01 1SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN
01 1Sodium phenylbutyrate
01 1India
01 1Valid
Certificate Number : R0-CEP 2020-082 - Rev 00
Status : Valid
Issue Date : 2023-05-09
Type : Chemical
Substance Number : 2183
A Sodium Phenylbutyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Phenylbutyrate, including repackagers and relabelers. The FDA regulates Sodium Phenylbutyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Phenylbutyrate 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 Sodium Phenylbutyrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Phenylbutyrate supplier is an individual or a company that provides Sodium Phenylbutyrate active pharmaceutical ingredient (API) or Sodium Phenylbutyrate finished formulations upon request. The Sodium Phenylbutyrate suppliers may include Sodium Phenylbutyrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Phenylbutyrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Phenylbutyrate CEP of the European Pharmacopoeia monograph is often referred to as a Sodium Phenylbutyrate Certificate of Suitability (COS). The purpose of a Sodium Phenylbutyrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium Phenylbutyrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium Phenylbutyrate to their clients by showing that a Sodium Phenylbutyrate CEP has been issued for it. The manufacturer submits a Sodium Phenylbutyrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium Phenylbutyrate CEP holder for the record. Additionally, the data presented in the Sodium Phenylbutyrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium Phenylbutyrate DMF.
A Sodium Phenylbutyrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium Phenylbutyrate 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 Sodium Phenylbutyrate suppliers with CEP (COS) on PharmaCompass.
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