01 1IPCA Laboratories Limited Mumbai IN
02 1Interquim S.A. DE C.V. Estado De Mexico MX
01 2Pyrimethamine
01 1India
02 1Mexico
01 2Valid
Certificate Number : R0-CEP 2022-045 - Rev 00
Status : Valid
Issue Date : 2023-08-23
Type : Chemical
Substance Number : 288
Certificate Number : R1-CEP 2009-183 - Rev 02
Status : Valid
Issue Date : 2019-03-28
Type : Chemical
Substance Number : 288
A Daraprim manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daraprim, including repackagers and relabelers. The FDA regulates Daraprim manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daraprim 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 Daraprim manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Daraprim supplier is an individual or a company that provides Daraprim active pharmaceutical ingredient (API) or Daraprim finished formulations upon request. The Daraprim suppliers may include Daraprim API manufacturers, exporters, distributors and traders.
click here to find a list of Daraprim suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Daraprim CEP of the European Pharmacopoeia monograph is often referred to as a Daraprim Certificate of Suitability (COS). The purpose of a Daraprim CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Daraprim EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Daraprim to their clients by showing that a Daraprim CEP has been issued for it. The manufacturer submits a Daraprim CEP (COS) as part of the market authorization procedure, and it takes on the role of a Daraprim CEP holder for the record. Additionally, the data presented in the Daraprim CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Daraprim DMF.
A Daraprim CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Daraprim 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 Daraprim suppliers with CEP (COS) on PharmaCompass.
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