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

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01 Chemische Fabrik Berg (1)

02 Aarti Drugs (1)

03 COSMA S.p.A (1)

04 Calyx Chemicals & Pharmaceuticals Limited (1)

05 Chemi SpA (1)

06 DMFs Not Supported (3)

07 Fleming Laboratories (1)

08 Glochem Industries (1)

09 Ipca Laboratories (1)

10 Siegfried AG (1)

11 Srikem Laboratories Pvt. Ltd (1)

12 Symed Labs (1)

13 Teikoku Seiyaku Co., Ltd. (1)

14 UCB Pharma S.A (2)

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01 HYDROXYZINE HCL (4)

02 HYDROXYZINE HCL N.F. XIV (1)

03 HYDROXYZINE HCL.USP. XX 093082 (1)

04 HYDROXYZINE HYDROCHIORIDE (1)

05 HYDROXYZINE HYDROCHLORIDE (6)

06 HYDROXYZINE HYDROCHLORIDE COMPACTED (1)

07 HYDROXYZINE HYDROCHLORIDE USP (3)

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01 Belgium (2)

02 Germany (1)

03 India (7)

04 Italy (2)

05 Japan (1)

06 Switzerland (1)

07 Blank (3)

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01 Active (8)

02 Inactive (9)

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01 Complete (5)

02 Blank (12)

URL Supplier Web Content
35249
Active
2023-12-05
Complete
2024-03-12
2023-12-01
II
Moehs Chemische Fabrik Berg

Iran Expo

Not Confirmed

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URL Supplier Web Content
24002
Active
2010-07-22
N/A
II
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4435
Active
1982-01-29
Complete
2014-05-15
2014-01-28
II
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INDUSTRIA CHIMICA PROFARMACO SPA

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URL Supplier Web Content
2807
Inactive
1976-11-22
N/A
II
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URL Supplier Web Content
38273
Active
2023-08-10
N/A
II
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URL Supplier Web Content
37118
Active
2022-11-17
N/A
II
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23283
Active
2010-04-09
Complete
2013-12-17
2013-08-08
II
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URL Supplier Web Content
28376
Active
2014-06-06
Complete
2015-03-03
2014-07-11
II
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19596
Active
2006-07-12
Complete
2016-11-18
2016-10-24
II
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URL Supplier Web Content
3037
Inactive
1977-10-13
N/A
II
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Looking for 1244-76-4 / Hydroxyzine Hydrochloride API manufacturers, exporters & distributors?

Hydroxyzine Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Hydroxyzine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Hydroxyzine Hydrochloride manufacturer or Hydroxyzine Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydroxyzine Hydrochloride manufacturer or Hydroxyzine Hydrochloride supplier.

PharmaCompass also assists you with knowing the Hydroxyzine Hydrochloride API Price utilized in the formulation of products. Hydroxyzine Hydrochloride API Price is not always fixed or binding as the Hydroxyzine Hydrochloride Price is obtained through a variety of data sources. The Hydroxyzine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Hydroxyzine Hydrochloride

Synonyms

Hydroxyzine hcl, 1244-76-4, Hydroxyzine monohydrochloride, Ca67jf5q4w, Mls000028602, Smr000058737

Cas Number

1244-76-4

Unique Ingredient Identifier (UNII)

CA67JF5Q4W

About Hydroxyzine Hydrochloride

A histamine H1 receptor antagonist that is effective in the treatment of chronic urticaria, dermatitis, and histamine-mediated pruritus. Unlike its major metabolite CETIRIZINE, it does cause drowsiness. It is also effective as an antiemetic, for relief of anxiety and tension, and as a sedative.

Hydroxyzine Manufacturers

A Hydroxyzine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxyzine, including repackagers and relabelers. The FDA regulates Hydroxyzine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxyzine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Hydroxyzine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Hydroxyzine Suppliers

A Hydroxyzine supplier is an individual or a company that provides Hydroxyzine active pharmaceutical ingredient (API) or Hydroxyzine finished formulations upon request. The Hydroxyzine suppliers may include Hydroxyzine API manufacturers, exporters, distributors and traders.

click here to find a list of Hydroxyzine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Hydroxyzine USDMF

A Hydroxyzine DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydroxyzine active pharmaceutical ingredient (API) in detail. Different forms of Hydroxyzine DMFs exist exist since differing nations have different regulations, such as Hydroxyzine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Hydroxyzine DMF submitted to regulatory agencies in the US is known as a USDMF. Hydroxyzine USDMF includes data on Hydroxyzine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydroxyzine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Hydroxyzine suppliers with USDMF on PharmaCompass.

Hydroxyzine Manufacturers | Traders | Suppliers

Hydroxyzine Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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