01 1FLEMING LABORATORIES LIMITED Nawabpet Village IN
02 1GLOCHEM INDUSTRIES PRIVATE LIMITED Hyderabad IN
03 1IPCA LABORATORIES LIMITED Mumbai IN
04 1KREATIVE ORGANICS PRIVATE LIMITED Hyderabad IN
05 1SYMED LABS LIMITED Hyderabad IN
01 5Hydroxyzine hydrochloride
01 5India
01 5Valid
Certificate Number : CEP 2021-436 - Rev 00
Status : Valid
Issue Date : 2024-10-08
Type : Chemical
Substance Number : 916
Certificate Number : CEP 2022-318 - Rev 00
Status : Valid
Issue Date : 2024-06-05
Type : Chemical
Substance Number : 916
Certificate Number : CEP 2010-076 - Rev 03
Status : Valid
Issue Date : 2024-09-11
Type : Chemical
Substance Number : 916
Certificate Number : CEP 2016-056 - Rev 01
Status : Valid
Issue Date : 2024-10-16
Type : Chemical
Substance Number : 916
Certificate Number : R1-CEP 2015-186 - Rev 00
Status : Valid
Issue Date : 2021-07-12
Type : Chemical
Substance Number : 916
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 CEP of the European Pharmacopoeia monograph is often referred to as a Hydroxyzine Certificate of Suitability (COS). The purpose of a Hydroxyzine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydroxyzine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydroxyzine to their clients by showing that a Hydroxyzine CEP has been issued for it. The manufacturer submits a Hydroxyzine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydroxyzine CEP holder for the record. Additionally, the data presented in the Hydroxyzine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydroxyzine DMF.
A Hydroxyzine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hydroxyzine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Hydroxyzine suppliers with CEP (COS) on PharmaCompass.
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