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

Client Email

Product

Hydroxyzine Hydrochloride
2192-20-3
CAS 303-26-4
USDMF

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Hydroxyzine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 18 USDMF, 4 CEP/COS, 6 EU WC, 4 KDMF, 23 NDC API, 17 Listed Suppliers, $ API Reference Price

30 API Suppliers
18 USDMF
4 CEP/COS
6 EU WC
4 KDMF
23 NDC API
17 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

API Reference Price, API Exports, API Imports

API Reference Price
API Exports
API Imports

FINISHED DOSAGE FORMULATIONS

216 FDF Dossiers, 145 FDA Orange Book, 37 Europe, 11 Canada, 6 South Africa, 17 Listed Dossiers

216 FDF Dossiers
145 FDA Orange Book
37 Europe
11 Canada
6 South Africa
17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 10MG/5ML, INJECTABLE;INJECTION - 25MG/ML, INJECTABLE;INJECTION - 50MG/ML, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG

INJECTABLE;INJECTION - 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SYRUP;ORAL - 10MG/5ML
INJECTABLE;INJECTION - 25MG/ML
INJECTABLE;INJECTION - 50MG/ML
TABLET;ORAL - 25MG
TABLET;ORAL - 50MG

DIGITAL CONTENT

8 NEWS #PharmaBuzz

8 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

32 Finished Drug Prices

32 Finished Drug Prices

MARKET PLACE

9 APIs, 3 FDF Dossiers

9 APIs
3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 2 USP, 1 Others

1 EDQM
2 USP
1 Others

$ API Ref.Price (USD/KG) : 153 Xls

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18 All

01 1Chemische Fabrik Berg

02 1Aarti Drugs

03 1COSMA S.p.A

04 1Calyx Chemicals & Pharmaceuticals Limited

05 1Chemi SpA

06 3DMFs Not Supported

07 1Emcure Pharmaceuticals

08 1Fleming Laboratories

09 1Glochem Industries

10 1Ipca Laboratories

11 1Siegfried AG

12 1Srikem Laboratories Pvt. Ltd

13 1Symed Labs

14 1Teikoku Seiyaku Co., Ltd.

15 2UCB Pharma S.A

filter Subject Reset all filters

18 All

01 4HYDROXYZINE HCL

02 1HYDROXYZINE HCL N.F. XIV

03 1HYDROXYZINE HCL.USP. XX 093082

04 1HYDROXYZINE HYDROCHIORIDE

05 6HYDROXYZINE HYDROCHLORIDE

06 1HYDROXYZINE HYDROCHLORIDE COMPACTED

07 4HYDROXYZINE HYDROCHLORIDE USP

filter Country Reset all filters

18 All

01 2Belgium

02 1Germany

03 8India

04 2Italy

05 1Japan

06 1Switzerland

07 3Blank

filter Status Reset all filters

18 All

01 9Active

02 9Inactive

filter GDUFA DMF Review Reset all filters

18 All

01 5Complete

02 13Blank

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

List of Suppliers

Product Main Page

01

Chemische Fabrik Berg Gmbh

Luxepack

Not Confirmed

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Digital Content

Hydroxyzine Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2024-03-12

Pay. Date : 2023-12-01

DMF Number : 35249

Submission : 2023-12-05

Status : Active

Type : II

Moehs Chemische Fabrik Berg

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Calyx Chemicals And Pharmaceuticals ...

USDMF

Luxepack

Not Confirmed

02

Calyx Chemicals And Pharmaceuticals ...

Luxepack

Not Confirmed

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Digital Content

Hydroxyzine Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 24002

Submission : 2010-07-22

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

03

Cosma Spa

USDMF

Luxepack

Not Confirmed

03

Cosma Spa

Luxepack

Not Confirmed

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Digital Content

Hydroxyzine Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2014-05-15

Pay. Date : 2014-01-28

DMF Number : 4435

Submission : 1982-01-29

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Industria Chimica Profarmaco Spa

Country

USDMF

Luxepack

Not Confirmed

04

Industria Chimica Profarmaco Spa

Country

Luxepack

Not Confirmed

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Country

Virtual Booth

Digital Content

Hydroxyzine Hcl

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2807

Submission : 1976-11-22

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

05

Emcure Pharmaceuticals Ltd

USDMF

Luxepack

Not Confirmed

05

Emcure Pharmaceuticals Ltd

Luxepack

Not Confirmed

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Digital Content

Hydroxyzine Hydrochloride Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39539

Submission : 2024-03-04

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

06

Fleming Laboratories Ltd

USDMF

Luxepack

Not Confirmed

06

Fleming Laboratories Ltd

Luxepack

Not Confirmed

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Digital Content

Hydroxyzine Hydrochloride Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38273

Submission : 2023-08-10

Status : Active

Type : II

Product Web Link

Digital Content

07

Glochem Industries Private Ltd

USDMF

Luxepack

Not Confirmed

07

Glochem Industries Private Ltd

Luxepack

Not Confirmed

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Digital Content

Hydroxyzine Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37118

Submission : 2022-11-17

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

08

Ipca Laboratories Ltd

USDMF

Luxepack

Not Confirmed

08

Ipca Laboratories Ltd

Luxepack

Not Confirmed

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Digital Content

Hydroxyzine Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-12-17

Pay. Date : 2013-08-08

DMF Number : 23283

Submission : 2010-04-09

Status : Active

Type : II

Product Web Link

Digital Content

09

Srikem Laboratories Pvt Ltd

USDMF

Luxepack

Not Confirmed

09

Srikem Laboratories Pvt Ltd

Luxepack

Not Confirmed

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Digital Content

Hydroxyzine Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2015-03-03

Pay. Date : 2014-07-11

DMF Number : 28376

Submission : 2014-06-06

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

10

Symed Labs Ltd

USDMF

Luxepack

Not Confirmed

10

Symed Labs Ltd

Luxepack

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

Hydroxyzine Hydrochloride

GDUFA

DMF Review : Complete

Rev. Date : 2016-11-18

Pay. Date : 2016-10-24

DMF Number : 19596

Submission : 2006-07-12

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

1
2

Hydroxyzine Hydrochloride Manufacturers | Traders | Suppliers

Hydroxyzine Hydrochloride Manufacturers, Traders, Suppliers 1

46

We have 14 companies offering Hydroxyzine Hydrochloride

Get in contact with the supplier of your choice:

Chemische Fabrik Berg
Aarti Drugs
Calyx Chemicals & Pharmaceuticals Limited
Chemi SpA
COSMA S.p.A
Emcure Pharmaceuticals
Fleming Laboratories
Glochem Industries
Ipca Laboratories
Siegfried AG
Srikem Laboratories Pvt. Ltd
Symed Labs
Teikoku Seiyaku Co., Ltd.
UCB Pharma S.A

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