG, TABLET;ORAL - 8MG, TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 0.2MG/ML
INJECTABLE;INJECTION - 0.5MG/0.5ML
INJECTABLE;INJECTION - 10MG/ML
INJECTABLE;INJECTION - 1MG/ML
INJECTABLE;INJECTION - 2MG/ML
INJECTABLE;INJECTION - 4MG/ML
SOLUTION;ORAL - 5MG/5ML
TABLET;ORAL - 2MG
TABLET;ORAL - 4MG
TABLET;ORAL - 8MG
TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Evonik, 2 Rochem International Inc, 14 SPI Pharma, 2 Seqens, 4 DKSH, 1 Jai Radhe Sales, 6 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 24 Roquette, 12 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

90 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 41 Direct Compression, 36 Controlled & Modified Release, 29 Film Formers & Plasticizers, 28 Solubilizers, 28 Parenteral, 26 Thickeners and Stabilizers, 24 Granulation, 20 Co-Processed Excipients, 19 Lubricants & Glidants, 18 Disintegrants & Superdisintegrants, 18 Taste Masking, 18 Topical, 13 Chewable & Orodispersible Aids, 8 API Stability Enhancers, 8 Emulsifying Agents, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Rheology Modifiers, 1 Soft Gelatin

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

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 57 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
57 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 46 Finished Drug Prices

2 US Medicaid Prescriptions
46 Finished Drug Prices

MARKET PLACE

1 APIs, 2 FDF Dossiers

1 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 2 US Exclusivities, 12 Health Canada Patents

14 US Patents
2 US Exclusivities
12 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 USP, 5 Others

2 EDQM
3 USP
5 Others

$ API Ref.Price (USD/KG) : 7,574 Xls

Filters

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12 All

01 1Veranova

02 1Noramco

03 1Chattem Chemicals, Inc

04 3Cody Laboratories, Inc.

05 1Fujifilm Diosynth Biotechnologies

06 3Mallinckrodt Pharmaceuticals

07 1Siegfried AG

08 1Takeda Pharmaceutical

filter Subject Reset all filters

12 All

01 1HYDROMORPHONE BASE

02 1HYDROMORPHONE BASE INTERMEDIATE

03 1HYDROMORPHONE HCI, USP

04 3HYDROMORPHONE HYDROCHLORIDE

05 1HYDROMORPHONE HYDROCHLORIDE DRUG SUBSTANCE

06 2HYDROMORPHONE HYDROCHLORIDE USP

07 1HYDROMORPHONE HYDROCHLORIDE USP (NP)

08 1HYDROMORPHONE HYDROCHLORIDE, USP

09 1HYDROMORPHONE HYDROCHOLORIDE USP

filter Country Reset all filters

12 All

01 3Ireland

02 1Japan

03 1Switzerland

04 6U.S.A

05 1United Kingdom

filter Status Reset all filters

12 All

01 5Active

02 7Inactive

filter GDUFA DMF Review Reset all filters

12 All

01 5Complete

02 7Blank

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

List of Suppliers

Product Main Page

01

Veranova Lp

CPhI Worldwide, Milan

Veranova: A CDMO that manages complexity with confidence.

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Digital Content

Hydromorphone Hci, Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-06

Pay. Date : 2014-05-28

DMF Number : 19846

Submission : 2006-10-06

Status : Active

Type : II

Product Web Link

Digital Content

02

Noramco Llc

CPhI Worldwide, Milan

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

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Digital Content

Hydromorphone Hydrochloride Drug Substance

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-06

Pay. Date : 2012-11-23

DMF Number : 19561

Submission : 2006-06-29

Status : Active

Type : II

Product Web Link

Digital Content

03

Chattem Chemicals Inc

USDMF

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Not Confirmed

03

Chattem Chemicals Inc

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Not Confirmed

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Digital Content

Hydromorphone Hydrochloride, Usp

GDUFA

DMF Review : Complete

Rev. Date : 2017-05-23

Pay. Date : 2016-11-25

DMF Number : 30995

Submission : 2016-11-23

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

04

Cody Laboratories Inc

USDMF

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04

Cody Laboratories Inc

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Digital Content

Hydromorphone Hydrocholoride Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17501

Submission : 2004-06-14

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Diosynth Bv

USDMF

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Not Confirmed

05

Diosynth Bv

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Digital Content

Hydromorphone Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7011

Submission : 1987-06-09

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Specgx Llc

USDMF

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06

Specgx Llc

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Digital Content

Hydromorphone Hydrochloride Usp (np)

GDUFA

DMF Review : Complete

Rev. Date : 2013-06-13

Pay. Date : 2012-11-27

DMF Number : 25766

Submission : 2012-07-25

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Mallinckrodt Inc The Pharmaceuticals...

USDMF

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07

Mallinckrodt Inc The Pharmaceuticals...

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Digital Content

Hydromorphone Base

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18834

Submission : 2005-09-30

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Specgx Llc

USDMF

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Not Confirmed

08

Specgx Llc

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Digital Content

Hydromorphone Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7237

Submission : 1987-11-20

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Siegfried Usa Llc

USDMF

Formnext Forum

Not Confirmed

09

Siegfried Usa Llc

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Digital Content

Hydromorphone Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-18

Pay. Date : 2013-02-14

DMF Number : 22082

Submission : 2008-10-01

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

10

Takeda Pharmaceutical Co Ltd

USDMF

Formnext Forum

Not Confirmed

10

Takeda Pharmaceutical Co Ltd

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Digital Content

Hydromorphone Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7071

Submission : 1987-07-13

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

1
2

Hydromorphone Manufacturers | Traders | Suppliers

Hydromorphone Manufacturers, Traders, Suppliers 1

73

We have 8 companies offering Hydromorphone

Get in contact with the supplier of your choice:

Veranova
Noramco
Chattem Chemicals, Inc
Cody Laboratories, Inc.
Fujifilm Diosynth Biotechnologies
Mallinckrodt Pharmaceuticals
Siegfried AG
Takeda Pharmaceutical

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