01 1APITORIA PHARMA PRIVATE LIMITED Hyderabad IN
02 1FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT
01 2Pivmecillinam hydrochloride
01 1India
02 1Italy
01 2Valid
Certificate Number : CEP 2007-229 - Rev 05
Status : Valid
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 1359
Certificate Number : CEP 2004-262 - Rev 07
Status : Valid
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 1359
A Pivmecillinam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pivmecillinam, including repackagers and relabelers. The FDA regulates Pivmecillinam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pivmecillinam 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 Pivmecillinam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pivmecillinam supplier is an individual or a company that provides Pivmecillinam active pharmaceutical ingredient (API) or Pivmecillinam finished formulations upon request. The Pivmecillinam suppliers may include Pivmecillinam API manufacturers, exporters, distributors and traders.
click here to find a list of Pivmecillinam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pivmecillinam CEP of the European Pharmacopoeia monograph is often referred to as a Pivmecillinam Certificate of Suitability (COS). The purpose of a Pivmecillinam CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pivmecillinam EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pivmecillinam to their clients by showing that a Pivmecillinam CEP has been issued for it. The manufacturer submits a Pivmecillinam CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pivmecillinam CEP holder for the record. Additionally, the data presented in the Pivmecillinam CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pivmecillinam DMF.
A Pivmecillinam CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pivmecillinam 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 Pivmecillinam suppliers with CEP (COS) on PharmaCompass.
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