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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 Mercaptopurine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mercaptopurine, including repackagers and relabelers. The FDA regulates Mercaptopurine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mercaptopurine 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 Mercaptopurine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mercaptopurine supplier is an individual or a company that provides Mercaptopurine active pharmaceutical ingredient (API) or Mercaptopurine finished formulations upon request. The Mercaptopurine suppliers may include Mercaptopurine API manufacturers, exporters, distributors and traders.
click here to find a list of Mercaptopurine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mercaptopurine CEP of the European Pharmacopoeia monograph is often referred to as a Mercaptopurine Certificate of Suitability (COS). The purpose of a Mercaptopurine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mercaptopurine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mercaptopurine to their clients by showing that a Mercaptopurine CEP has been issued for it. The manufacturer submits a Mercaptopurine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mercaptopurine CEP holder for the record. Additionally, the data presented in the Mercaptopurine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mercaptopurine DMF.
A Mercaptopurine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mercaptopurine 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 Mercaptopurine suppliers with CEP (COS) on PharmaCompass.
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