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01 1FERMION OY Espoo FI
02 1AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN
01 2Mercaptopurine monohydrate
01 1Finland
02 1India
01 2Valid
Certificate Number : R1-CEP 2009-074 - Rev 03
Status : Valid
Issue Date : 2021-01-11
Type : Chemical
Substance Number : 96
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Certificate Number : R0-CEP 2021-275 - Rev 00
Status : Valid
Issue Date : 2023-08-09
Type : Chemical
Substance Number : 96
A Purinethol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Purinethol, including repackagers and relabelers. The FDA regulates Purinethol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Purinethol 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 Purinethol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Purinethol supplier is an individual or a company that provides Purinethol active pharmaceutical ingredient (API) or Purinethol finished formulations upon request. The Purinethol suppliers may include Purinethol API manufacturers, exporters, distributors and traders.
click here to find a list of Purinethol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Purinethol CEP of the European Pharmacopoeia monograph is often referred to as a Purinethol Certificate of Suitability (COS). The purpose of a Purinethol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Purinethol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Purinethol to their clients by showing that a Purinethol CEP has been issued for it. The manufacturer submits a Purinethol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Purinethol CEP holder for the record. Additionally, the data presented in the Purinethol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Purinethol DMF.
A Purinethol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Purinethol 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 Purinethol suppliers with CEP (COS) on PharmaCompass.
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