01 2ARCHIMICA S.P.A Lodi IT
02 1ASAHI KASEI FINECHEM CO., LTD. Osaka JP
03 1MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN
04 1Zhejiang Hisun Pharmaceutical Co., Ltd. Taizhou City CN
01 4Cytarabine
02 1Cytarabine, Process 2
01 1China
02 1India
03 2Italy
04 1Japan
01 4Valid
02 1Withdrawn by Holder
Certificate Number : R1-CEP 2000-048 - Rev 04
Status : Valid
Issue Date : 2020-10-16
Type : Chemical
Substance Number : 760
Certificate Number : CEP 2023-289 - Rev 00
Status : Valid
Issue Date : 2024-02-06
Type : Chemical
Substance Number : 760
Certificate Number : CEP 2017-218 - Rev 03
Status : Valid
Issue Date : 2024-09-20
Type : Chemical
Substance Number : 760
Certificate Number : CEP 2012-251 - Rev 02
Status : Valid
Issue Date : 2024-04-30
Type : Chemical
Substance Number : 760
Certificate Number : R1-CEP 2001-390 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2016-08-02
Type : Chemical
Substance Number : 760
A Alexan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alexan, including repackagers and relabelers. The FDA regulates Alexan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alexan 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 Alexan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alexan supplier is an individual or a company that provides Alexan active pharmaceutical ingredient (API) or Alexan finished formulations upon request. The Alexan suppliers may include Alexan API manufacturers, exporters, distributors and traders.
click here to find a list of Alexan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alexan CEP of the European Pharmacopoeia monograph is often referred to as a Alexan Certificate of Suitability (COS). The purpose of a Alexan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alexan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alexan to their clients by showing that a Alexan CEP has been issued for it. The manufacturer submits a Alexan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alexan CEP holder for the record. Additionally, the data presented in the Alexan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alexan DMF.
A Alexan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alexan 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 Alexan suppliers with CEP (COS) on PharmaCompass.
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