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
15 2UCB Pharma S.A
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-12
Pay. Date : 2023-12-01
DMF Number : 35249
Submission : 2023-12-05
Status :
Type : II
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.
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.
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.
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