01 1ARCHIMICA S.P.A Lodi IT
02 1HETERO LABS LIMITED Hyderabad IN
03 1MACLEODS PHARMACEUTICALS LIMITED Mumbai IN
04 1SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN
05 1SUMITOMO CHEMICAL COMPANY LIMITED Osaka JP
01 5Hydralazine hydrochloride
01 3India
02 1Italy
03 1Japan
01 1Expired
02 4Valid
Certificate Number : R0-CEP 2015-161 - Rev 01
Status : Expired
Issue Date : 2020-10-29
Type : Chemical
Substance Number : 829
Certificate Number : CEP 2018-287 - Rev 02
Status : Valid
Issue Date : 2024-03-20
Type : Chemical
Substance Number : 829
Certificate Number : R1-CEP 2016-180 - Rev 00
Status : Valid
Issue Date : 2023-03-27
Type : Chemical
Substance Number : 829
Certificate Number : CEP 2013-191 - Rev 03
Status : Valid
Issue Date : 2024-06-26
Type : Chemical
Substance Number : 829
Certificate Number : CEP 2018-170 - Rev 03
Status : Valid
Issue Date : 2024-10-22
Type : Chemical
Substance Number : 829
A Hyperex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyperex, including repackagers and relabelers. The FDA regulates Hyperex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyperex 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 Hyperex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hyperex supplier is an individual or a company that provides Hyperex active pharmaceutical ingredient (API) or Hyperex finished formulations upon request. The Hyperex suppliers may include Hyperex API manufacturers, exporters, distributors and traders.
click here to find a list of Hyperex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hyperex CEP of the European Pharmacopoeia monograph is often referred to as a Hyperex Certificate of Suitability (COS). The purpose of a Hyperex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hyperex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hyperex to their clients by showing that a Hyperex CEP has been issued for it. The manufacturer submits a Hyperex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hyperex CEP holder for the record. Additionally, the data presented in the Hyperex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hyperex DMF.
A Hyperex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hyperex 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 Hyperex suppliers with CEP (COS) on PharmaCompass.
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