Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
01 1TARCHOMINSKIE ZAKLADY FARMACEUTYCZNE POLFA S.A. Warsaw PL
02 1JIANGSU HENGRUI MEDICINE CO., LTD. Lianyungang CN
01 2Ifosfamide
01 1China
02 1Poland
01 1Valid
02 1Withdrawn by Holder
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Certificate Number : CEP 2006-238 - Rev 02
Status : Valid
Issue Date : 2024-08-02
Type : Chemical
Substance Number : 1529
Certificate Number : R1-CEP 2013-026 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2019-09-04
Type : Chemical
Substance Number : 1529
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A Holoxan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Holoxan, including repackagers and relabelers. The FDA regulates Holoxan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Holoxan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Holoxan supplier is an individual or a company that provides Holoxan active pharmaceutical ingredient (API) or Holoxan finished formulations upon request. The Holoxan suppliers may include Holoxan API manufacturers, exporters, distributors and traders.
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A Holoxan CEP of the European Pharmacopoeia monograph is often referred to as a Holoxan Certificate of Suitability (COS). The purpose of a Holoxan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Holoxan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Holoxan to their clients by showing that a Holoxan CEP has been issued for it. The manufacturer submits a Holoxan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Holoxan CEP holder for the record. Additionally, the data presented in the Holoxan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Holoxan DMF.
A Holoxan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Holoxan CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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